510(k) · Cleared

Cleared

DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip Prosthesis – MR Conditional, DePuy SUMMIT Cemented Hip Prosthesis – MR Conditional, DePuy SUMMIT FX Cemented Hip Prosthesis – MR Conditional, DePuy SUMMIT Basic Press-Fit Hip Prosthesis – MR Conditional

K231873510(k) TraditionalCleared Jan 19, 2024207-day reviewClass II21 CFR 888.3353

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

Depuy Ireland UC · MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate

Cleared on Jan 19, 2024 as substantially equivalent to K102080 (Depuy (Ireland), 2010) and 70 other predicates after a 207-day review. Its family tree reaches back 18 generations to 1994. 5 later devices descend from it.

Decided: Jan 19, 2024
Review: 207 days
Class: Class II
Product code: MEH
Recalls: None
Predicates: 71

Its longest line of descent runs back 18 generations to K941847 (1994). 286 ancestors in all, the oldest K800894 (1980). 5 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 18 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
14 generations between
3 generations backK170339 Summit Hip SystemDePuy Orthopaedics, Inc. · 2018
2 generations backK193398 Summit DuoFix HA CoatingDePuy Orthopaedics, Inc. · 2020
1 generation backK202472 ACTIS Duofix Hip ProsthesisDePuy Orthopaedics, Inc. · 2020
This deviceK231873 DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT…Depuy Ireland UC · 2024
Descendant · cites it directly · 1 of its ownK251292 RECLAIM Monobloc Revision Femoral StemDepuy Ireland UC · 2025
Descendant · cites it directly · 1 of its ownK243977 EMPHASYS Acetabular SystemDepuy Ireland UC · 2025
Descendant · 2 generations on · 0 of its ownK260173 M-Vizion Femoral Revision System ExtensionMedacta International S.A. · 2026
Descendant · 2 generations on · 0 of its ownK252067 Velora Acetabular SystemRestor3D, Inc. · 2025
Descendant · cites it directly · 0 of its ownK242084 EMPHASYS Acetabular Shell with RapiTite HADepuy Ireland UC · 2024

Show all 18 generations

Root · 18 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
17 generations backK964650 TCP-Coated Porocoat Aml Femoral Hip ProsthesisDepuy, Inc. · 1997
16 generations backK980711 Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic…Zimmer, Inc. · 1998 · Recalled
15 generations backK001277 Triflange Acetabular Cup SystemDePuy Orthopaedics, Inc. · 2000
14 generations backK031495 Pinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc. · 2003
13 generations backK042344 Excia Total Hip SystemAesculap, Inc. · 2005 · Recalled
12 generations backK060918 Excia Total Hip System 12/14 Trunnion with Ceramic HeadAesculap, Inc. · 2006
11 generations backK062684 Excia Total Hip System 36MM Ceramic HeadAesculap, Inc. · 2006
10 generations backK082991 Biolox Delta Ceramic Femoral HeadAesculap Implant Systems, Inc. · 2008
9 generations backK083495 Modification to: Metha Hip SystemAesculap Implant Systems, Inc. · 2009
8 generations backK090845 Apex Arc Hip StemOmni Life Science, Inc. · 2010 · Recalled
7 generations backK111193 Apex Arc Hip StemOmni Life Science, Inc. · 2011
6 generations backK113242 Apex Arc Hip StemOmni Life Science, Inc. · 2012
5 generations backK123991 Depuy Corail Amt Hip ProsthesisDepuy France S.A.S. · 2013 · Recalled
4 generations backK150862 DePuy Actis Duofox Hip ProsthesisDePuy Orthopaedics, Inc. · 2015 · Recalled
3 generations backK170339 Summit Hip SystemDePuy Orthopaedics, Inc. · 2018
2 generations backK193398 Summit DuoFix HA CoatingDePuy Orthopaedics, Inc. · 2020
1 generation backK202472 ACTIS Duofix Hip ProsthesisDePuy Orthopaedics, Inc. · 2020
This deviceK231873 DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT…Depuy Ireland UC · 2024

Most influential descendants

Showing 5 of 5 · See all

K251292RECLAIM Monobloc Revision Femoral StemDepuy Ireland UC · 2025 · cites it directly1descendant
K243977EMPHASYS Acetabular SystemDepuy Ireland UC · 2025 · cites it directly1descendant
K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A. · 2026 · 2 generations on0descendants
K252067Velora Acetabular SystemRestor3D, Inc. · 2025 · 2 generations on0descendants
K242084EMPHASYS Acetabular Shell with RapiTite HADepuy Ireland UC · 2024 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−18	K941847	5/8 Porocoat Aml Hip Porocoat Porous Coating	Depuy, Inc.	1994	—
−17	K964650	TCP-Coated Porocoat Aml Femoral Hip Prosthesis	Depuy, Inc.	1997	—
−16	K980711	Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic Coating	Zimmer, Inc.	1998	1
−15	K001277	Triflange Acetabular Cup System	DePuy Orthopaedics, Inc.	2000	—
−14	K031495	Pinnacle Duofix HA Acetabular Cup Prosthesis	DePuy Orthopaedics, Inc.	2003	—
−13	K042344	Excia Total Hip System	Aesculap, Inc.	2005	10
−12	K060918	Excia Total Hip System 12/14 Trunnion with Ceramic Head	Aesculap, Inc.	2006	—
−11	K062684	Excia Total Hip System 36MM Ceramic Head	Aesculap, Inc.	2006	—
−10	K082991	Biolox Delta Ceramic Femoral Head	Aesculap Implant Systems, Inc.	2008	—
−9	K083495	Modification to: Metha Hip System	Aesculap Implant Systems, Inc.	2009	—
−8	K090845	Apex Arc Hip Stem	Omni Life Science, Inc.	2010	2
−7	K111193	Apex Arc Hip Stem	Omni Life Science, Inc.	2011	—
−6	K113242	Apex Arc Hip Stem	Omni Life Science, Inc.	2012	—
−5	K123991	Depuy Corail Amt Hip Prosthesis	Depuy France S.A.S.	2013	1
−4	K150862	DePuy Actis Duofox Hip Prosthesis	DePuy Orthopaedics, Inc.	2015	1
−3	K170339	Summit Hip System	DePuy Orthopaedics, Inc.	2018	—
−2	K193398	Summit DuoFix HA Coating	DePuy Orthopaedics, Inc.	2020	—
−1	K202472	ACTIS Duofix Hip Prosthesis	DePuy Orthopaedics, Inc.	2020	—
0 (this device)	K231873	DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…	Depuy Ireland UC	2024	—
+1	K251292	RECLAIM Monobloc Revision Femoral Stem	Depuy Ireland UC	2025	—
+1	K243977	EMPHASYS Acetabular System	Depuy Ireland UC	2025	—
+2	K260173	M-Vizion Femoral Revision System Extension	Medacta International S.A.	2026	—
+2	K252067	Velora Acetabular System	Restor3D, Inc.	2025	—
+1	K242084	EMPHASYS Acetabular Shell with RapiTite HA	Depuy Ireland UC	2024	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1980	2	0
1981	2	0
1984	1	0
1985	2	0
1986	1	0
1987	6	0
1988	3	0
1989	1	0
1990	4	0
1991	5	0
1992	8	0
1993	4	0
1994	24	0
1995	17	0
1996	18	0
1997	11	0
1998	11	0
1999	7	0
2000	21	0
2001	15	0
2002	11	0
2003	11	0
2004	14	0
2005	10	0
2006	8	0
2007	8	0
2008	7	0
2009	5	0
2010	6	0
2011	6	0
2012	1	0
2013	2	0
2014	1	0
2016	1	0
2018	2	0
2019	3	0
2020	1	0
2021	3	0
2022	3	0
2023	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2024	1	0
2025	3	0
2026	1	0

