510(k) · Cleared

Cleared

CS2 Hip System

K122512510(k) TraditionalCleared Nov 5, 201280-day reviewClass II21 CFR 888.3358

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

Consensus Orthopedics, Inc. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Cleared on Nov 5, 2012 as substantially equivalent to K102399 (Consensus Orthopedics, Inc., 2010) and 17 other predicates after an 80-day review. Its family tree reaches back 7 generations to 1993. 3 later devices descend from it.

Decided: Nov 5, 2012
Review: 80 days
Class: Class II
Product code: LPH
Recalls: None
Predicates: 19

Its longest line of descent runs back 7 generations to K930712 (1993). 78 ancestors in all, the oldest K810258 (1981). 3 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 7 generations backK930712 P.F.C. Total Hip System Porous Coated ModularJohnson & Johnson Orthopaedics, Inc. · 1993
6 generations backK983014 Summit Acetabular SystemJohnson & Johnson Professionals, Inc. · 1998
5 generations backK000306 Pinnacle Acetabular SystemDePuy Orthopaedics, Inc. · 2000 · Recalled
4 generations backK001534 Pinnacle Acetabular SystemDePuy Orthopaedics, Inc. · 2000
3 generations backK031110 Apex Modular Acetabular CupApex Surgical, LLC · 2003
2 generations backK060635 Consensus Acetabular Shell SystemHayes Medical, Inc. · 2006
1 generation backK102399 Consensus Taperset Hip SystemConsensus Orthopedics, Inc. · 2010
This deviceK122512 CS2 Hip SystemConsensus Orthopedics, Inc. · 2012
Descendant · cites it directly · 2 of its ownK123782 Paragon Hip SystemGlobal Manufacturing Technology · 2013
Descendant · 2 generations on · 1 of its ownK142201 OMNI Interface Acetabular SystemOmnlife Science · 2015
Descendant · 3 generations on · 0 of its ownK171156 OMNI Anseris Hip StemOmnilife Science · 2017

Most influential descendants

Showing 3 of 3 · See all

K123782Paragon Hip SystemGlobal Manufacturing Technology · 2013 · cites it directly2descendants
K142201OMNI Interface Acetabular SystemOmnlife Science · 2015 · 2 generations on1descendant
K171156OMNI Anseris Hip StemOmnilife Science · 2017 · 3 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−7	K930712	P.F.C. Total Hip System Porous Coated Modular	Johnson & Johnson Orthopaedics, Inc.	1993	—
−6	K983014	Summit Acetabular System	Johnson & Johnson Professionals, Inc.	1998	—
−5	K000306	Pinnacle Acetabular System	DePuy Orthopaedics, Inc.	2000	1
−4	K001534	Pinnacle Acetabular System	DePuy Orthopaedics, Inc.	2000	—
−3	K031110	Apex Modular Acetabular Cup	Apex Surgical, LLC	2003	—
−2	K060635	Consensus Acetabular Shell System	Hayes Medical, Inc.	2006	—
−1	K102399	Consensus Taperset Hip System	Consensus Orthopedics, Inc.	2010	—
0 (this device)	K122512	CS2 Hip System	Consensus Orthopedics, Inc.	2012	—
+1	K123782	Paragon Hip System	Global Manufacturing Technology	2013	—
+2	K142201	OMNI Interface Acetabular System	Omnlife Science	2015	—
+3	K171156	OMNI Anseris Hip Stem	Omnilife Science	2017	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1981	1	0
1983	1	0
1985	1	0
1986	2	0
1988	1	0
1992	2	0
1993	1	0
1994	13	0
1995	7	0
1996	10	0
1997	5	0
1998	3	0
1999	4	0
2000	4	0
2001	3	0
2002	4	0
2003	5	0
2005	1	0
2006	1	0
2007	1	0
2010	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2013	1	0
2015	1	0
2017	1	0

FIG. 1 — Lineage of K122512, 1993–2017Source: 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 LPH? 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 LPH device

#1 K233498 Stryker Orthopaedics Hip Systems Labeling Updatescore 24.2 · 20 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? (20)

