510(k) · Cleared

Cleared

Depuy Corail Hip System, Revision Stem

K093736510(k) TraditionalCleared Mar 10, 2011461-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 Orthopaedics, Inc. · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Cleared on Mar 10, 2011 as substantially equivalent to K042992 (DePuy Orthopaedics, Inc., 2005) and 1 other predicate after a 461-day review. Its family tree reaches back 6 generations to 1994. 14 later devices descend from it.

Decided: Mar 10, 2011
Review: 461 days
Class: Class II
Product code: LZO
Recalls: None
Predicates: 2

Its longest line of descent runs back 6 generations to K935452 (1994). 17 ancestors in all, the oldest K851422 (1985). 14 later devices descend from it, 5 citing it directly.

By dateBy generation

Root · 6 generations backK935452 P.F.C. 2 Total Hip System Porous Coated Modular Femoral ComponentJohnson & Johnson Orthopaedics, Inc. · 1994
5 generations backK945518 P.F.C. 2 Total Hip System Porous Coated Modular Femoral ComponentJohnson & Johnson Professionals, Inc. · 1996
4 generations backK961939 S-Rom Femoral Hip Stem (Sizes 12 X 06 X 115 and 12 X 07 X 115)Johnson & Johnson Professionals, Inc. · 1996
3 generations backK974331 Uni-Rom Total Hip System Femoral StemJohnson & Johnson Professionals, Inc. · 1998
2 generations backK001991 Titan Porocoat Hip ProsthesisDePuy Orthopaedics, Inc. · 2000
1 generation backK042992 Corail Amt Hip ProsthesisDePuy Orthopaedics, Inc. · 2005 · Recalled
This deviceK093736 Depuy Corail Hip System, Revision StemDePuy Orthopaedics, Inc. · 2011
Descendant · cites it directly · 10 of its ownK192946 DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc. · 2019
Descendant · 2 generations on · 7 of its ownK211657 EMPHASYS Femoral StemsDepuy Ireland UC · 2021
Descendant · cites it directly · 5 of its ownK231873 DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT…Depuy Ireland UC · 2024
Descendant · cites it directly · 2 of its ownK203167 DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc. · 2020
Descendant · cites it directly · 2 of its ownK171249 Entrada™ hip stemOrtho Development Corporation · 2017

Showing 5 of 14 descendants. See all descendants

Descendants cleared per year

2017high 4 (2025) · low 0 (2018)2026

Most influential descendants

Showing 5 of 14 · See all

K192946DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc. · 2019 · cites it directly10descendants
K211657EMPHASYS Femoral StemsDepuy Ireland UC · 2021 · 2 generations on7descendants
K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…Depuy Ireland UC · 2024 · cites it directly5descendants
K203167DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc. · 2020 · cites it directly2descendants
K171249Entrada™ hip stemOrtho Development Corporation · 2017 · cites it directly2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−6	K935452	P.F.C. 2 Total Hip System Porous Coated Modular Femoral Component	Johnson & Johnson Orthopaedics, Inc.	1994	—
−5	K945518	P.F.C. 2 Total Hip System Porous Coated Modular Femoral Component	Johnson & Johnson Professionals, Inc.	1996	—
−4	K961939	S-Rom Femoral Hip Stem (Sizes 12 X 06 X 115 and 12 X 07 X 115)	Johnson & Johnson Professionals, Inc.	1996	—
−3	K974331	Uni-Rom Total Hip System Femoral Stem	Johnson & Johnson Professionals, Inc.	1998	—
−2	K001991	Titan Porocoat Hip Prosthesis	DePuy Orthopaedics, Inc.	2000	—
−1	K042992	Corail Amt Hip Prosthesis	DePuy Orthopaedics, Inc.	2005	1
0 (this device)	K093736	Depuy Corail Hip System, Revision Stem	DePuy Orthopaedics, Inc.	2011	—
+1	K192946	DePuy Corail AMT Hip Prosthesis	DePuy Orthopaedics, Inc.	2019	—
+2	K211657	EMPHASYS Femoral Stems	Depuy Ireland UC	2021	—
+1	K231873	DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…	Depuy Ireland UC	2024	—
+1	K203167	DePuy Corail AMT Hip Prosthesis	DePuy Orthopaedics, Inc.	2020	—
+1	K171249	Entrada™ hip stem	Ortho Development Corporation	2017	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1985	1	0
1991	1	0
1992	2	0
1993	1	0
1994	2	0
1996	3	0
1997	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2017	1	0
2019	1	0
2020	1	0
2021	1	0
2022	1	0
2023	1	0
2024	3	0
2025	4	0
2026	1	0