FIG. 1 — Lineage of K231873, 1994–2026Source: 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 MEH? 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 MEH device

#1 K210581 Actis DuoFix Hip Prosthesis- Collarlessscore 23.9 · 16 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? (71)

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K102080	Depuy Reclaim Revision Hip System Summary page 8 …4 of 27 DEPARTMENT OF HEALTH AND HUMAN SERVICES Form Approved: OMB No. 0910-0120 Indications for Use See PRA Statement below. 510(k) Number (if known) K102080/K221462 Device Name RECLAIM MODULAR REVISION HIP SYSTEM, RECLAIM MONOBLOC REVISION HIP SYSTEM Indications for Use (Describe) T…	Depuy (Ireland)	2010	3
*	K982918	Depuy C-Stem System Summary page 7 …3 of 27 DEPARTMENT OF HEALTH AND HUMAN SERVICES Form Approved: OMB No. 0910-0120 Indications for Use See PRA Statement below. 510(k) Number (if known) K982918/K013350/K042959/K082239/K220216/K093736/K851422/K910664/K934412/K961939/K903084/K073570 Device Name C-STEM SYSTEM, C-STEM AMT H…	DePuy Orthopaedics, Inc.	1998	—
*	K013350	Modification to Depuy C-Stem System Summary page 7 …DEPARTMENT OF HEALTH AND HUMAN SERVICES Form Approved: OMB No. 0910-0120 Indications for Use See PRA Statement below. 510(k) Number (if known) K982918/K013350/K042959/K082239/K220216/K093736/K851422/K910664/K934412/K961939/K903084/K073570 Device Name C-STEM SYSTEM, C-STEM AMT HIP PROST…	DePuy Orthopaedics, Inc.	2001	—
*	K042959	Depuy C-Stem Amt Hip Prosthesis Summary page 7 …ge 7 === DEPARTMENT OF HEALTH AND HUMAN SERVICES Form Approved: OMB No. 0910-0120 Indications for Use See PRA Statement below. 510(k) Number (if known) K982918/K013350/K042959/K082239/K220216/K093736/K851422/K910664/K934412/K961939/K903084/K073570 Device Name C-STEM SYSTEM, C-STEM AMT HIP PROSTHESIS, C…	DePuy Orthopaedics, Inc.	2004	—
*	K082239	Depuy C-Stem Amt Summary page 7 …DEPARTMENT OF HEALTH AND HUMAN SERVICES Form Approved: OMB No. 0910-0120 Indications for Use See PRA Statement below. 510(k) Number (if known) K982918/K013350/K042959/K082239/K220216/K093736/K851422/K910664/K934412/K961939/K903084/K073570 Device Name C-STEM SYSTEM, C-STEM AMT HIP PROSTHESIS, CORAIL RE…	DePuy Orthopaedics, Inc.	2008	—
*	K220216	C-Stem AMT LE Prosthesis Summary page 7 …ENT OF HEALTH AND HUMAN SERVICES Form Approved: OMB No. 0910-0120 Indications for Use See PRA Statement below. 510(k) Number (if known) K982918/K013350/K042959/K082239/K220216/K093736/K851422/K910664/K934412/K961939/K903084/K073570 Device Name C-STEM SYSTEM, C-STEM AMT HIP PROSTHESIS, CORAIL REVISION H…	Depuy Ireland UC	2022	—
*	K093736	Depuy Corail Hip System, Revision Stem Summary page 7 …EALTH AND HUMAN SERVICES Form Approved: OMB No. 0910-0120 Indications for Use See PRA Statement below. 510(k) Number (if known) K982918/K013350/K042959/K082239/K220216/K093736/K851422/K910664/K934412/K961939/K903084/K073570 Device Name C-STEM SYSTEM, C-STEM AMT HIP PROSTHESIS, CORAIL REVISION HIP PROST…	DePuy Orthopaedics, Inc.	2011	—
*	K851422	S-Rom 135 Femoral Stem & Collar (Part of S-Rom Hip Summary page 7 …D HUMAN SERVICES Form Approved: OMB No. 0910-0120 Indications for Use See PRA Statement below. 510(k) Number (if known) K982918/K013350/K042959/K082239/K220216/K093736/K851422/K910664/K934412/K961939/K903084/K073570 Device Name C-STEM SYSTEM, C-STEM AMT HIP PROSTHESIS, CORAIL REVISION HIP PROSTHESIS, S…	Joint Medical Products Corp.	1985	—
*	K910664	Mod. Trochanter Screw & Washer W/ Anodized Titan. Summary page 7 …SERVICES Form Approved: OMB No. 0910-0120 Indications for Use See PRA Statement below. 510(k) Number (if known) K982918/K013350/K042959/K082239/K220216/K093736/K851422/K910664/K934412/K961939/K903084/K073570 Device Name C-STEM SYSTEM, C-STEM AMT HIP PROSTHESIS, CORAIL REVISION HIP PROSTHESIS, S-ROM FEM…	Medimix Products, Inc.	1992	—
*	K934412	Coated ZT Proximal Sleeve Summary page 7 …Form Approved: OMB No. 0910-0120 Indications for Use See PRA Statement below. 510(k) Number (if known) K982918/K013350/K042959/K082239/K220216/K093736/K851422/K910664/K934412/K961939/K903084/K073570 Device Name C-STEM SYSTEM, C-STEM AMT HIP PROSTHESIS, CORAIL REVISION HIP PROSTHESIS, S-ROM FEMORAL TOT…	Joint Medical Products Corp.	1994	—
*	K961939	S-Rom Femoral Hip Stem (Sizes 12 X 06 X 115 and 12 X 07 X 115) Summary page 7 …proved: OMB No. 0910-0120 Indications for Use See PRA Statement below. 510(k) Number (if known) K982918/K013350/K042959/K082239/K220216/K093736/K851422/K910664/K934412/K961939/K903084/K073570 Device Name C-STEM SYSTEM, C-STEM AMT HIP PROSTHESIS, CORAIL REVISION HIP PROSTHESIS, S-ROM FEMORAL TOTA HIP SY…	Johnson & Johnson Professionals, Inc.	1996	—
*	K073570	Depuy Tri-Lock Bone Preservation Stem Summary page 7 …0910-0120 Indications for Use See PRA Statement below. 510(k) Number (if known) K982918/K013350/K042959/K082239/K220216/K093736/K851422/K910664/K934412/K961939/K903084/K073570 Device Name C-STEM SYSTEM, C-STEM AMT HIP PROSTHESIS, CORAIL REVISION HIP PROSTHESIS, S-ROM FEMORAL TOTA HIP SYSTEM, S-ROM TOTA…	DePuy Orthopaedics, Inc.	2008	—
*	K211657	EMPHASYS Femoral Stems Summary page 10 …SERVICES Form Approved: OMB No. 0910-0120 Indications for Use See PRA Statement below. 510(k) Number (if known) K001991/K011489/K013352/K023453/K030122/K202472/K210581/K211657/K192946 Device Name SUMMIT POROCOAT, SUMMIT DUOFIX, SUMMIT CEMENTED, SUMMIT FX CEMENTED, SUMMIT BASIC PRESS-FIT HIP PROSTHESIS,…	Depuy Ireland UC	2021	—
