510(k) · Cleared

Recalled · Class II · 2019

Smith & Nephew, Inc. Hip System Instrumentation

K123598510(k) TraditionalCleared Jun 28, 2013219-day reviewClass II21 CFR 888.3350Recalls 2

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Smith & Nephew, Inc. · JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

Cleared on Jun 28, 2013 as substantially equivalent to K823722 (Richard'S Medical Equip., Inc., 1983) and 100 other predicates after a 219-day review. Its family tree reaches back 9 generations to 1981. It has been recalled 2 times.

Decided: Jun 28, 2013
Review: 219 days
Class: Class II
Product code: JDI
Recalls: 2
Predicates: 102

Its longest line of descent runs back 9 generations to K810258 (1981). 263 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 9 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
5 generations between
3 generations backK071535 Biolox Delta Ceramic Femoral HeadZimmer, Inc. · 2007 · Recalled
2 generations backK082844 Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head…Encore Medical L.P. · 2008 · Recalled
1 generation backK100412 Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc. · 2010
This deviceK123598 Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc. · 2013

Show all 9 generations

Root · 9 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
8 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
7 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
6 generations backK042051 Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · Recalled
5 generations backK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
4 generations backK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
3 generations backK071535 Biolox Delta Ceramic Femoral HeadZimmer, Inc. · 2007 · Recalled
2 generations backK082844 Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head…Encore Medical L.P. · 2008 · Recalled
1 generation backK100412 Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc. · 2010
This deviceK123598 Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc. · 2013

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−9	K810258	Proximal Fermoral Hip Replacement	Biomet, Inc.	1981	—
−8	K974558	Salvage/Onocology Hip and Total Femur System	Biomet, Inc.	1998	—
−7	K032396	Ringloc 36MM Line and Modular Femoral Heads	Biomet, Inc.	2003	3
−6	K042051	Arcomxl Polyethylene Liners	Biomet, Inc.	2005	1
−5	K051411	Arcomxl Polyethylene Liners and Biolox Delta Heads	Biomet, Inc.	2005	1
−4	K061312	36MM Biolox Delta Ceramic Heads	Biomet, Inc.	2006	—
−3	K071535	Biolox Delta Ceramic Femoral Head	Zimmer, Inc.	2007	3
−2	K082844	Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset…	Encore Medical L.P.	2008	1
−1	K100412	Biolox Delta Ceramic Femoral Heads	Smith & Nephew, Inc.	2010	—
0 (this device)	K123598	Smith & Nephew, Inc. Hip System Instrumentation	Smith & Nephew, Inc.	2013	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1983	9	0
1984	2	0
1985	3	0
1986	6	0
1987	4	0
1988	6	0
1990	7	0
1991	5	0
1992	8	0
1993	6	0
1994	26	0
1995	15	0
1996	19	0
1997	24	0
1998	13	0
1999	13	0
2000	13	0
2001	5	0
2002	12	0
2003	11	0
2004	4	0
2005	10	0
2006	10	0
2007	5	0
2008	6	0
2009	4	0
2010	4	0
2011	3	0

FIG. 1 — Lineage of K123598, 1981–2013Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in JDI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new JDI device

#1 K253515 Zimmer Biomet OSS™ Orthopedic Salvage System…score 15.2 · 12 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (102)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