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
*	K102399	Consensus Taperset Hip System Summary page 2 …and mechanicaltesting, the CS2 Hip is substantially equivalent to'legally marketed predicates. Legally Marketed Devices towhichi Substantial E quivalence,is claimed: KI102399 (Consensus Orthopedi'cs Inc.) TAPERSET .HIP S-YSTEM K030151 (fhyts:Meldied, Inc.) CONSENSUS IHP SYSTEM, UNISYNHIPSk YST M K93.519…	Consensus Orthopedics, Inc.	2010	—
*	K030151	Consensus Hip System, Unisyn Hip System Summary page 2 …lent to'legally marketed predicates. Legally Marketed Devices towhichi Substantial E quivalence,is claimed: KI102399 (Consensus Orthopedi'cs Inc.) TAPERSET .HIP S-YSTEM K030151 (fhyts:Meldied, Inc.) CONSENSUS IHP SYSTEM, UNISYNHIPSk YST M K93.5193 (U.S. Medical Products) Consensus' I-ip System.- Porous Co…	Hayes Medical, Inc.	2003	—
*	K935193	Consensus Hip System- Porous Coated Titianium Femoral Stem Summary page 2 …noilogical Ciaructeristics/Sabstanlial Equivalence: TheneW C52 femorAl:stermds-substantially equivalenit to the stemsin the Consensus Hip System (CHS) cleared in,510(k) #K935193 ahd the stein~in the TaperSet IHi0 Systefh .(THS) cleared ini 51 0(lk) #1§l02S99.1 The CS2H4S.stem ~is considered to havethe same…	U.S. Medical Products, Inc.	1994	—
*	K935453	Consensus (TM) Hip System-HA Coated Tianium Fem Stem Summary page 2 …-YSTEM K030151 (fhyts:Meldied, Inc.) CONSENSUS IHP SYSTEM, UNISYNHIPSk YST M K93.5193 (U.S. Medical Products) Consensus' I-ip System.- Porous Coated Titanium Teoral Stem K935453 .(U.S. Medical Products) CONSENSUS(TM) HIP SYSTEM-HA COATED TITANIUMTEMORALSTEM.…	U.S. Medical Products, Inc.	1994	—
*	K933499	Consensus Hip System- Non-Porous Titanium Femoral Stem Summary page 3 …S(TM) HIP SYSTEM-HA COATED TITANIUMTEMORALSTEM. Yazi2 ,1Page 3of 3 K933499 (U.S. Medical Products) CONSENSUS HIP SYSTEM' NON-POROUS TITANIUM FEMORAL STEM K(922561 (U.S$ Medical Products) CONSENSUS(TM) TQT…	U.S. Medical Products, Inc.	1994	—
*	K922561	Consensus (TM) Total Hip System Summary page 3 …Yazi2 ,1Page 3of 3 K933499 (U.S. Medical Products) CONSENSUS HIP SYSTEM' NON-POROUS TITANIUM FEMORAL STEM K(922561 (U.S$ Medical Products) CONSENSUS(TM) TQTAL l.H1PCSYSTEM K922560 (U.S. M edical Products) CONSENSUS(TM) BIPOLAR SYSTEM 1K070061 (…	U.S. Medical Products, Inc.	1993	—
*	K922560	Consensus (TM) Bipolar System Summary page 3 …3of 3 K933499 (U.S. Medical Products) CONSENSUS HIP SYSTEM' NON-POROUS TITANIUM FEMORAL STEM K(922561 (U.S$ Medical Products) CONSENSUS(TM) TQTAL l.H1PCSYSTEM K922560 (U.S. M edical Products) CONSENSUS(TM) BIPOLAR SYSTEM 1K070061 (Hayes Mcdital, Inc,) Consensus Hip System 36 mm CoCt Femoral Head…	U.S. Medical Products, Inc.	1992	—
*	K070061	36MM Cocr Femoral Head and 36MM Acetabular Insert Summary page 3 …SYSTEM' NON-POROUS TITANIUM FEMORAL STEM K(922561 (U.S$ Medical Products) CONSENSUS(TM) TQTAL l.H1PCSYSTEM K922560 (U.S. M edical Products) CONSENSUS(TM) BIPOLAR SYSTEM 1K070061 (Hayes Mcdital, Inc,) Consensus Hip System 36 mm CoCt Femoral Head K(953792 (U S: Medical Products) CONSENSUS ZIRCONIA HEAD SIZE…	Hayes Medical, Inc.	2007	—