*	K942370	Depuy Cemented Hip Prosthesis Summary page 6 …2 of 27 DEPARTMENT OF HEALTH AND HUMAN SERVICES Form Approved: OMB No. 0910-0120 Indications for Use See PRA Statement below. 510(k) Number (if known) K942370/K961619 Device Name ENDURANCE CEMENTED HIP PROSTHESIS, ENDURANCE CALCAR PROSTHESIS Indications for Use (Describe) Total hip rep…	Depuy, Inc.	1994	—
*	K961619	Depuy Endurance Calcar Hip Prosthesis Summary page 6 …DEPARTMENT OF HEALTH AND HUMAN SERVICES Form Approved: OMB No. 0910-0120 Indications for Use See PRA Statement below. 510(k) Number (if known) K942370/K961619 Device Name ENDURANCE CEMENTED HIP PROSTHESIS, ENDURANCE CALCAR PROSTHESIS Indications for Use (Describe) Total hip replacement…	Depuy, Inc.	1996	—
*	K903084	Modular Cathcart Fracture System Summary page 7 …OMB No. 0910-0120 Indications for Use See PRA Statement below. 510(k) Number (if known) K982918/K013350/K042959/K082239/K220216/K093736/K851422/K910664/K934412/K961939/K903084/K073570 Device Name C-STEM SYSTEM, C-STEM AMT HIP PROSTHESIS, CORAIL REVISION HIP PROSTHESIS, S-ROM FEMORAL TOTA HIP SYSTEM, S-…	Depuy, Inc.	1990	1
*	K221462	DePuy Reclaim Monobloc Revision Femoral Stem Summary page 8 …DEPARTMENT OF HEALTH AND HUMAN SERVICES Form Approved: OMB No. 0910-0120 Indications for Use See PRA Statement below. 510(k) Number (if known) K102080/K221462 Device Name RECLAIM MODULAR REVISION HIP SYSTEM, RECLAIM MONOBLOC REVISION HIP SYSTEM Indications for Use (Describe) The DePuy…	Depuy Ireland UC	2022	—
*	K953703	Depuy Vision Solution Hip Prosthesis Summary page 9 …5 of 27 DEPARTMENT OF HEALTH AND HUMAN SERVICES Form Approved: OMB No. 0910-0120 Indications for Use See PRA Statement below. 510(k) Number (if known) K953703/K030979/K060581 Device Name VISION SOLUTION HIP PROSTHESIS, SOLUTION SYSTEM HIP PROSTHESIS Indications for Use (Describe) Total…	Depuy, Inc.	1996	—
*	K030979	Modification to Depuy Solution System Hip Prosthesis Summary page 9 …DEPARTMENT OF HEALTH AND HUMAN SERVICES Form Approved: OMB No. 0910-0120 Indications for Use See PRA Statement below. 510(k) Number (if known) K953703/K030979/K060581 Device Name VISION SOLUTION HIP PROSTHESIS, SOLUTION SYSTEM HIP PROSTHESIS Indications for Use (Describe) Total hip rep…	DePuy Orthopaedics, Inc.	2003	—
*	K060581	Depuy Solution System Hip Prosthesis Summary page 9 …ge 9 === DEPARTMENT OF HEALTH AND HUMAN SERVICES Form Approved: OMB No. 0910-0120 Indications for Use See PRA Statement below. 510(k) Number (if known) K953703/K030979/K060581 Device Name VISION SOLUTION HIP PROSTHESIS, SOLUTION SYSTEM HIP PROSTHESIS Indications for Use (Describe) Total hip replacement…	DePuy Orthopaedics, Inc.	2006	20
*	K001991	Titan Porocoat Hip Prosthesis Summary page 10 …6 of 27 DEPARTMENT OF HEALTH AND HUMAN SERVICES Form Approved: OMB No. 0910-0120 Indications for Use See PRA Statement below. 510(k) Number (if known) K001991/K011489/K013352/K023453/K030122/K202472/K210581/K211657/K192946 Device Name SUMMIT POROCOAT, SUMMIT DUOFIX, SUMMIT CEMENTED, SU…	DePuy Orthopaedics, Inc.	2000	—
*	K011489	Summit Duofix Hip Prosthesis Summary page 10 …DEPARTMENT OF HEALTH AND HUMAN SERVICES Form Approved: OMB No. 0910-0120 Indications for Use See PRA Statement below. 510(k) Number (if known) K001991/K011489/K013352/K023453/K030122/K202472/K210581/K211657/K192946 Device Name SUMMIT POROCOAT, SUMMIT DUOFIX, SUMMIT CEMENTED, SUMMIT FX…	DePuy Orthopaedics, Inc.	2001	—
*	K013352	Summit Cemented Hip Prosthesis Summary page 10 …e 10 === DEPARTMENT OF HEALTH AND HUMAN SERVICES Form Approved: OMB No. 0910-0120 Indications for Use See PRA Statement below. 510(k) Number (if known) K001991/K011489/K013352/K023453/K030122/K202472/K210581/K211657/K192946 Device Name SUMMIT POROCOAT, SUMMIT DUOFIX, SUMMIT CEMENTED, SUMMIT FX CEMENTED…	DePuy Orthopaedics, Inc.	2001	—
*	K023453	Depuy Summit FX Cemented Hip Prosthesis Summary page 10 …DEPARTMENT OF HEALTH AND HUMAN SERVICES Form Approved: OMB No. 0910-0120 Indications for Use See PRA Statement below. 510(k) Number (if known) K001991/K011489/K013352/K023453/K030122/K202472/K210581/K211657/K192946 Device Name SUMMIT POROCOAT, SUMMIT DUOFIX, SUMMIT CEMENTED, SUMMIT FX CEMENTED, SUMMIT…	DePuy Orthopaedics, Inc.	2002	—
*	K030122	Depuy Summit Basic Press-Fit Hip Stem Summary page 10 …ENT OF HEALTH AND HUMAN SERVICES Form Approved: OMB No. 0910-0120 Indications for Use See PRA Statement below. 510(k) Number (if known) K001991/K011489/K013352/K023453/K030122/K202472/K210581/K211657/K192946 Device Name SUMMIT POROCOAT, SUMMIT DUOFIX, SUMMIT CEMENTED, SUMMIT FX CEMENTED, SUMMIT BASIC P…	DePuy Orthopaedics, Inc.	2003	—
*	K202472	ACTIS Duofix Hip Prosthesis Summary page 10 …EALTH AND HUMAN SERVICES Form Approved: OMB No. 0910-0120 Indications for Use See PRA Statement below. 510(k) Number (if known) K001991/K011489/K013352/K023453/K030122/K202472/K210581/K211657/K192946 Device Name SUMMIT POROCOAT, SUMMIT DUOFIX, SUMMIT CEMENTED, SUMMIT FX CEMENTED, SUMMIT BASIC PRESS-FIT…	DePuy Orthopaedics, Inc.	2020	—
*	K210581	Actis DuoFix Hip Prosthesis- Collarless Summary page 10 …D HUMAN SERVICES Form Approved: OMB No. 0910-0120 Indications for Use See PRA Statement below. 510(k) Number (if known) K001991/K011489/K013352/K023453/K030122/K202472/K210581/K211657/K192946 Device Name SUMMIT POROCOAT, SUMMIT DUOFIX, SUMMIT CEMENTED, SUMMIT FX CEMENTED, SUMMIT BASIC PRESS-FIT HIP PRO…	Depuy Ireland UC	2021	—