Type	Number	Device	Applicant	Decided	Recalls
*	K823722	Spectron Long, Straight Femoral Prosthes Summary page 1 …hemi-hip} metal/polymer cemented or uncemented prosthesis Device Class: Class Il Panel Code: Orthopaedics/87 Predicate Devices: Spectron Long Straight Femoral Component (K823722); Spectron Primary Femoral Component (K823727); Spectron Proximal Femoral Component (K823723); Spectron Neck Replacement Femoral…	Richard'S Medical Equip., Inc.	1983	—
*	K823727	Spectron Primary Stem Femoral Prosthes Summary page 1 …prosthesis Device Class: Class Il Panel Code: Orthopaedics/87 Predicate Devices: Spectron Long Straight Femoral Component (K823722); Spectron Primary Femoral Component (K823727); Spectron Proximal Femoral Component (K823723); Spectron Neck Replacement Femoral Component (K823724); Spectron Extra Small Femo…	Richard'S Medical Equip., Inc.	1983	—
*	K823723	Spectron Proximal Femoral Prosthesis Summary page 1 …Orthopaedics/87 Predicate Devices: Spectron Long Straight Femoral Component (K823722); Spectron Primary Femoral Component (K823727); Spectron Proximal Femoral Component (K823723); Spectron Neck Replacement Femoral Component (K823724); Spectron Extra Small Femoral Component (K831884); Ti-Fit Femoral Compone…	Richard'S Medical Equip., Inc.	1983	—
*	K823724	Spectron Neck Replacement Prosthesis Summary page 1 …ht Femoral Component (K823722); Spectron Primary Femoral Component (K823727); Spectron Proximal Femoral Component (K823723); Spectron Neck Replacement Femoral Component (K823724); Spectron Extra Small Femoral Component (K831884); Ti-Fit Femoral Component (K873797); Cementra Small Taper Femoral Component (M…	Richard'S Medical Equip., Inc.	1983	—
*	K831884	Spectron Extra-Small, Straight Femoral Summary page 1 …emoral Component (K823727); Spectron Proximal Femoral Component (K823723); Spectron Neck Replacement Femoral Component (K823724); Spectron Extra Small Femoral Component (K831884); Ti-Fit Femoral Component (K873797); Cementra Small Taper Femoral Component (Modular Hip System) (K912593); Ti-Fit Femoral Compo…	Richards Manufacturer Co.	1983	—
*	K873797	TI-Fit Total Hip System Summary page 1 …Proximal Femoral Component (K823723); Spectron Neck Replacement Femoral Component (K823724); Spectron Extra Small Femoral Component (K831884); Ti-Fit Femoral Component (K873797); Cementra Small Taper Femoral Component (Modular Hip System) (K912593); Ti-Fit Femoral Component, Ti-13-13 (K914343); Revision G…	Richards Medical Co., Inc.	1987	—
*	K912593	Modular Hip System Summary page 1 …l Component (K823724); Spectron Extra Small Femoral Component (K831884); Ti-Fit Femoral Component (K873797); Cementra Small Taper Femoral Component (Modular Hip System) (K912593); Ti-Fit Femoral Component, Ti-13-13 (K914343); Revision GT Femoral Component (porous and nonporous and Co-Cr heads)(Echelon) (K9…	Smith & Nephew Richards, Inc.	1991	—
*	K914343	TI-Fit Femoral Component Summary page 1 …moral Component (K831884); Ti-Fit Femoral Component (K873797); Cementra Small Taper Femoral Component (Modular Hip System) (K912593); Ti-Fit Femoral Component, Ti-13-13 (K914343); Revision GT Femoral Component (porous and nonporous and Co-Cr heads)(Echelon) (K963486): Tapered Hip Femoral Components (porous…	Smith & Nephew Richards, Inc.	1992	—
*	K963486	Revision Hip System Summary page 1 …al Component (Modular Hip System) (K912593); Ti-Fit Femoral Component, Ti-13-13 (K914343); Revision GT Femoral Component (porous and nonporous and Co-Cr heads)(Echelon) (K963486): Tapered Hip Femoral Components (porous, & non-porous - Ti) (Synergy) (K963509}; Tapered Hip Femoral Components (HA - Ti); (Syne…	Smith & Nephew Richards, Inc.	1996	—
*	K963509	Global Taper Tapered Hip System, GT Spectron Summary page 1 …(K914343); Revision GT Femoral Component (porous and nonporous and Co-Cr heads)(Echelon) (K963486): Tapered Hip Femoral Components (porous, & non-porous - Ti) (Synergy) (K963509}; Tapered Hip Femoral Components (HA - Ti); (Synergy) (K970337); Spectron & Cobra GT Femoral Components (non-porous - Co-Cr} (K97…	Smith & Nephew Richards, Inc.	1997	—
*	K970337	HA Global Taper (GT) Tapered Hip Stem Summary page 1 …and Co-Cr heads)(Echelon) (K963486): Tapered Hip Femoral Components (porous, & non-porous - Ti) (Synergy) (K963509}; Tapered Hip Femoral Components (HA - Ti); (Synergy) (K970337); Spectron & Cobra GT Femoral Components (non-porous - Co-Cr} (K970351); PLUS Bipolar CoCrMo (K982447); Echelon Primary Hip Stems…	Smith & Nephew, Inc., Orthopaedic Div.	1997	—
*	K970351	Global Taper Spectron Hip Stems Summary page 1 …rous, & non-porous - Ti) (Synergy) (K963509}; Tapered Hip Femoral Components (HA - Ti); (Synergy) (K970337); Spectron & Cobra GT Femoral Components (non-porous - Co-Cr} (K970351); PLUS Bipolar CoCrMo (K982447); Echelon Primary Hip Stems (K983834}; Synergy Cemented Hip Stems (K9903690); Synergy Porous Size…	Smith & Nephew, Inc., Orthopaedic Div.	1997	—
*	K982447	Plus Bipolar Prosthesis Cocrmo Summary page 1 …gy) (K963509}; Tapered Hip Femoral Components (HA - Ti); (Synergy) (K970337); Spectron & Cobra GT Femoral Components (non-porous - Co-Cr} (K970351); PLUS Bipolar CoCrMo (K982447); Echelon Primary Hip Stems (K983834}; Synergy Cemented Hip Stems (K9903690); Synergy Porous Size 8 Hip Stem (K9914850); MODULAR-…	Plus Orthopedics	1998	—
*	K983834	Echelon Hip Stem Summary page 1 …mponents (HA - Ti); (Synergy) (K970337); Spectron & Cobra GT Femoral Components (non-porous - Co-Cr} (K970351); PLUS Bipolar CoCrMo (K982447); Echelon Primary Hip Stems (K983834}; Synergy Cemented Hip Stems (K9903690); Synergy Porous Size 8 Hip Stem (K9914850); MODULAR-PLUS® Revison Stem (K994126); SL-PLUS…	Smith & Nephew, Inc.	1999	—
*	K990369	Synergy Cemented Hip Stem Summary page 1 …); Spectron & Cobra GT Femoral Components (non-porous - Co-Cr} (K970351); PLUS Bipolar CoCrMo (K982447); Echelon Primary Hip Stems (K983834}; Synergy Cemented Hip Stems (K9903690); Synergy Porous Size 8 Hip Stem (K9914850); MODULAR-PLUS® Revison Stem (K994126); SL-PLUS® + SLR-PLUS® with CoCrMo Ball Heads (…	Smith & Nephew, Inc.	1999	—
*	K991485	Synergy Porous Size 8 Hip Stem Summary page 1 …non-porous - Co-Cr} (K970351); PLUS Bipolar CoCrMo (K982447); Echelon Primary Hip Stems (K983834}; Synergy Cemented Hip Stems (K9903690); Synergy Porous Size 8 Hip Stem (K9914850); MODULAR-PLUS® Revison Stem (K994126); SL-PLUS® + SLR-PLUS® with CoCrMo Ball Heads (K001942); K 123598 (Page 2/…	Smith & Nephew, Inc.	1999	—
*	K994126	Modular-Plus Revision Stem Summary page 1 …olar CoCrMo (K982447); Echelon Primary Hip Stems (K983834}; Synergy Cemented Hip Stems (K9903690); Synergy Porous Size 8 Hip Stem (K9914850); MODULAR-PLUS® Revison Stem (K994126); SL-PLUS® + SLR-PLUS® with CoCrMo Ball Heads (K001942); K 123598 (Page 2/9) Summary of Safety and Effectiveness…	Plus Orthopedics	2000	—
*	K001942	SL-Plus and SLR-Plus Stems Summary page 1 …34}; Synergy Cemented Hip Stems (K9903690); Synergy Porous Size 8 Hip Stem (K9914850); MODULAR-PLUS® Revison Stem (K994126); SL-PLUS® + SLR-PLUS® with CoCrMo Ball Heads (K001942); K 123598 (Page 2/9) Summary of Safety and Effectiveness Hip System Instruments Smith & Nephew, Inc. Synergy HA…	Plus Orthopedics	2000	—
*	K002996	Synergy HA Coated Porous Femoral Stems Summary page 2 …of Safety and Effectiveness Hip System Instruments Smith & Nephew, Inc. Synergy HA Coated Porous Femoral Stems (Sizes 8-20 Standard Offset and Sizes 9-20 High Offset) (K002996; \| SL-PLUS® lateralised stem (K021178); Echelon Porous Plus HA Hip Stems (fully porous coated w/HA coating) — HO2COAT (K023302)…	Smith & Nephew, Inc.	2000	—
*	K021178	SL-Plus Lateralized Stem Summary page 2 …Instruments Smith & Nephew, Inc. Synergy HA Coated Porous Femoral Stems (Sizes 8-20 Standard Offset and Sizes 9-20 High Offset) (K002996; \| SL-PLUS® lateralised stem (K021178); Echelon Porous Plus HA Hip Stems (fully porous coated w/HA coating) — HO2COAT (K023302); UNI Hip Stem Fixcone (K024134), MOD…	Plus Orthopedics	2002	—