*	K953792	Consensus Zirconia Head Size -3.5, 0, +5 Summary page 3 …SENSUS(TM) TQTAL l.H1PCSYSTEM K922560 (U.S. M edical Products) CONSENSUS(TM) BIPOLAR SYSTEM 1K070061 (Hayes Mcdital, Inc,) Consensus Hip System 36 mm CoCt Femoral Head K(953792 (U S: Medical Products) CONSENSUS ZIRCONIA HEAD SIZE -3.5, 0, ±5 K955386 (U S. Medical Products) CONSENSUS ZIRCONIA FEMORAL HEAD…	U.S. Medical Products, Inc.	1995	—
*	K955386	Consensus Zirconia Femoral Head Summary page 3 …(TM) BIPOLAR SYSTEM 1K070061 (Hayes Mcdital, Inc,) Consensus Hip System 36 mm CoCt Femoral Head K(953792 (U S: Medical Products) CONSENSUS ZIRCONIA HEAD SIZE -3.5, 0, ±5 K955386 (U S. Medical Products) CONSENSUS ZIRCONIA FEMORAL HEAD K960339 (U.S. Medical Products) C ONSE NS US 22MM COCRMO'FEMORAL HEAD K96…	U.S. Medical Products, Inc.	1996	—
*	K960339	Consensus 22MM Cocrmo Femoral Head Summary page 3 …System 36 mm CoCt Femoral Head K(953792 (U S: Medical Products) CONSENSUS ZIRCONIA HEAD SIZE -3.5, 0, ±5 K955386 (U S. Medical Products) CONSENSUS ZIRCONIA FEMORAL HEAD K960339 (U.S. Medical Products) C ONSE NS US 22MM COCRMO'FEMORAL HEAD K960 156 (U.S& Medical Products) CONSENSUS 32MM COCRMO FEMORAL. HEA…	U.S. Medical Products, Inc.	1996	—
*	K960156	Consensus 32MM Cocrmo Femoral Head Summary page 3 …NSUS ZIRCONIA HEAD SIZE -3.5, 0, ±5 K955386 (U S. Medical Products) CONSENSUS ZIRCONIA FEMORAL HEAD K960339 (U.S. Medical Products) C ONSE NS US 22MM COCRMO'FEMORAL HEAD K960 156 (U.S& Medical Products) CONSENSUS 32MM COCRMO FEMORAL. HEAD K96015Ij(U.S.MdIical Products) CONSENSUS 26MM4 COCRMO FEMO0RAL HEAD K…	U.S. Medical Products, Inc.	1996	—
*	K960151	Consensus 26MM Cocrmo Femoral Head	U.S. Medical Products, Inc.	1996	—
*	K060635	Consensus Acetabular Shell System Summary page 3 …E NS US 22MM COCRMO'FEMORAL HEAD K960 156 (U.S& Medical Products) CONSENSUS 32MM COCRMO FEMORAL. HEAD K96015Ij(U.S.MdIical Products) CONSENSUS 26MM4 COCRMO FEMO0RAL HEAD K060635 (HayesMedical, Inc.) Consensus:Total Hip System, Acetabular Cup K(030205 (Hayes'Mdical; Inc.) CONSENSUS UNIPOLAR HEAD,,COCR K(02…	Hayes Medical, Inc.	2006	—
*	K030205	Consensus Unipolar Head, Cocr Summary page 3 …S 32MM COCRMO FEMORAL. HEAD K96015Ij(U.S.MdIical Products) CONSENSUS 26MM4 COCRMO FEMO0RAL HEAD K060635 (HayesMedical, Inc.) Consensus:Total Hip System, Acetabular Cup K(030205 (Hayes'Mdical; Inc.) CONSENSUS UNIPOLAR HEAD,,COCR K(02 1466, (Hayes:Medical, Inc.) CONSENSUS ACETABULAR INSERT,- CROSS-LINKED PO…	Hayes Medical, Inc.	2003	—
*	K021466	Consensus Acetabular Insert, Cross-Linked Polyethylene	Hayes Medical, Inc.	2002	—
*	K953198	Corticellous Bone Screw Our reading of the summary gave K953199, FDA’s number for Metro 55G Toric & Spherical (Metrosoft, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Corticellous Bone Screw”.	Hayes Medical, Inc.	1995	—
*	K100933	Consensus CS2 Plus Acetabular Insert Summary page 3 …SUS ACETABULAR INSERT,- CROSS-LINKED POLYETHYLENE 1(0 23 (HayesMediiA, mne') CONSENSUS ACETA BLAR SHELL, TI COATED K(953 199,(HaytepMcdiqcl Inc.) CORTICELLOUS BONE SCREW K1 00933 (Consensusj Consensus Acetabular insert, CS2 Plus K 10542 (Consensus) Consensus Biolox delta.Ceramic Femoral Heads; Non-Clinical…	Consensus Orthopedics, Inc.	2010	—
Kept off the family tree	K010542	FDA’s K010542 is SNN System Including the Tomoguide Option Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree	Surgical Navigation Specialists, Inc.	2001	—
*	—	Consensus Acetabular Shell, Ti Coated Named without a submission number			—