*	K192946	DePuy Corail AMT Hip Prosthesis Summary page 10 …Form Approved: OMB No. 0910-0120 Indications for Use See PRA Statement below. 510(k) Number (if known) K001991/K011489/K013352/K023453/K030122/K202472/K210581/K211657/K192946 Device Name SUMMIT POROCOAT, SUMMIT DUOFIX, SUMMIT CEMENTED, SUMMIT FX CEMENTED, SUMMIT BASIC PRESS-FIT HIP PROSTHESIS, ACTIS D…	DePuy Orthopaedics, Inc.	2019	—
*	K200854	DePuy PINNACLE Dual Mobility Liner Summary page 13 …9 of 27 DEPARTMENT OF HEALTH AND HUMAN SERVICES Form Approved: OMB No. 0910-0120 Indications for Use See PRA Statement below. 510(k) Number (if known) K200854 Device Name PINNACLE DUAL MOBILITY LINER Indications for Use (Describe) Total hip replacement or hip arthroplasty is indicated…	Depuy Ireland UC	2020	—
*	K203532	BI-MENTUM™ ALTRX® Dual Mobility Liner Summary page 12 …SERVICES Form Approved: OMB No. 0910-0120 Food and Drug Administration Expiration Date: 06/30/2023 Indications for Use See PRA Statement below. 510(k) Number (if known) K203532 Device Name BI-MENTUM ALTRX DUAL MOBILITY LINERS Indications for Use (Describe) BI-MENTUM™ ALTRX® Dual Mobility Liner is indic…	Depuy Ireland UC	2021	—
*	K072963	Depuy Pinnacle Altrx Acetabular Liners Summary page 14 …0 of 27 DEPARTMENT OF HEALTH AND HUMAN SERVICES Form Approved: OMB No. 0910-0120 Indications for Use See PRA Statement below. 510(k) Number (if known) K072963, K102423, K132959, K090998, K093646, K033273, K001534 Device Name PINNACLE ALTRX ACETABULAR LINERS, PINNACLE 100 GRIPTION CUPS,…	DePuy Orthopaedics, Inc.	2008	—
*	K102423	Depuy Pinnacle Altrx Acetabular Liners Summary page 14 …DEPARTMENT OF HEALTH AND HUMAN SERVICES Form Approved: OMB No. 0910-0120 Indications for Use See PRA Statement below. 510(k) Number (if known) K072963, K102423, K132959, K090998, K093646, K033273, K001534 Device Name PINNACLE ALTRX ACETABULAR LINERS, PINNACLE 100 GRIPTION CUPS, PINNACLE…	DePuy Orthopaedics, Inc.	2010	2
*	K132959	Depuy Pinnacle Altrx Acetabular Liners Summary page 14 …14 === DEPARTMENT OF HEALTH AND HUMAN SERVICES Form Approved: OMB No. 0910-0120 Indications for Use See PRA Statement below. 510(k) Number (if known) K072963, K102423, K132959, K090998, K093646, K033273, K001534 Device Name PINNACLE ALTRX ACETABULAR LINERS, PINNACLE 100 GRIPTION CUPS, PINNACLE GRIPTION…	DePuy Orthopaedics, Inc.	2014	—
*	K090998	Depuy Pinnacle 100 with Gription Acetabular Cups Summary page 14 …PARTMENT OF HEALTH AND HUMAN SERVICES Form Approved: OMB No. 0910-0120 Indications for Use See PRA Statement below. 510(k) Number (if known) K072963, K102423, K132959, K090998, K093646, K033273, K001534 Device Name PINNACLE ALTRX ACETABULAR LINERS, PINNACLE 100 GRIPTION CUPS, PINNACLE GRIPTION CUPS, PIN…	DePuy Orthopaedics, Inc.	2009	—
*	K093646	Depuy Pinnacle with Gription Acetabular Cups Summary page 14 …OF HEALTH AND HUMAN SERVICES Form Approved: OMB No. 0910-0120 Indications for Use See PRA Statement below. 510(k) Number (if known) K072963, K102423, K132959, K090998, K093646, K033273, K001534 Device Name PINNACLE ALTRX ACETABULAR LINERS, PINNACLE 100 GRIPTION CUPS, PINNACLE GRIPTION CUPS, PINNACLE ACE…	DePuy Orthopaedics, Inc.	2009	—
*	K033273	Depuy Pinnacle Acetabular Cup System, Esl Marathon Polyethylene Liners, and Depuy Ultima… Summary page 14 …AND HUMAN SERVICES Form Approved: OMB No. 0910-0120 Indications for Use See PRA Statement below. 510(k) Number (if known) K072963, K102423, K132959, K090998, K093646, K033273, K001534 Device Name PINNACLE ALTRX ACETABULAR LINERS, PINNACLE 100 GRIPTION CUPS, PINNACLE GRIPTION CUPS, PINNACLE ACETABULAR E…	DePuy Orthopaedics, Inc.	2004	—
*	K001534	Pinnacle Acetabular System Summary page 14 …N SERVICES Form Approved: OMB No. 0910-0120 Indications for Use See PRA Statement below. 510(k) Number (if known) K072963, K102423, K132959, K090998, K093646, K033273, K001534 Device Name PINNACLE ALTRX ACETABULAR LINERS, PINNACLE 100 GRIPTION CUPS, PINNACLE GRIPTION CUPS, PINNACLE ACETABULAR ENHANCED S…	DePuy Orthopaedics, Inc.	2000	—
*	K033338	Pinnacle Revision System Summary page 15 …Date: 06/30/2023 Indications for Use See PRA Statement below. 510(k) Number (if known) K033338, K192919, K040544, K951674, K961186, K994415, K010171, K863184, K221636 Device Name PINNACLE REVISION SYSTEM, PINNACLE DUOFIX HA…	DePuy Orthopaedics, Inc.	2004	—
*	K192919	Pinnacle Duofix HA Acetabular Cup Prosthesis Summary page 15 …/30/2023 Indications for Use See PRA Statement below. 510(k) Number (if known) K033338, K192919, K040544, K951674, K961186, K994415, K010171, K863184, K221636 Device Name PINNACLE REVISION SYSTEM, PINNACLE DUOFIX HA ACETABUL…	DePuy Orthopaedics, Inc.	2019	—
*	K040544	Duraloc Option Acetabular Cup System, Models 1599-01-044 to -066, 1599-11-044 to -062… Summary page 15 …Indications for Use See PRA Statement below. 510(k) Number (if known) K033338, K192919, K040544, K951674, K961186, K994415, K010171, K863184, K221636 Device Name PINNACLE REVISION SYSTEM, PINNACLE DUOFIX HA ACETABULAR CUP, D…	Depuy, Inc.	2004	—
*	K951674	Depuy Duraloc 100C Acetabular Cup Summary page 15 …Indications for Use See PRA Statement below. 510(k) Number (if known) K033338, K192919, K040544, K951674, K961186, K994415, K010171, K863184, K221636 Device Name PINNACLE REVISION SYSTEM, PINNACLE DUOFIX HA ACETABULAR CUP, DURALOC OP…	Depuy, Inc.	1995	—
*	K961186	Depuy Duraloc Cementless Acetabular Cup System Summary page 15 …Indications for Use See PRA Statement below. 510(k) Number (if known) K033338, K192919, K040544, K951674, K961186, K994415, K010171, K863184, K221636 Device Name PINNACLE REVISION SYSTEM, PINNACLE DUOFIX HA ACETABULAR CUP, DURALOC OPTION CUP…	Depuy, Inc.	1996	—