*	K023302	Echelon Porous Plus HA Hip Stems Summary page 2 …dard Offset and Sizes 9-20 High Offset) (K002996; \| SL-PLUS® lateralised stem (K021178); Echelon Porous Plus HA Hip Stems (fully porous coated w/HA coating) — HO2COAT (K023302); UNI Hip Stem Fixcone (K024134), MODULAR-PLUS® New Generation System (K030971); PLUS Orthopedics cemented stem (IPM); (K03116…	Smith & Nephew, Inc.	2002	—
*	K024134	Uni Hip Stem Summary page 2 …ffset) (K002996; \| SL-PLUS® lateralised stem (K021178); Echelon Porous Plus HA Hip Stems (fully porous coated w/HA coating) — HO2COAT (K023302); UNI Hip Stem Fixcone (K024134), MODULAR-PLUS® New Generation System (K030971); PLUS Orthopedics cemented stem (IPM); (K031165); MODULAR-PLUS®, new gen AX, B…	Plus Orthopedics	2003	—
*	K030971	Modification to Modular Plus Revision Stem Summary page 2 …021178); Echelon Porous Plus HA Hip Stems (fully porous coated w/HA coating) — HO2COAT (K023302); UNI Hip Stem Fixcone (K024134), MODULAR-PLUS® New Generation System (K030971); PLUS Orthopedics cemented stem (IPM); (K031165); MODULAR-PLUS®, new gen AX, BX, CX proximal modules (K032709); Smith & Nephe…	Plus Orthopedics	2003	—
*	K031165	Plus Orthopedics Cemented Hip Stem Summary page 2 …porous coated w/HA coating) — HO2COAT (K023302); UNI Hip Stem Fixcone (K024134), MODULAR-PLUS® New Generation System (K030971); PLUS Orthopedics cemented stem (IPM); (K031165); MODULAR-PLUS®, new gen AX, BX, CX proximal modules (K032709); Smith & Nephew Modular Hip [Emperion) (K042127); ANTHOLOGY Hip…	Plus Orthopedics	2003	—
*	K032709	Modular Plus Hip Stem Summary page 2 …Fixcone (K024134), MODULAR-PLUS® New Generation System (K030971); PLUS Orthopedics cemented stem (IPM); (K031165); MODULAR-PLUS®, new gen AX, BX, CX proximal modules (K032709); Smith & Nephew Modular Hip [Emperion) (K042127); ANTHOLOGY Hip Stems (K052792); Platform Hip Stem (K052275); Emperion Modul…	Plus Orthopedics	2003	—
*	K042127	Smith & Nephew Modular Hip Summary page 2 …ystem (K030971); PLUS Orthopedics cemented stem (IPM); (K031165); MODULAR-PLUS®, new gen AX, BX, CX proximal modules (K032709); Smith & Nephew Modular Hip [Emperion) (K042127); ANTHOLOGY Hip Stems (K052792); Platform Hip Stem (K052275); Emperion Modular Hip Line Additions (Size 9, 21, 23 stems & slee…	Smith & Nephew, Inc.	2004	—
*	K052792	Anthology Hip Stem Summary page 2 …cs cemented stem (IPM); (K031165); MODULAR-PLUS®, new gen AX, BX, CX proximal modules (K032709); Smith & Nephew Modular Hip [Emperion) (K042127); ANTHOLOGY Hip Stems (K052792); Platform Hip Stem (K052275); Emperion Modular Hip Line Additions (Size 9, 21, 23 stems & sleeves, sleeves for stems in K04212…	Smith & Nephew, Inc.	2005	1
*	K052275	Smith & Nephew Platform Hip Stem Summary page 2 …65); MODULAR-PLUS®, new gen AX, BX, CX proximal modules (K032709); Smith & Nephew Modular Hip [Emperion) (K042127); ANTHOLOGY Hip Stems (K052792); Platform Hip Stem (K052275); Emperion Modular Hip Line Additions (Size 9, 21, 23 stems & sleeves, sleeves for stems in K042127) (K052426); Patient Matched…	Smith & Nephew, Inc.	2005	—
*	K052426	Smith & Nephew Modular Hip Summary page 2 …2127); ANTHOLOGY Hip Stems (K052792); Platform Hip Stem (K052275); Emperion Modular Hip Line Additions (Size 9, 21, 23 stems & sleeves, sleeves for stems in K042127) (K052426); Patient Matched Hip Stems (PMHS) (K053246); MIS Hip Stem with Stiktite (K080625); Echelon Titanium Hip System with Gender Cl…	Smith & Nephew, Inc.	2005	—
*	K053246	Patient Matched Hip Stem Summary page 2 …orm Hip Stem (K052275); Emperion Modular Hip Line Additions (Size 9, 21, 23 stems & sleeves, sleeves for stems in K042127) (K052426); Patient Matched Hip Stems (PMHS) (K053246); MIS Hip Stem with Stiktite (K080625); Echelon Titanium Hip System with Gender Claims (Gender Claims removed prior fo 510(k) c…	Smith & Nephew, Inc.	2006	—
*	K080625	Smith & Nephew Mis Hip Stem with Stiktite Summary page 2 …ar Hip Line Additions (Size 9, 21, 23 stems & sleeves, sleeves for stems in K042127) (K052426); Patient Matched Hip Stems (PMHS) (K053246); MIS Hip Stem with Stiktite (K080625); Echelon Titanium Hip System with Gender Claims (Gender Claims removed prior fo 510(k) clearance) (K072817); SL-PLUS Femoral H…	Smith & Nephew, Inc.	2008	1
*	K072817	Echelon Titanium Hip System Summary page 2 …hed Hip Stems (PMHS) (K053246); MIS Hip Stem with Stiktite (K080625); Echelon Titanium Hip System with Gender Claims (Gender Claims removed prior fo 510(k) clearance) (K072817); SL-PLUS Femoral Hips Stems (K072852); SL-PLUS Standard and Lateral Hip Stems S-Version (K072852); SL PLUS MIA Femoral Hip St…	Smith & Nephew, Inc.	2008	—
*	K072852	SL-Plus Standard and Lateral Hip Stems Summary page 2 …p Stem with Stiktite (K080625); Echelon Titanium Hip System with Gender Claims (Gender Claims removed prior fo 510(k) clearance) (K072817); SL-PLUS Femoral Hips Stems (K072852); SL-PLUS Standard and Lateral Hip Stems S-Version (K072852); SL PLUS MIA Femoral Hip Stems (K082371); SLR-PLUS Femoral Stems…	Smith & Nephew, Inc.	2008	—
*	K082371	Smith & Nephew SL-Plus Mia Standard and Lateral Femoral Hip Stem Summary page 2 …prior fo 510(k) clearance) (K072817); SL-PLUS Femoral Hips Stems (K072852); SL-PLUS Standard and Lateral Hip Stems S-Version (K072852); SL PLUS MIA Femoral Hip Stems (K082371); SLR-PLUS Femoral Stems (K093991); MODF Revision Hip System Line Additions - XSM Grit-Blasted Modular Sleeves (Sizes 11mm- 27m…	Smith & Nephew, Inc.	2009	—
*	K093991	SLR-Plus Standard and Lateral Femoral Stems Summary page 2 …); SL-PLUS Femoral Hips Stems (K072852); SL-PLUS Standard and Lateral Hip Stems S-Version (K072852); SL PLUS MIA Femoral Hip Stems (K082371); SLR-PLUS Femoral Stems (K093991); MODF Revision Hip System Line Additions - XSM Grit-Blasted Modular Sleeves (Sizes 11mm- 27mm); MDF Proximal Reamer #1 SZ 11 XS…	Smith & Nephew, Inc.	2010	—
*	K100481	Smith & Nephew MDF Modular Sleeve Summary page 2 …MODF Revision Hip System Line Additions - XSM Grit-Blasted Modular Sleeves (Sizes 11mm- 27mm); MDF Proximal Reamer #1 SZ 11 XSM; and MDF Proximal Reamer #12 SZ 26/27 L. {K100481}; SMF Hip Stem Line Additions - Size -1 and 0 hip stems (Size -1 and 0 broaches/trials, and stem punch are described in the surg…	Smith & Nephew, Inc.	2010	—
*	K103256	Smith & Nephew SMF Hip Stem Summary page 2 …12 SZ 26/27 L. {K100481}; SMF Hip Stem Line Additions - Size -1 and 0 hip stems (Size -1 and 0 broaches/trials, and stem punch are described in the surgical technique} (K103256}; Unipolar Femoral Head, Co-Cr (K896580); Zirconium Alloy Femoral Head (K914878); Unipolar Head, Zirconium Alloy (K934353}; G…	Smith & Nephew, Inc.	2011	2
*	K896580	Uni-Polar Head Summary page 2 …ine Additions - Size -1 and 0 hip stems (Size -1 and 0 broaches/trials, and stem punch are described in the surgical technique} (K103256}; Unipolar Femoral Head, Co-Cr (K896580); Zirconium Alloy Femoral Head (K914878); Unipolar Head, Zirconium Alloy (K934353}; Global Taper Femoral Heads (Co-Cr) (K96348…	Richards Medical Co., Inc.	1990	—
*	K914878	Zirconium Alloy Frmoral Head Summary page 2 …Size -1 and 0 broaches/trials, and stem punch are described in the surgical technique} (K103256}; Unipolar Femoral Head, Co-Cr (K896580); Zirconium Alloy Femoral Head (K914878); Unipolar Head, Zirconium Alloy (K934353}; Global Taper Femoral Heads (Co-Cr) (K963486); Biolox Alumina Ceramic Femoral Head…	Smith & Nephew Richards, Inc.	1992	—
*	K934353	Zirconium Alloy Uni-Polar Head Summary page 2 …ch are described in the surgical technique} (K103256}; Unipolar Femoral Head, Co-Cr (K896580); Zirconium Alloy Femoral Head (K914878); Unipolar Head, Zirconium Alloy (K934353}; Global Taper Femoral Heads (Co-Cr) (K963486); Biolox Alumina Ceramic Femoral Head (12/14 taper) (K981847); Unipolar CoCrMo (…	Smith & Nephew Richards, Inc.	1994	—