Also cleared against K102399: 6 other devices →

What descends from it? (3)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K123782	Paragon Hip System	Global Manufacturing Technology	2013	2

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

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 19 years and passes through 6 companies; a new generation was cleared every 2.9 years on median.
9 of the 78 ancestors have a recall of any class.
Of its descendants, K123782 (Global Manufacturing Technology, 2013) has gone furthest, with 2 descendants of its own.
6 other devices also cite its predicate K102399.

How does its category compare?

All LPH devices

LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · LPH

12in 2025

2007high 25 (2012) · low 3 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LPH

153in 2025

2007high 410 (2021) · low 76 (2012)2026

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

Recalls per year · LPH

4in 2025

2007high 30 (2012) · low 1 (2008)2026

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

Adverse event reports per year · LPH

6,163in 2025

2007high 7,130 (2019) · low 509 (2007)2025

MAUDE reports naming product code LPH, 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	10	116	16	509
2008	10	86	1	706
2009	3	112	2	1,156
2010	15	100	22	2,007
2011	16	110	26	3,320
2012	25	76	30	3,785
2013	11	135	9	5,002
2014	20	129	3	5,163
2015	18	111	1	5,830
2016	10	150	8	4,900
2017	12	121	14	5,312
2018	9	145	2	5,954
2019	22	164	8	7,130
2020	7	164	6	5,429
2021	8	410	4	5,978
2022	14	247	2	5,223
2023	10	111	2	5,345
2024	6	92	1	5,626
2025	12	153	4	6,163
2026	8	256	2	—

What is it indicated for?

The CS2TM Hip System is designed for total or partial hip arthroplasty and is intended to be used with compatible components of the Consensus Hip System. The indications for use are: A. Significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis. B. Revision of failed femoral head replacement, cup arthroplasty or other hip procedures. C. Proximal femoral fractures. D. Avascular necrosis of the femoral head. E. Non-union…

Read the full statement (187 words)

The CS2TM Hip System is designed for total or partial hip arthroplasty and is intended to be used with compatible components of the Consensus Hip System.

The indications for use are:

A. Significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis.

B. Revision of failed femoral head replacement, cup arthroplasty or other hip procedures.

C. Proximal femoral fractures.

D. Avascular necrosis of the femoral head.

E. Non-union of proximal femoral neck fractures.

F. Other indications such as congenital dysplasia, arthrodesis conversion, coxa magna, coxa plana, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomalacia, osteoporosis, pseudarthrosis conversion, and structural abnormalities.

This CS2TM hip stem is indicated for cementless use.

Indications for Use of the CONSENSUS® BIPOLAR or UNIPOLAR:

A. Primary replacement of the femoral head and neck with very little if any, acetabular degradation noted.

B. Rheumatoid, osteo, and post-traumatic arthritis.

C. Proximal femoral fractures.

D. Avascular necrosis of the femoral head.

E. Non-unions of proximal femoral neck fractures.

F. Revision of failed total hip arthroplasty.

G. Treatment of malunion or nonunion acetabular fractures.

The CONSENSUS® BIPOLAR or UNIPOLAR are intended for cementless use.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K122512 · printed Nov 6, 2026

Cite this page

510(k) Report. “K122512: CS2 Hip System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122512

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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