*	K994415	Marathon Cross-Linked Polyethylene Acetabular Cup Liners Summary page 15 …Indications for Use See PRA Statement below. 510(k) Number (if known) K033338, K192919, K040544, K951674, K961186, K994415, K010171, K863184, K221636 Device Name PINNACLE REVISION SYSTEM, PINNACLE DUOFIX HA ACETABULAR CUP, DURALOC OPTION CUP SYSTEM, D…	DePuy Orthopaedics, Inc.	2000	—
*	K010171	Duraloc Acetabular Cup System, 36MM Marathon +4 Polyethylene Liner Summary page 15 …ications for Use See PRA Statement below. 510(k) Number (if known) K033338, K192919, K040544, K951674, K961186, K994415, K010171, K863184, K221636 Device Name PINNACLE REVISION SYSTEM, PINNACLE DUOFIX HA ACETABULAR CUP, DURALOC OPTION CUP SYSTEM, DURALOC 10…	DePuy Orthopaedics, Inc.	2001	—
*	K863184	Profile Hip Acetabulum Prosthesis Summary page 15 …for Use See PRA Statement below. 510(k) Number (if known) K033338, K192919, K040544, K951674, K961186, K994415, K010171, K863184, K221636 Device Name PINNACLE REVISION SYSTEM, PINNACLE DUOFIX HA ACETABULAR CUP, DURALOC OPTION CUP SYSTEM, DURALOC 100C CUP, D…	Depuy, Inc.	1987	—
*	K221636	EMPHASYS Acetabular System Summary page 15 …See PRA Statement below. 510(k) Number (if known) K033338, K192919, K040544, K951674, K961186, K994415, K010171, K863184, K221636 Device Name PINNACLE REVISION SYSTEM, PINNACLE DUOFIX HA ACETABULAR CUP, DURALOC OPTION CUP SYSTEM, DURALOC 100C CUP, DURALOC CE…	Depuy Ireland UC	2022	—
*	K011533	Depuy Femoral Heads Summary page 17 …S Form Approved: OMB No. 0910-0120 Indications for Use See PRA Statement below. 510(k) Number (if known) K860701, K880269, K883460, K060031, K980513, K120599, K222296, K011533, K031803, K062748, K071830, K871867 Device Name HPS FEMORAL BALL HEADS, TOTAL HIP BALL FEMORAL HEADS, ARTICUL/EZE FEMORAL HEADS…	DePuy Orthopaedics, Inc.	2002	—
*	K031803	Depuy Ceramic Femoral Heads Summary page 17 …proved: OMB No. 0910-0120 Indications for Use See PRA Statement below. 510(k) Number (if known) K860701, K880269, K883460, K060031, K980513, K120599, K222296, K011533, K031803, K062748, K071830, K871867 Device Name HPS FEMORAL BALL HEADS, TOTAL HIP BALL FEMORAL HEADS, ARTICUL/EZE FEMORAL HEADS, MODULAR…	DePuy Orthopaedics, Inc.	2003	—
*	K062748	Modification: to Depuy Delta Ceramic Femoral Head Summary page 17 …MB No. 0910-0120 Indications for Use See PRA Statement below. 510(k) Number (if known) K860701, K880269, K883460, K060031, K980513, K120599, K222296, K011533, K031803, K062748, K071830, K871867 Device Name HPS FEMORAL BALL HEADS, TOTAL HIP BALL FEMORAL HEADS, ARTICUL/EZE FEMORAL HEADS, MODULAR M HEADS,…	DePuy Orthopaedics, Inc.	2006	—
*	K071830	Depuy Delta TS Ceramic Femoral Heads Summary page 17 …10-0120 Indications for Use See PRA Statement below. 510(k) Number (if known) K860701, K880269, K883460, K060031, K980513, K120599, K222296, K011533, K031803, K062748, K071830, K871867 Device Name HPS FEMORAL BALL HEADS, TOTAL HIP BALL FEMORAL HEADS, ARTICUL/EZE FEMORAL HEADS, MODULAR M HEADS, 36mm FEM…	DePuy Orthopaedics, Inc.	2007	1
*	K871867	Elite Modular Hip System Summary page 17 …Indications for Use See PRA Statement below. 510(k) Number (if known) K860701, K880269, K883460, K060031, K980513, K120599, K222296, K011533, K031803, K062748, K071830, K871867 Device Name HPS FEMORAL BALL HEADS, TOTAL HIP BALL FEMORAL HEADS, ARTICUL/EZE FEMORAL HEADS, MODULAR M HEADS, 36mm FEMORAL HEAD…	Thackray USA	1988	—
*	K812672	Self-Centering Hip Summary page 18 …SERVICES Form Approved: OMB No. 0910-0120 Food and Drug Administration Expiration Date: 06/30/2023 Indications for Use See PRA Statement below. 510(k) Number (if known) K812672 Device Name SELF-CENTERING HIP Indications for Use (Describe) Self-Centering hip arthroplasty is indicated in the following con…	Depuy, Inc.	1981	—
*	K860701	HPS II Smooth Stem Summary page 17 …3 of 27 DEPARTMENT OF HEALTH AND HUMAN SERVICES Form Approved: OMB No. 0910-0120 Indications for Use See PRA Statement below. 510(k) Number (if known) K860701, K880269, K883460, K060031, K980513, K120599, K222296, K011533, K031803, K062748, K071830, K871867 Device Name HPS FEMORAL BALL…	Depuy, Inc.	1986	—
*	K880269	LCS Femoral Hip Prosthesis Summary page 17 …DEPARTMENT OF HEALTH AND HUMAN SERVICES Form Approved: OMB No. 0910-0120 Indications for Use See PRA Statement below. 510(k) Number (if known) K860701, K880269, K883460, K060031, K980513, K120599, K222296, K011533, K031803, K062748, K071830, K871867 Device Name HPS FEMORAL BALL HEADS, T…	Depuy, Inc.	1988	—
*	K883460	Focus Total Hip System Summary page 17 …17 === DEPARTMENT OF HEALTH AND HUMAN SERVICES Form Approved: OMB No. 0910-0120 Indications for Use See PRA Statement below. 510(k) Number (if known) K860701, K880269, K883460, K060031, K980513, K120599, K222296, K011533, K031803, K062748, K071830, K871867 Device Name HPS FEMORAL BALL HEADS, TOTAL HIP…	Depuy, Inc.	1988	—
*	K060031	Depuy Modular M Heads Summary page 17 …PARTMENT OF HEALTH AND HUMAN SERVICES Form Approved: OMB No. 0910-0120 Indications for Use See PRA Statement below. 510(k) Number (if known) K860701, K880269, K883460, K060031, K980513, K120599, K222296, K011533, K031803, K062748, K071830, K871867 Device Name HPS FEMORAL BALL HEADS, TOTAL HIP BALL FEMO…	DePuy Orthopaedics, Inc.	2006	—
*	K980513	Articul/Eze Femoral Heads Summary page 17 …OF HEALTH AND HUMAN SERVICES Form Approved: OMB No. 0910-0120 Indications for Use See PRA Statement below. 510(k) Number (if known) K860701, K880269, K883460, K060031, K980513, K120599, K222296, K011533, K031803, K062748, K071830, K871867 Device Name HPS FEMORAL BALL HEADS, TOTAL HIP BALL FEMORAL HEADS…	DePuy Orthopaedics, Inc.	1998	—