*	K981847	Biolox Alumina Ceramic Femoral Head Summary page 2 …loy Femoral Head (K914878); Unipolar Head, Zirconium Alloy (K934353}; Global Taper Femoral Heads (Co-Cr) (K963486); Biolox Alumina Ceramic Femoral Head (12/14 taper) (K981847); Unipolar CoCrMo (K990309); IP Ceramic Head Prostheses in Al203 and ZrO2 (K990261); Biolox Alumina Ceramic Femoral Head, (K99…	Smith & Nephew, Inc.	1998	—
*	K990309	Plus Fracture Head Prosthesis Summary page 2 …Unipolar Head, Zirconium Alloy (K934353}; Global Taper Femoral Heads (Co-Cr) (K963486); Biolox Alumina Ceramic Femoral Head (12/14 taper) (K981847); Unipolar CoCrMo (K990309); IP Ceramic Head Prostheses in Al203 and ZrO2 (K990261); Biolox Alumina Ceramic Femoral Head, (K991162); Zirconium Alloy Femo…	Plus Orthopedics	1999	—
*	K990261	Plus Ceramic Head Prostheses (Alumina and Zirkonia) Summary page 2 …Femoral Heads (Co-Cr) (K963486); Biolox Alumina Ceramic Femoral Head (12/14 taper) (K981847); Unipolar CoCrMo (K990309); IP Ceramic Head Prostheses in Al203 and ZrO2 (K990261); Biolox Alumina Ceramic Femoral Head, (K991162); Zirconium Alloy Femoral Head: 12/14 taper (Total Hip 12/14 Taper Femoral Head…	Plus Orthopedics	1999	—
*	K991162	Biolox Alumina Ceramic Femoral Head Summary page 2 …Ceramic Femoral Head (12/14 taper) (K981847); Unipolar CoCrMo (K990309); IP Ceramic Head Prostheses in Al203 and ZrO2 (K990261); Biolox Alumina Ceramic Femoral Head, (K991162); Zirconium Alloy Femoral Head: 12/14 taper (Total Hip 12/14 Taper Femoral Heads) (K021673}; Zirconium Alloy Femoral Heads: 3ém…	Smith & Nephew, Inc.	2000	—
*	K021673	Total Hip Femoral Head - 12/14 Taper Summary page 2 …rostheses in Al203 and ZrO2 (K990261); Biolox Alumina Ceramic Femoral Head, (K991162); Zirconium Alloy Femoral Head: 12/14 taper (Total Hip 12/14 Taper Femoral Heads) (K021673}; Zirconium Alloy Femoral Heads: 3émm Oxinium & Alumina Ceramic Heads & 36mm XLPE liners (K022958); Smith & Nephew Modular Femo…	Smith & Nephew, Inc.	2002	1
*	K022958	Total Hip Femoral Heads and Liners Summary page 2 …Alloy Femoral Head: 12/14 taper (Total Hip 12/14 Taper Femoral Heads) (K021673}; Zirconium Alloy Femoral Heads: 3émm Oxinium & Alumina Ceramic Heads & 36mm XLPE liners (K022958); Smith & Nephew Modular Femoral Heads (Hemi-Arthroplasty Indications Only) (K061243); Smith & Nephew Modular Femoral Heads - T…	Smith & Nephew, Inc.	2002	1
*	K061243	Smith & Nephew Modular Femoral Head Summary page 2 …onium Alloy Femoral Heads: 3émm Oxinium & Alumina Ceramic Heads & 36mm XLPE liners (K022958); Smith & Nephew Modular Femoral Heads (Hemi-Arthroplasty Indications Only) (K061243); Smith & Nephew Modular Femoral Heads - Taper Sleeve Design (Hemi-Arthroplasty Indications Only) (K062408); Ceramic Ball Heads…	Smith & Nephew, Inc.	2006	1
*	K062408	Smith & Nephew Modular Femoral (Hemi) Head Summary page 2 …w Modular Femoral Heads (Hemi-Arthroplasty Indications Only) (K061243); Smith & Nephew Modular Femoral Heads - Taper Sleeve Design (Hemi-Arthroplasty Indications Only) (K062408); Ceramic Ball Heads, Biolox® Forte Al203, 28, 32, 36 mm (K070928); Oxinium DH (Diffusion Hardened) Femoral Heads (K081566); B…	Smith & Nephew, Inc.	2006	—
*	K070928	Ceramic Ball Heads, 28, 32 and 36 MM Summary page 2 …43); Smith & Nephew Modular Femoral Heads - Taper Sleeve Design (Hemi-Arthroplasty Indications Only) (K062408); Ceramic Ball Heads, Biolox® Forte Al203, 28, 32, 36 mm (K070928); Oxinium DH (Diffusion Hardened) Femoral Heads (K081566); Biolox Delta Ceramic Femoral Heads (K083762); Biolox Delta Ceramic…	Plus Orthopedics AG	2007	—
*	K081566	Smith & Nephew Oxinium DH Femoral Heads Summary page 2 …Design (Hemi-Arthroplasty Indications Only) (K062408); Ceramic Ball Heads, Biolox® Forte Al203, 28, 32, 36 mm (K070928); Oxinium DH (Diffusion Hardened) Femoral Heads (K081566); Biolox Delta Ceramic Femoral Heads (K083762); Biolox Delta Ceramic Femoral Heads (40 and 44mm) (K100412); 10/12 Taper Oxiniu…	Smith & Nephew, Inc.	2008	—
*	K083762	Biolox Delta Ceramic Femoral Heads Summary page 2 …62408); Ceramic Ball Heads, Biolox® Forte Al203, 28, 32, 36 mm (K070928); Oxinium DH (Diffusion Hardened) Femoral Heads (K081566); Biolox Delta Ceramic Femoral Heads (K083762); Biolox Delta Ceramic Femoral Heads (40 and 44mm) (K100412); 10/12 Taper Oxinium Femoral Heads (K110101); K 12…	Smith & Nephew, Inc.	2009	—
*	K100412	Biolox Delta Ceramic Femoral Heads Summary page 2 …mm (K070928); Oxinium DH (Diffusion Hardened) Femoral Heads (K081566); Biolox Delta Ceramic Femoral Heads (K083762); Biolox Delta Ceramic Femoral Heads (40 and 44mm) (K100412); 10/12 Taper Oxinium Femoral Heads (K110101); K 123598 (Page 3/9) Summary of Safety and Effectiveness Hip Syst…	Smith & Nephew, Inc.	2010	—
*	K110101	Taper Oxinium Femoral Head Summary page 2 …Femoral Heads (K081566); Biolox Delta Ceramic Femoral Heads (K083762); Biolox Delta Ceramic Femoral Heads (40 and 44mm) (K100412); 10/12 Taper Oxinium Femoral Heads (K110101); K 123598 (Page 3/9) Summary of Safety and Effectiveness Hip System Instruments Smith & Nephew, inc. Spectron…	Smith & Nephew, Inc.	2011	—
*	K823725	Spectron Protrusio Cup Summary page 3 …(K110101); K 123598 (Page 3/9) Summary of Safety and Effectiveness Hip System Instruments Smith & Nephew, inc. Spectron Protrusio Acetabular Component (K823725); Spectron Metal Backed Acetabular Component (K823729); Spectron All Poly Acetabular Component (K823728); Ti-Fit Acetabular Co…	Richard'S Medical Equip., Inc.	1983	—
*	K823729	Spectron Metal Back Acetabular Component Summary page 3 …of Safety and Effectiveness Hip System Instruments Smith & Nephew, inc. Spectron Protrusio Acetabular Component (K823725); Spectron Metal Backed Acetabular Component (K823729); Spectron All Poly Acetabular Component (K823728); Ti-Fit Acetabular Component (K860275); Opti-Fix Acetabular Component, ceme…	Richard'S Medical Equip., Inc.	1983	—
*	K823728	Spectron Polyethylene Acctubular Compon Summary page 3 …Smith & Nephew, inc. Spectron Protrusio Acetabular Component (K823725); Spectron Metal Backed Acetabular Component (K823729); Spectron All Poly Acetabular Component (K823728); Ti-Fit Acetabular Component (K860275); Opti-Fix Acetabular Component, cemented (K864857); Spectron EF Acetabular Component (…	Richard'S Medical Equip., Inc.	1983	—
*	K860275	TI-Fit Acetabular Component Summary page 3 …o Acetabular Component (K823725); Spectron Metal Backed Acetabular Component (K823729); Spectron All Poly Acetabular Component (K823728); Ti-Fit Acetabular Component (K860275); Opti-Fix Acetabular Component, cemented (K864857); Spectron EF Acetabular Component (K874619); Ti-Thread Acetabular Componen…	Richards Medical Co., Inc.	1986	—
*	K864857	Opti-Fix Acetabular Component Summary page 3 …cked Acetabular Component (K823729); Spectron All Poly Acetabular Component (K823728); Ti-Fit Acetabular Component (K860275); Opti-Fix Acetabular Component, cemented (K864857); Spectron EF Acetabular Component (K874619); Ti-Thread Acetabular Component (K834592); Reflection Acetabular Component, cemen…	Richards Medical Co., Inc.	1987	—
*	K874619	Spectron EF Acetabular Component Summary page 3 …n All Poly Acetabular Component (K823728); Ti-Fit Acetabular Component (K860275); Opti-Fix Acetabular Component, cemented (K864857); Spectron EF Acetabular Component (K874619); Ti-Thread Acetabular Component (K834592); Reflection Acetabular Component, cemented (Modular Acetabular Component) (K920430);…	Richards Medical Co., Inc.	1988	—
Kept off the family tree	K834592	Ti-Thread Acetabular Component Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 3 …Ti-Fit Acetabular Component (K860275); Opti-Fix Acetabular Component, cemented (K864857); Spectron EF Acetabular Component (K874619); Ti-Thread Acetabular Component (K834592); Reflection Acetabular Component, cemented (Modular Acetabular Component) (K920430); HA Ti-Fit Acetabular Component, Bio-Coat…
*	K920430	Modular Acetabular Cup System Summary page 3 …4857); Spectron EF Acetabular Component (K874619); Ti-Thread Acetabular Component (K834592); Reflection Acetabular Component, cemented (Modular Acetabular Component) (K920430); HA Ti-Fit Acetabular Component, Bio-Coat {K922621); Reflection Acetabular Component, uncemented (K932755); Reflection InterF…	Smith & Nephew Richards, Inc.	1992	—