FIG. 1 — Lineage of K093736, 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 LZO? 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 LZO device

#1 K192827 Quadra-Pscore 19.3 · 10 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? (2)

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
*	K042992	Corail Amt Hip Prosthesis Summary page 2 …hip, semi-constrained, metal/polymer, uncemented SUBSTANTIALLY EQUIVALENT DePuy Corail Hip Stem, K042992 DEVICES: DePuy KART M Hip Stem, K961732 DEVICE DESCRIPTION: The Corail Revision Stem is part of…	DePuy Orthopaedics, Inc.	2005	1
*	K961732	KAR Summary page 2 …mer, uncemented SUBSTANTIALLY EQUIVALENT DePuy Corail Hip Stem, K042992 DEVICES: DePuy KART M Hip Stem, K961732 DEVICE DESCRIPTION: The Corail Revision Stem is part of a modular prosthesis system for use in total hip replacement. It mates w…	Landos, Inc.	1997	—

Also cleared against K042992: 26 other devices →

What descends from it? (14)

See all 14

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

Number	Device	Applicant	Decided	Descendants
K192946	DePuy Corail AMT Hip Prosthesis	DePuy Orthopaedics, Inc.	2019	10
K231873	DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…	Depuy Ireland UC	2024	5
K203167	DePuy Corail AMT Hip Prosthesis	DePuy Orthopaedics, Inc.	2020	2
K171249	Entrada™ hip stem	Ortho Development Corporation	2017	2
K213839	DePuy Corail AMT Hip Prosthesis	DePuy Orthopaedics, Inc.	2022	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 17 years and passes through 3 companies; a new generation was cleared every 2.5 years on median.
1 of the 17 ancestors has a recall of any class.
Of its descendants, K192946 (DePuy Orthopaedics, Inc., 2019) has gone furthest, with 10 descendants of its own.
26 other devices also cite its predicate K042992.

How does its category compare?

All LZO devices

LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · LZO

14in 2025

2007high 28 (2019) · low 7 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LZO

119in 2025

2007high 279 (2022) · low 63 (2008)2026

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

Recalls per year · LZO

1in 2025

2007high 42 (2009) · low 0 (2010)2026

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

Adverse event reports per year · LZO

3,244in 2025

2007high 3,244 (2025) · low 125 (2008)2025

MAUDE reports naming product code LZO, 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	9	87	2	138
2008	11	63	13	125
2009	7	83	42	189
2010	15	78	0	394
2011	13	87	10	544
2012	14	98	14	963
2013	26	100	0	1,370
2014	13	85	1	1,477
2015	12	115	1	1,348
2016	10	177	9	1,728
2017	16	257	5	2,165
2018	18	163	2	3,133
2019	28	109	4	3,066
2020	18	112	3	1,963
2021	12	170	0	2,199
2022	11	279	4	1,985
2023	10	122	2	2,066
2024	11	111	1	2,586
2025	14	119	1	3,244
2026	9	102	0	—

What is it indicated for?

The DePuy Corail Revision Stem is indicated for cementless use in the treatment of:

1. A severely painful and/or a severely disabled joint resulting from osteoarthritis, traumatic arthritis, or 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 arthoplasty, or other total hip replacement; and

5. Certain cases of ankylosis.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K093736 · printed Nov 6, 2026

Cite this page

510(k) Report. “K093736: Depuy Corail Hip System, Revision Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093736

Report an extraction error

Are you the manufacturer?

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