*	K120599	Depuy M-Spec 36MM Femoral Heads Summary page 17 …AND HUMAN SERVICES Form Approved: OMB No. 0910-0120 Indications for Use See PRA Statement below. 510(k) Number (if known) K860701, K880269, K883460, K060031, K980513, K120599, K222296, K011533, K031803, K062748, K071830, K871867 Device Name HPS FEMORAL BALL HEADS, TOTAL HIP BALL FEMORAL HEADS, ARTICUL…	Depuy Orthopaedics	2013	—
*	K222296	ARTICUL/EZE Ceramic Heads Summary page 17 …N SERVICES Form Approved: OMB No. 0910-0120 Indications for Use See PRA Statement below. 510(k) Number (if known) K860701, K880269, K883460, K060031, K980513, K120599, K222296, K011533, K031803, K062748, K071830, K871867 Device Name HPS FEMORAL BALL HEADS, TOTAL HIP BALL FEMORAL HEADS, ARTICUL/EZE FEMO…	Depuy Ireland UC	2023	—
*	K920317	S-Rom LF Femoral Head Summary page 19 …DEPARTMENT OF HEALTH AND HUMAN SERVICES Form Approved: OMB No. 0910-0120 Indications for Use See PRA Statement below. 510(k) Number (if known) K851422/K920317 Device Name S-ROM FEMORAL HEADS Indications for Use (Describe) INDICATIONS — TOTAL HIP PROSTHESIS Total hip replacement is ind…	Joint Medical Products Corp.	1992	—
*	K861979	Aml II Titanium Acetabulum Prosthesis Summary page 21 …7 of 27 DEPARTMENT OF HEALTH AND HUMAN SERVICES Form Approved: OMB No. 0910-0120 Indications for Use See PRA Statement below. 510(k) Number (if known) K861979, K970929, K983014, K123924 Device Name DEPUY 5.0MM TAPERED HEAD PERIPHERAL SCREW, LOW PROFILE BONE SCREW, ACETABULAR SYSTEM SCR…	Depuy, Inc.	1987	—
*	K970929	Depuy Low Profile Bone Screw Summary page 21 …DEPARTMENT OF HEALTH AND HUMAN SERVICES Form Approved: OMB No. 0910-0120 Indications for Use See PRA Statement below. 510(k) Number (if known) K861979, K970929, K983014, K123924 Device Name DEPUY 5.0MM TAPERED HEAD PERIPHERAL SCREW, LOW PROFILE BONE SCREW, ACETABULAR SYSTEM SCREWS, GRIP…	Depuy, Inc.	1997	—
*	K983014	Summit Acetabular System Summary page 21 …21 === DEPARTMENT OF HEALTH AND HUMAN SERVICES Form Approved: OMB No. 0910-0120 Indications for Use See PRA Statement below. 510(k) Number (if known) K861979, K970929, K983014, K123924 Device Name DEPUY 5.0MM TAPERED HEAD PERIPHERAL SCREW, LOW PROFILE BONE SCREW, ACETABULAR SYSTEM SCREWS, GRIPTION TF 5…	Johnson & Johnson Professionals, Inc.	1998	—
*	K123924	Depuy Gription TF 5.5MM Sterile Locking Screws Summary page 21 …PARTMENT OF HEALTH AND HUMAN SERVICES Form Approved: OMB No. 0910-0120 Indications for Use See PRA Statement below. 510(k) Number (if known) K861979, K970929, K983014, K123924 Device Name DEPUY 5.0MM TAPERED HEAD PERIPHERAL SCREW, LOW PROFILE BONE SCREW, ACETABULAR SYSTEM SCREWS, GRIPTION TF 5.5mm LOCK…	Depuy Orthopaedics	2013	—
*	K100391	Depuy Universal Gription TF Cones Summary page 25 …1 of 27 DEPARTMENT OF HEALTH AND HUMAN SERVICES Form Approved: OMB No. 0910-0120 Indications for Use See PRA Statement below. 510(k) Number (if known) K100391 Device Name DEPUY GRIPTION TF CONES & HIP AUGMENTS Indications for Use (Describe) The DePuy Gription TF Acetabular Augments,…	DePuy Orthopaedics, Inc.	2010	—
*	K800894	Dupuy Cement Restrictor Trials & Instr. Summary page 27 …3 of 27 DEPARTMENT OF HEALTH AND HUMAN SERVICES Form Approved: OMB No. 0910-0120 Indications for Use See PRA Statement below. 510(k) Number (if known) K800894 Device Name DEPUY CEMENT RESTRICTOR Indications for Use (Describe) The UHMWPe cement restrictor is intended for use in cement…	Depuy, Inc.	1980	5
*	K871510	Modified Profile Hip Pmma Cement Spacer Summary page 28 …SERVICES Form Approved: OMB No. 0910-0120 Food and Drug Administration Expiration Date: 06/30/2023 Indications for Use See PRA Statement below. 510(k) Number (if known) K871510 Device Name DEPUY MODIFIED PROFILE HIP PMMA CEMENT SPACER Indications for Use (Describe) The Modified Profile Hip PMMA Spacer…	Depuy, Inc.	1987	—
*	K963309	Apex Hole Eliminator PS Summary page 23 …SERVICES Form Approved: OMB No. 0910-0120 Food and Drug Administration Expiration Date: 06/30/2023 Indications for Use See PRA Statement below. 510(k) Number (if known) K963309 Device Name DEPUY APEX HOLE ELIMINATOR PS Indications for Use (Describe) The Apex Hole Eliminator PS is a threaded plug inten…	Depuy, Inc.	1996	—
*	K971682	J-FX Cerclage System Summary page 24 …0 of 27 DEPARTMENT OF HEALTH AND HUMAN SERVICES Form Approved: OMB No. 0910-0120 Indications for Use See PRA Statement below. 510(k) Number (if known) K971682 Device Name DEPUY J-FX CERCLAGE SYSTEM Indications for Use (Describe) The J-Fx Cerclage System is indicated for use as a cerc…	Johnson & Johnson Professionals, Inc.	1997	—
*	K963206	S-Rom Hip System - Locking Plug Summary page 29 …5 of 27 DEPARTMENT OF HEALTH AND HUMAN SERVICES Form Approved: OMB No. 0910-0120 Indications for Use See PRA Statement below. 510(k) Number (if known) K963206, K951000 Device Name DEPUY S-ROM HIP SYSTEM LOCKING PLUG, S-ROM SCREWS Indications for Use (Describe) Total hip arthroplasty…	Johnson & Johnson Professionals, Inc.	1996	—
*	K951000	ZTT I and II Acetabular Cup of the S-Rom Total Hip System Summary page 29 …DEPARTMENT OF HEALTH AND HUMAN SERVICES Form Approved: OMB No. 0910-0120 Indications for Use See PRA Statement below. 510(k) Number (if known) K963206, K951000 Device Name DEPUY S-ROM HIP SYSTEM LOCKING PLUG, S-ROM SCREWS Indications for Use (Describe) Total hip arthroplasty is indica…	Joint Medical Products Corp.	1995	—