*	K922621	HA TI-Fit Acetabular and Femoral Component Summary page 3 …Ti-Thread Acetabular Component (K834592); Reflection Acetabular Component, cemented (Modular Acetabular Component) (K920430); HA Ti-Fit Acetabular Component, Bio-Coat {K922621); Reflection Acetabular Component, uncemented (K932755); Reflection InterFit Acetabular Shell (K960094); PLUS-FIT® Acetabular…	Smith & Nephew Richards, Inc.	1994	—
*	K932755	Reflection Acetabular Component Summary page 3 …etabular Component, cemented (Modular Acetabular Component) (K920430); HA Ti-Fit Acetabular Component, Bio-Coat {K922621); Reflection Acetabular Component, uncemented (K932755); Reflection InterFit Acetabular Shell (K960094); PLUS-FIT® Acetabular Cup grit blasted (K973077); EPF®-PLUS Acetabular Cup (K…	Smith & Nephew Richards, Inc.	1994	—
*	K960094	Reflection Dual Dimension Shell Summary page 3 …Component) (K920430); HA Ti-Fit Acetabular Component, Bio-Coat {K922621); Reflection Acetabular Component, uncemented (K932755); Reflection InterFit Acetabular Shell (K960094); PLUS-FIT® Acetabular Cup grit blasted (K973077); EPF®-PLUS Acetabular Cup (K972931); Opera Hip System-Acetabular flanged Cup…	Smith & Nephew Richards, Inc.	1996	1
*	K973077	Plus-Fit Acetabular Cup Summary page 3 …ent, Bio-Coat {K922621); Reflection Acetabular Component, uncemented (K932755); Reflection InterFit Acetabular Shell (K960094); PLUS-FIT® Acetabular Cup grit blasted (K973077); EPF®-PLUS Acetabular Cup (K972931); Opera Hip System-Acetabular flanged Cups (K991538); HA Coated Reflection Shells {Reflect…	Plus Orthopedics	1997	—
*	K972931	Plus Epf Acetabular Cup Summary page 3 …Acetabular Component, uncemented (K932755); Reflection InterFit Acetabular Shell (K960094); PLUS-FIT® Acetabular Cup grit blasted (K973077); EPF®-PLUS Acetabular Cup (K972931); Opera Hip System-Acetabular flanged Cups (K991538); HA Coated Reflection Shells {Reflection Acetabular Shell) (K990666); Ref…	Hhl Consulting	1997	—
*	K991538	Opera Cupflanged Acetabular Components Summary page 3 …on InterFit Acetabular Shell (K960094); PLUS-FIT® Acetabular Cup grit blasted (K973077); EPF®-PLUS Acetabular Cup (K972931); Opera Hip System-Acetabular flanged Cups (K991538); HA Coated Reflection Shells {Reflection Acetabular Shell) (K990666); Reflection InterFit HA Coated Shell (K990666); PE-PLUS®…	Smith & Nephew, Inc., Orthopaedic Div.	1999	—
*	K990666	Hydroxyapatite (HA) Reflection Acetabular Shell, Hydroxyapatite (HA) Reflection Interfit… Summary page 3 …blasted (K973077); EPF®-PLUS Acetabular Cup (K972931); Opera Hip System-Acetabular flanged Cups (K991538); HA Coated Reflection Shells {Reflection Acetabular Shell) (K990666); Reflection InterFit HA Coated Shell (K990666); PE-PLUS® Cemented Acetabular Cup (K992153); BICON-PLUS® Acetabular Components…	Smith & Nephew, Inc.	1999	1
*	K992153	PE-Plus Acetabular Cup Summary page 3 …Cups (K991538); HA Coated Reflection Shells {Reflection Acetabular Shell) (K990666); Reflection InterFit HA Coated Shell (K990666); PE-PLUS® Cemented Acetabular Cup (K992153); BICON-PLUS® Acetabular Components, PE Insert) (K992154); BOFOR® Revision Cup Cups + PE insert Std size 28 (K993874}; EPF®-PL…	Plus Orthopedics	1999	—
*	K992154	Bicon-Plus Acetabular Components Summary page 3 …Acetabular Shell) (K990666); Reflection InterFit HA Coated Shell (K990666); PE-PLUS® Cemented Acetabular Cup (K992153); BICON-PLUS® Acetabular Components, PE Insert) (K992154); BOFOR® Revision Cup Cups + PE insert Std size 28 (K993874}; EPF®-PLUS Acetabular Cup Tri-Plama Coated (K994146); Reftection…	Plus Orthopedics	2000	—
*	K993874	Bofor Revision Coup Summary page 3 …hell (K990666); PE-PLUS® Cemented Acetabular Cup (K992153); BICON-PLUS® Acetabular Components, PE Insert) (K992154); BOFOR® Revision Cup Cups + PE insert Std size 28 (K993874}; EPF®-PLUS Acetabular Cup Tri-Plama Coated (K994146); Reftection Cross-Linked UHMWPE Acetabular Components 10 Mrad Irradiation…	Plus Orthopedics	2000	—
*	K994146	Epf-Plus Cementless Press-Fit Acetabular Cup Summary page 3 …2153); BICON-PLUS® Acetabular Components, PE Insert) (K992154); BOFOR® Revision Cup Cups + PE insert Std size 28 (K993874}; EPF®-PLUS Acetabular Cup Tri-Plama Coated (K994146); Reftection Cross-Linked UHMWPE Acetabular Components 10 Mrad Irradiation Dosage (K002747); LPC-PLUS’® Acetabular Cup (K003274…	Plus Orthopedics	2000	—
*	K002747	Reflection Cross-Linked Uhmwpe Acetabular Components Summary page 3 …PE insert Std size 28 (K993874}; EPF®-PLUS Acetabular Cup Tri-Plama Coated (K994146); Reftection Cross-Linked UHMWPE Acetabular Components 10 Mrad Irradiation Dosage (K002747); LPC-PLUS’® Acetabular Cup (K003274); MPF acetabular cup, generation 1 (K011836); MPF acetabular cup, generation 2 (K022120);…	Smith & Nephew, Inc.	2000	—
*	K003274	LPC-Plus Acetabular Cup Summary page 3 …®-PLUS Acetabular Cup Tri-Plama Coated (K994146); Reftection Cross-Linked UHMWPE Acetabular Components 10 Mrad Irradiation Dosage (K002747); LPC-PLUS’® Acetabular Cup (K003274); MPF acetabular cup, generation 1 (K011836); MPF acetabular cup, generation 2 (K022120); Reflection Modified Acetabular Shell…	Plus Orthopedics	2001	—
*	K011836	MPF Acetabular Cup Summary page 3 …46); Reftection Cross-Linked UHMWPE Acetabular Components 10 Mrad Irradiation Dosage (K002747); LPC-PLUS’® Acetabular Cup (K003274); MPF acetabular cup, generation 1 (K011836); MPF acetabular cup, generation 2 (K022120); Reflection Modified Acetabular Shells with HA Coating (peripheral holes) (K022556…	Plus Orthopedics	2001	—
*	K022120	MPF Acetabular Cup Generation 2 Summary page 3 …ar Components 10 Mrad Irradiation Dosage (K002747); LPC-PLUS’® Acetabular Cup (K003274); MPF acetabular cup, generation 1 (K011836); MPF acetabular cup, generation 2 (K022120); Reflection Modified Acetabular Shells with HA Coating (peripheral holes) (K022556); Reflection 36mm XLPE Acet. Liners and 36m…	Plus Orthopedics	2002	—
*	K022556	Reflection Modified Acetabular Shells Summary page 3 …74); MPF acetabular cup, generation 1 (K011836); MPF acetabular cup, generation 2 (K022120); Reflection Modified Acetabular Shells with HA Coating (peripheral holes) (K022556); Reflection 36mm XLPE Acet. Liners and 36mm CoCr Femoral Heads (submission name: Smith & Nephew Hip System) (K022902); Reflect…	Smith & Nephew, Inc.	2002	—
*	K022902	Smith & Nephew Hip System Summary page 3 …tabular Shells with HA Coating (peripheral holes) (K022556); Reflection 36mm XLPE Acet. Liners and 36mm CoCr Femoral Heads (submission name: Smith & Nephew Hip System) (K022902); Reflection 36mm XLPE Acel. Liners and 36mm CoCr Femoral Heads (submission name: Smith & Nephew Hip System) (K022902); Reflect…	Smith & Nephew, Inc.	2002	—
*	K021803	Reflection Constrained Liner Summary page 3 …System) (K022902); Reflection 36mm XLPE Acel. Liners and 36mm CoCr Femoral Heads (submission name: Smith & Nephew Hip System) (K022902); Reflection Constrained Liner (K021803); Reflection Constrained Liner — Sizes 22, 26, & 32 mm (K033442); Reflection 3 Acetabular System - New Shell Design (Existing P…	Smith & Nephew, Inc.	2002	—
*	K033442	Reflection Constrained Liner Summary page 3 …oCr Femoral Heads (submission name: Smith & Nephew Hip System) (K022902); Reflection Constrained Liner (K021803); Reflection Constrained Liner — Sizes 22, 26, & 32 mm (K033442); Reflection 3 Acetabular System - New Shell Design (Existing Porous Coating) with Poly Liner (K061253); Reflection 3-Hole Shel…	Smith & Nephew, Inc.	2003	—
*	K061253	Reflection 3 Acetabular System Summary page 3 …(K021803); Reflection Constrained Liner — Sizes 22, 26, & 32 mm (K033442); Reflection 3 Acetabular System - New Shell Design (Existing Porous Coating) with Poly Liner (K061253); Reflection 3-Hole Shell with Asymmetric Porous Coating (K060630); POLARCUP Dual Mobility System (K070278); REFLECTION 3 Acet…	Smith & Nephew, Inc.	2006	—