Also cleared against K102080: 2 other devices →

What descends from it? (5)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K251292	RECLAIM Monobloc Revision Femoral Stem	Depuy Ireland UC	2025	1
K243977	EMPHASYS Acetabular System	Depuy Ireland UC	2025	1
K242084	EMPHASYS Acetabular Shell with RapiTite HA	Depuy Ireland UC	2024	0

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 30 years and passes through 8 companies; a new generation was cleared every 1.7 years on median.
66 of the 285 ancestors have a recall of any class.
Of its descendants, K251292 (Depuy Ireland UC, 2025) has gone furthest, with 1 descendant of its own.
2 other devices also cite its predicate K102080.

How does its category compare?

All MEH devices

MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.

FDA decisions per year · MEH

5in 2025

2007high 6 (2008) · low 0 (2014)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MEH

87in 2025

2007high 226 (2010) · low 65 (2009)2026

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

Recalls per year · MEH

1in 2025

2007high 80 (2008) · low 0 (2013)2026

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

Adverse event reports per year · MEH

470in 2025

2007high 1,606 (2012) · low 25 (2007)2025

MAUDE reports naming product code MEH, 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	2	—	3	25
2008	6	79	80	261
2009	6	65	51	539
2010	5	226	16	462
2011	5	95	4	419
2012	6	131	3	1,606
2013	1	—	0	1,295
2014	0	—	1	1,196
2015	2	—	1	490
2016	6	163	4	347
2017	3	209	1	383
2018	2	—	3	337
2019	1	—	0	335
2020	3	131	1	338
2021	3	83	0	372
2022	3	150	0	316
2023	2	—	0	334
2024	6	91	0	354
2025	5	87	1	470
2026	1	—	1	—

What is it indicated for?

Total hip replacement is indicated in the following conditions: 1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia. 2. Avascular necrosis of the femoral head. 3. Acute traumatic fracture of the femoral head or neck. 4. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total…

Read the full statement (1,379 words)

Total hip replacement is indicated in the following conditions:

1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.

2. Avascular necrosis of the femoral head.

3. Acute traumatic fracture of the femoral head or neck.

4. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.

5. Certain cases of ankylosis.

Total hip replacement is indicated in the following conditions:

1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.

2. Avascular necrosis of the femoral head.

3. Acute traumatic fracture of the femoral head or neck.

4. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.

5. Certain cases of ankylosis.

The DePuy® C-Stem AMT Hip Stem is indicated for cemented use only.

HA-coated stems of the CORAIL Hip System are indicated for cementless use only.

The DePuy RECLAIM Revision Femoral Stem is indicated for cementless use in the treatment of failed previous hip surgery, including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or other total hip replacement.

Total hip replacement is indicated in the following conditions:

1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.

2. Avascular necrosis of the femoral head.

3. Acute traumatic fracture of the femoral head or neck.

4. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.

5. Certain cases of ankylosis.

The Solution Hip Stem is indicated for cementless use and fixation by biological tissue ingrowth into the porous coating as well as cemented use and fixation in which the porous coating serves as a means to augment the fixation of the prosthesis to the bone cement.

Total hip replacement is indicated in the following conditions:

1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.

2. Avascular necrosis of the femoral head.

3. Acute traumatic fracture of the femoral head or neck.

4. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.

5. Certain cases of ankylosis.

Hemi hip replacement is indicated in the following conditions:

1. Acute fracture of the femoral head or neck that cannot be appropriately reduced and treated with internal fixation.

2. Fracture dislocation of the hip that cannot be appropriately reduced and treated with internal fixation.

3. Avascular necrosis of the femoral head.

4. Non-union of femoral neck fractures.

5. Certain high subcapital and femoral neck fractures in the elderly.

6. Degenerative arthritis involving only the femoral head in which the acetabulum does not require replacement.

7. Pathology involving only the femoral head/neck and/or proximal femur that can be adequately treated by hemi-hip arthroplasty.

Total hip replacement is indicated in the following conditions:

1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.

2. Avascular necrosis of the femoral head.

3. Acute traumatic fracture of the femoral head or neck.

4. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.

5. Certain cases of ankylosis.

Total hip replacement or hip arthroplasty is indicated in the following conditions:

1. A severely painful and/or disabled joint (typically due to non inflammatory degenerative joint disease).

2. Failed previous hip surgery.

3. Dislocation risks.

PINNACLE Dual Mobility Metal Liners and Porous-coated PINNACLE Acetabular Cups are intended for cementless applications.

Total hip replacement is indicated in the following conditions:

1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.

2. Avascular necrosis of the femoral head.

3. Acute traumatic fracture of the femoral head or neck.

4. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.

5. Certain cases of ankylosis.

Total hip replacement is indicated in the following conditions:

1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.

2. Avascular necrosis of the femoral head.

3. Acute traumatic fracture of the femoral head or neck.

4. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.

5. Certain cases of ankylosis.

Total hip replacement is indicated in the following conditions:

1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.

2. Avascular necrosis of the femoral head.

3. Acute traumatic fracture of the femoral head or neck.

4. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.

5. Certain cases of ankylosis.

INDICATIONS — TOTAL HIP PROSTHESIS

Total hip replacement is indicated in the following conditions:

1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.

2. Avascular necrosis of the femoral head.

3. Acute traumatic fracture of the femoral head or neck.

4. Certain cases of ankylosis.

INDICATIONS — HEMI-HIP PROSTHESIS

Hemi-hip arthroplasty is indicated in the following conditions:

1. Acute fracture of the femoral head or neck that cannot be appropriately reduced and treated with internal fixation.

2. Fracture dislocation of the hip that cannot be appropriately reduced and treated with internal fixation.

3. Avascular necrosis of the femoral head.

4. Non-union of femoral neck fractures.

5. Certain high subcapital and femoral neck fractures in the elderly.

6. Degenerative arthritis involving only the femoral head in which the acetabulum does not require replacement.

7. Pathology involving only the femoral head/neck and/or proximal femur that can be adequately treated by hemi-hip arthroplasty.

The DePuy Screws are indicated for use in primary or revision hip surgery for total hip replacement in the following conditions:

1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.

2. Avascular necrosis of the femoral head.

3. Acute traumatic fracture of the femoral head or neck.

4. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.

5. Certain cases of ankylosis.

The Apex Hole Eliminator PS is a threaded plug intended to close the apical hole of the Duraloc series two-piece (metal shell and UHMWPe liner) acetabular cups. It is intended for use in Duraloc cups implanted with or without bone cement.

The J-Fx Cerclage System is indicated for use as a cerclage fixation device in general orthopaedic repairs. These include procedures such as: reinforcement of bone; reattachment of the greater trochanter; fixation of long bone fractures with grafting; and fixation of patellar fractures.

The DePuy Gription TF Acetabular Augments, Buttresses and Shims are indicated for use in total hip replacement in the following conditions:

1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.

2. Avascular necrosis of the femoral head.

3. Acute traumatic fracture of the femoral head or neck.

4. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.

5. Certain cases of ankylosis.

The porous Gription TF titanium acetabular augment is affixed to the mating acetabular cup using bone cement or mechanical screw fixation. The assembled porous titanium augment is intended for cemented or cementless use.

The porous Gription TF titanium shim is affixed to the mating buttress using bone cement. This porous Gription TF titanium buttress is affixed to the mating acetabular cup using bone cement. The assembled buttress/acetabular cup construct is intended for cemented or cementless use.

The UHMWPe cement restrictor is intended for use in cemented total and hemiarthroplasty procedures to restrict distal flow of bone cement in the femoral medullary cavity.

The Modified Profile Hip PMMA Spacer is indicated for use in cemented hip replacement.

Total hip arthroplasty is indicated for total hip replacement in the following conditions:

1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.

2. Avascular necrosis of the femoral head.

3. Acute traumatic fracture of the femoral head or neck.

4. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.

5. Certain cases of ankylosis.

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/K231873 · printed Nov 6, 2026

Cite this page

510(k) Report. “K231873: DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip Prosthesis – MR Conditional, DePuy SUMMIT Cemented Hip Prosthesis – MR Conditional, DePuy SUMMIT FX Cemented Hip Prosthesis – MR Conditional, DePuy SUMMIT Basic Press-Fit Hip Prosthesis – MR Conditional.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231873

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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

DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip Prosthesis – MR Conditional, DePuy SUMMIT Cemented Hip Prosthesis – MR Conditional, DePuy SUMMIT FX Cemented Hip Prosthesis – MR Conditional, DePuy SUMMIT Basic Press-Fit Hip Prosthesis – MR Conditional

Line of descent and top descendants

Other ancestors by year cleared

Descendants by year cleared

What was it cleared against? (71)

What descends from it? (5)

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

What does this lineage say?

How does its category compare?

What is it indicated for?

Also cleared against K102080

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