*	K060630	Reflection 3-Hole Shell with Asymmetric Porous Coating Summary page 3 …033442); Reflection 3 Acetabular System - New Shell Design (Existing Porous Coating) with Poly Liner (K061253); Reflection 3-Hole Shell with Asymmetric Porous Coating (K060630); POLARCUP Dual Mobility System (K070278); REFLECTION 3 Acetabular System Addition of Stik-tite Porous Coating and Lateralized…	Smith & Nephew, Inc.	2006	—
*	K070278	Polarcup Dual Mobility System Summary page 3 …New Shell Design (Existing Porous Coating) with Poly Liner (K061253); Reflection 3-Hole Shell with Asymmetric Porous Coating (K060630); POLARCUP Dual Mobility System (K070278); REFLECTION 3 Acetabular System Addition of Stik-tite Porous Coating and Lateralized Option (K070756); Reflection XLPE Acetabu…	Plus Orthopedics AG	2007	—
*	K070756	Smith and Nephew Reflection 3 Acetabular System Summary page 3 …ymmetric Porous Coating (K060630); POLARCUP Dual Mobility System (K070278); REFLECTION 3 Acetabular System Addition of Stik-tite Porous Coating and Lateralized Option (K070756); Reflection XLPE Acetabular Liners 38-50mm (KO71160); R3 Constrained Liner Traditional 510(k) (K083566); R3 Multi-Hole Shells…	Smith & Nephew, Inc.	2007	6
*	K071160	Reflection, Tandem Unipolar	Smith & Nephew, Inc.	2007	—
*	K083566	R3 Constrained Liner, Constrained Liner Summary page 3 …em Addition of Stik-tite Porous Coating and Lateralized Option (K070756); Reflection XLPE Acetabular Liners 38-50mm (KO71160); R3 Constrained Liner Traditional 510(k) (K083566); R3 Multi-Hole Shells and 36mm XLPE Liners {K092386); Patient Specific Acetabular Reconstruction Prosthesis (K092098}; R3 XLP…	Smith & Nephew, Inc.	2009	13
*	K092386	R3 Multi-Hole Shells and 36MM Xlpe Acetabular Liners Summary page 3 …d Option (K070756); Reflection XLPE Acetabular Liners 38-50mm (KO71160); R3 Constrained Liner Traditional 510(k) (K083566); R3 Multi-Hole Shells and 36mm XLPE Liners {K092386); Patient Specific Acetabular Reconstruction Prosthesis (K092098}; R3 XLPE Anteverted Liners (K102370); Summary…	Smith & Nephew, Inc.	2009	—
*	K092098	Patient Specific Acetabular Reconstruction Prosthesis Summary page 3 …71160); R3 Constrained Liner Traditional 510(k) (K083566); R3 Multi-Hole Shells and 36mm XLPE Liners {K092386); Patient Specific Acetabular Reconstruction Prosthesis (K092098}; R3 XLPE Anteverted Liners (K102370); Summary of Safety and Effectiveness K 123598 (Page 4/9) Hip System Instru…	Smith & Nephew, Inc.	2010	—
*	K102370	R3 Xlpe Anteverted Liners Summary page 3 …nal 510(k) (K083566); R3 Multi-Hole Shells and 36mm XLPE Liners {K092386); Patient Specific Acetabular Reconstruction Prosthesis (K092098}; R3 XLPE Anteverted Liners (K102370); Summary of Safety and Effectiveness K 123598 (Page 4/9) Hip System Instruments Smith & Nephew, Inc. Spectron C…	Smith & Nephew, Inc.	2011	—
*	K823726	Spectron Conversion Endoprosthesis Cup Summary page 4 …iners (K102370); Summary of Safety and Effectiveness K 123598 (Page 4/9) Hip System Instruments Smith & Nephew, Inc. Spectron Conversion Endoprosthesis (K823726); Orthopedic Cable, titanium (K842977); Opti-Fix Femoral Component, cemented (K860635); Tri-Wedge (Hartford Hip); Femoral Comp…	Richard'S Medical Equip., Inc.	1983	—
*	K842977	Orthopaedic Cable System Summary page 4 …y of Safety and Effectiveness K 123598 (Page 4/9) Hip System Instruments Smith & Nephew, Inc. Spectron Conversion Endoprosthesis (K823726); Orthopedic Cable, titanium (K842977); Opti-Fix Femoral Component, cemented (K860635); Tri-Wedge (Hartford Hip); Femoral Component, cemented (K870128); Ti-Fit Femo…	Richards Medical Co., Inc.	1984	—
*	K860635	Opti-Fix Total Hip System Summary page 4 …Hip System Instruments Smith & Nephew, Inc. Spectron Conversion Endoprosthesis (K823726); Orthopedic Cable, titanium (K842977); Opti-Fix Femoral Component, cemented (K860635); Tri-Wedge (Hartford Hip); Femoral Component, cemented (K870128); Ti-Fit Femoral Head (K873797); Orthopedic Cable, SS (K87515…	Richards Medical Co., Inc.	1986	—
*	K870128	Hartford Total Hip System (Tri-Wedge) Summary page 4 …Endoprosthesis (K823726); Orthopedic Cable, titanium (K842977); Opti-Fix Femoral Component, cemented (K860635); Tri-Wedge (Hartford Hip); Femoral Component, cemented (K870128); Ti-Fit Femoral Head (K873797); Orthopedic Cable, SS (K875156); Opti-Fix Collared Femoral Component (K874868); HA Ti-Fit Fem…	Richards Medical Co., Inc.	1987	—
*	K875156	Stainless Steel Orthopaedic Cable System Summary page 4 …Opti-Fix Femoral Component, cemented (K860635); Tri-Wedge (Hartford Hip); Femoral Component, cemented (K870128); Ti-Fit Femoral Head (K873797); Orthopedic Cable, SS (K875156); Opti-Fix Collared Femoral Component (K874868); HA Ti-Fit Femoral Component, Bio-Interface (K913916); Opti-Fix Femoral Compon…	Richards Medical Co., Inc.	1988	—
*	K874868	Opti-Fix Collared Femoral Components Summary page 4 …Tri-Wedge (Hartford Hip); Femoral Component, cemented (K870128); Ti-Fit Femoral Head (K873797); Orthopedic Cable, SS (K875156); Opti-Fix Collared Femoral Component (K874868); HA Ti-Fit Femoral Component, Bio-Interface (K913916); Opti-Fix Femoral Component, uncemented (K921400); Tri-Wedge Femoral Co…	Richards Medical Co., Inc.	1988	—
*	K913916	Hydroxylapatite Coated TI-Fit Femoral Component Summary page 4 …(K870128); Ti-Fit Femoral Head (K873797); Orthopedic Cable, SS (K875156); Opti-Fix Collared Femoral Component (K874868); HA Ti-Fit Femoral Component, Bio-Interface (K913916); Opti-Fix Femoral Component, uncemented (K921400); Tri-Wedge Femoral Component, uncemented (K921400); HA Ti-Fit Femoral Compo…	Smith & Nephew Richards, Inc.	1991	—
*	K921400	Hip Joint Prothesis Summary page 4 …edic Cable, SS (K875156); Opti-Fix Collared Femoral Component (K874868); HA Ti-Fit Femoral Component, Bio-Interface (K913916); Opti-Fix Femoral Component, uncemented (K921400); Tri-Wedge Femoral Component, uncemented (K921400); HA Ti-Fit Femoral Component, Bio-Coat (K922621); Reflection Acetabular Re…	Smith & Nephew Richards, Inc.	1993	—
*	K962541	Reflection Acetabular Reinforcement Rings Summary page 4 …, uncemented (K921400); Tri-Wedge Femoral Component, uncemented (K921400); HA Ti-Fit Femoral Component, Bio-Coat (K922621); Reflection Acetabular Reinforcement Rings (K962541); Smith & Nephew Orthopaedic Cabling System (K031162); Contour HA Coated Reconstruction Ring (SPS) (K040680}; Accord Cable Sys…	Smith & Nephew Richards, Inc.	1996	—
*	K031162	Smith & Nephew Orthopaedic Cabling System Summary page 4 …uncemented (K921400); HA Ti-Fit Femoral Component, Bio-Coat (K922621); Reflection Acetabular Reinforcement Rings (K962541); Smith & Nephew Orthopaedic Cabling System (K031162); Contour HA Coated Reconstruction Ring (SPS) (K040680}; Accord Cable System - Troch Grip (SPS) (K043252); R3 40 and 44mm XLPE…	Smith & Nephew, Inc.	2003	—
*	K040680	Contour HA Coated Reconstruction Ring Summary page 4 …Coat (K922621); Reflection Acetabular Reinforcement Rings (K962541); Smith & Nephew Orthopaedic Cabling System (K031162); Contour HA Coated Reconstruction Ring (SPS) (K040680}; Accord Cable System - Troch Grip (SPS) (K043252); R3 40 and 44mm XLPE Liners; 40 and 44mm CoCr and Oxinium Femoral Heads and…	Smith & Nephew, Inc.	2004	—
*	K043252	Cabling System Trochanter Hook Summary page 4 …t Rings (K962541); Smith & Nephew Orthopaedic Cabling System (K031162); Contour HA Coated Reconstruction Ring (SPS) (K040680}; Accord Cable System - Troch Grip (SPS) (K043252); R3 40 and 44mm XLPE Liners; 40 and 44mm CoCr and Oxinium Femoral Heads and Titanium Taper Sleeves (K093363); Device Descripti…	Smith & Nephew, Inc.	2005	—
*	K093363	Cocr and Oxinium Femoral Heads and R3 Xlpe Liners Summary page 4 …g (SPS) (K040680}; Accord Cable System - Troch Grip (SPS) (K043252); R3 40 and 44mm XLPE Liners; 40 and 44mm CoCr and Oxinium Femoral Heads and Titanium Taper Sleeves (K093363); Device Description Subject of this Traditional 510(k} Premarket Notification are the Smith & Nephew, Inc. Hip System Instrume…	Smith & Nephew, Inc.	2010	—

Also cleared against K823722: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jan 7, 2019	Class II	Z-0730-2019	Process control	The pin that holds the spring mechanism is not properly mounted. The pin could potentially disassemble.
Nov 16, 2016	Class II	Z-1008-2017	Process control	The firm received complaints of cracks in the weld on the head of the mallet. In the reported cases, some of the lead beads and particles escaped from the mallet into the surgical wound.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 32 years and passes through 4 companies; a new generation was cleared every 1.5 years on median.
42 of the 262 ancestors have a recall of any class.
2 other devices also cite its predicate K823722.

How does its category compare?

All JDI devices

JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

FDA decisions per year · JDI

1in 2025

2007high 7 (2020) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JDI

59in 2024

2007high 247 (2020) · low 59 (2024)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JDI

1in 2025

2007high 77 (2020) · low 0 (2021)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JDI

1,644in 2025

2007high 7,407 (2019) · low 696 (2007)2025

MAUDE reports naming product code JDI, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	3	81	26	696
2008	5	96	6	810
2009	3	65	3	964
2010	0	—	3	2,040
2011	2	—	5	3,160
2012	4	167	4	5,122
2013	3	176	11	5,206
2014	3	98	3	4,968
2015	3	190	1	4,906
2016	4	166	5	3,995
2017	1	—	5	6,135
2018	1	—	1	6,728
2019	2	—	1	7,407
2020	7	247	77	4,015
2021	3	162	0	3,170
2022	3	69	0	1,978
2023	2	—	0	1,635
2024	3	59	0	1,821
2025	1	—	1	1,644
2026	2	—	0	—

What is it indicated for?

Smith & Nephew Uncemented Femoral Stem Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Uncemented Hip Systems and their cleared Indications for Use. Uncemented Femoral Stems are indicated for uncemented use in individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma, inflammatory joint disease such as…

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Uncemented Femoral Stems are indicated for uncemented use in individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma, inflammatory joint disease such as rheumatoid arthritis, or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses such as osteoarthritis; avascular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis; diastrophic variant; old, remote osteomyelitis with an extended drainage-free period; nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity.

Smith & Nephew Cemented Femoral Stem instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Cemented Hip Systems and their cleared Indications for Use.

Cemented Femoral Stems are indicated for cemented use in individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma, inflammatory joint disease such as rheumatoid arthritis, or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses such as osteoarthritis; avascular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis; diastrophic variant; old, remote osteomyelitis with an extended drainage-free period; nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity.

Smith & Nephew PLUS Femoral Stem Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew PLUS Hip Systems and their cleared Indications for Use.

Smith & Nephew Inc PLUS Femoral Stems are indicated for:

The Plus Bipolar prosthesis CoCrMo is intended for use in arthroplasty therapy as a result of femoral neck fractures and is to be used in conjunction with standard femoral replacement implant. This device is intended for Cementless use only.

The Modular-PLUS Revision Stem is intended for cementless use in fractures of the femur where a long section of bone is damaged and the stem must anchor into the distal half of the femur.

The SL-PLUS Stem Primary is intended for treating patients who are candidate for total hip arthroplasty because the natural femoral head and neck has been subject to disease or trauma. The SLR-PLUS STEM, a revision component, is also available to replace previously failed femoral hip arthroplasties. Both components can be used with or without cement. These devices are intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion.

The UNI Hip Stem is intended for treating patients who are candidates for total hip arthroplasty because the natural femoral head has been subject to disease or trauma. It is also intended to treat previously failed hip arthroplasties. This device is intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion.

The SL-PLUS Stem is intended for advanced hip joint wear due to degenerative, posttraumatic or rheumatoid arthritis; fracture or avascular necrosis of the femoral head. The SL-PLUS Lateralized Stem is intended for varus femur forms and trumpet shape of the proximal femur (champagne flute). These stems are for uncemented use only. These devices are intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion.

Smith & Nephew Patient Matched Femoral Stem Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Patient Matched Hip Systems and their cleared Indications for Use.

Smith & Nephew Patient Matched Hip Stems are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant. Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; old, remote osteomyelitis with an extended drainage-free period, in which case, the patient should be warned of an above normal danger of infection postoperatively; treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity.

Smith & Nephew Femoral Head Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Hip Systems and their cleared Indications for Use.

Smith & Nephew Hip Systems are indicated for use in individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma, inflammatory joint disease such as rheumatoid arthritis, or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses such as osteoarthritis; avascular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis; diastrophic variant; old, remote osteomyelitis with an extended drainage-free period; nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity.

Smith & Nephew PLUS Femoral Head Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew PLUS Hip Systems and their cleared Indications for Use.

Smith & Nephew PLUS Hip Systems are indicated for:

The PLUS Fracture Head Prosthesis is intended for use in fractures of the femoral neck and fractures or avascular necrosis of the femoral head with all Plus hip stem prostheses, which have the appropriate 12/14 Morse Taper.

The INTRAPLANT Ceramic Head Prostheses is intended for use in total hip arthroplasty. The indications for use of the total hip replacement prosthesis include: degenerative joint disease including the osteoarthritis and avascular necrosis; rheumatoid arthritis; correction of functional deformity; revision procedure where previous treatments or devices have failed; and treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement, which is unmanageable using other techniques. The INTRAPLANT Ceramic Head Prostheses are to be used only with SL-PLUS and SLR-PLUS hip stems.

Smith & Nephew Hemi-Arthroplasty Only Femoral Head Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Hemi-Arthroplasty Hip Systems and their cleared Indications for Use.

Smith & Nephew Hemi-Arthroplasty Hip Systems are indicated for:

noninflammatory degenerative joint disease including osteoarthritis, osteonecrosis, avascular necrosis and post traumatic arthritis

rheumatoid arthritis

arthritis secondary to a variety of diseases

anomalies and correction of functional deformity such as congenital hip dysplasia or ankylosing spondylitis

revision procedures where other treatments have failed

treatment of proximal femoral non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement

The modular femoral heads are for single use only and are intended to be used as part of a hemihip replacement system when articulating against the natural acetabulum.

Smith & Nephew Acetabular Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Hip Systems and their cleared Indications for Use.

Smith & Nephew PLUS Acetabular Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew PLUS Hip Systems and their cleared Indications for Use.

Smith & Nephew PLUS Hip Systems are indicated for:

The PLUS-FIT Acetabular Cup is intended for all types of arthrosis, such as advanced destruction of the hip joint due to degenerative, post-traumatic or rheumatoid arthritis, fracture or avascular necrosis of the femoral head, sequelae of previous operations, such as internal fixation, joint reconstruction, arthrodesis, hemiarthroplasty or total hip replacement. The same considerations apply to acetabular revisions. In normal cases, however, the surgeon will use an acetabular implant one size larger and in exceptional cases two sizes larger.

The PE-PLUS Acetabular Cup is intended for cemented use in hip arthroplasty where the acetabular socket needs restructuring.

The BICON-PLUS Acetabular Components are intended for use in primary and revision total hip arthroplasty where the acetabular socket needs restructuring.

The BOFOR Revision Cup is intended to be used to replace the acetabulum in revision hip arthroplasty.

The POLARCUP® Dual Mobility System is indicated for: All forms of osteoarthritis; dislocation risks; progressive loss of function of the hip joint as a result of a degenerative posttraumatic; or inflammatory / rheumatic destruction of the joint; femoral head necrosis; proximal femoral fractures (especially femoral neck); status following earlier operations such as osteosynthesis, intertrochanteric osteotomies, arthrodesis or failed joint replacement. The POLARCUP® Dual Mobility System is intended for cemented or press-fit application with or without flanges and pegs for general use in skeletally mature individuals undergoing surgery for rehabilitating hip joints.

Smith & Nephew Constrained Acetabular Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Constrained Hip Systems and their cleared Indications for Use.

Smith & Nephew Constrained Hip Systems are indicated for:

The Reflection Constrained Liner is a cemented or uncemented prosthesis intended to replace a hip joint. The Reflection Constrained Liner is intended for primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, and intra-operative instability and for whom all other options to constrained acetabular components have been considered.

Smith & Nephew Patient Specific Acetabular Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Patient Specific Hip Systems and their cleared Indications for Use.

Smith & Nephew Patient Specific Hip Systems are indicated for:

The Patient Specific Acetabular Reconstruction Prosthesis is intended to be used in primary and revision surgeries where the acetabulum has deficiencies of the acetabular roof, anterior or posterior pillar, medial wall deficiency, and/or protrusion as a result of the indications listed below. The device is for single use and is intended for cementless application.

The Patient Specific Acetabular Reconstruction Prosthesis is indicated as follows: rheumatoid arthritis, avascular necrosis, femoral neck fractures, fracture-dislocation of the hip, and unsuccessful cup arthroplasty, endoprosthesis, femoral osteotomy, or Girdlestone resection. Indications also include osteoarthritis, traumatic arthritis, slipped capital epiphysis, fused hip and diastrophic variant.

Smith & Nephew Hip Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Hip Systems and their cleared Indications for Use.

Smith & Nephew Accord Cable System Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Accord Cable Systems and their cleared Indications for Use.

The Accord Cable System is indicated for:

Trochanteric reattachment whenever the trochanter is osteotomized in any of the procedures listed below:

Primary total hip arthroplasty

Revision total hip arthroplasty

Any procedure using anterolateral or lateral approaches

Smith & Nephew Contour HA Coated Reconstruction Ring Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Contour Systems and their cleared Indications for Use.

The Smith & Nephew Contour System is indicated for use in individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma, inflammatory joint disease such as rheumatoid arthritis, or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses such as osteoarthritis; avascular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis; diastrophic variant; old, remote osteomyelitis with an extended drainage-free period; nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity.

Acetabular reinforcement and reconstruction rings are intended to be used in primary and revision surgeries where the acetabulum has the deficiencies of the acetabular roof, anterior or posterior pillar, medial wall deficiency, and/or protrusion as a result of the indications listed previously. The device is intended for single use.

Smith & Nephew Orthopaedic Cabling System Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Orthopaedic Cabling System and their cleared Indications for Use.

The Orthopaedic Cabling System is indicated for:

General orthopaedic repair procedures including patella fractures, general cerclage, trochanteric reattachment, femur and tibial fractures, prophylactic banding, olecranon fractures, ankle fractures, fixation of spiral fractures in conjunction with intramedullary nailing and screwing fixation techniques.

Trochanteric reattachment whenever the trochanter is osteotomized in any of the procedures listed below:

Primary total hip arthroplasty.

Revision total hip arthroplasty.

Any procedure using anterolateral or lateral approaches.

Smith & Nephew Reflection Acetabular Reinforcement Ring Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Reflection Acetabular Systems and their cleared Indications for Use.

Smith & Nephew Reflection Acetabular Systems are indicated for:

rheumatoid arthritis

avascular necrosis

femoral neck fractures

osteomyelitis

fracture-dislocation of the hip

unsuccessful cup arthroplasty

endoprosthesis

femoral osteoarthritis

traumatic arthritis

slipped capital epiphysis

fused hip

diastrophic variant

Reflection Acetabular Reinforcement Rings are intended to be used in primary and revision surgeries where the acetabulum has the deficiencies of the acetabular roof, anterior or posterior pillar, medial wall deficiency, and/or protrusion as a result of the indications listed previously. The device is for single use.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K123598 · printed Nov 5, 2026

Cite this page

510(k) Report. “K123598: Smith & Nephew, Inc. Hip System Instrumentation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K123598

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026