510(k) · Cleared

Cleared

DePuy Corail AMT Hip Prosthesis

K173960510(k) TraditionalCleared Sep 21, 2018267-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 France S.A.S. · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Cleared on Sep 21, 2018 as substantially equivalent to K123991 (Depuy France S.A.S., 2013) after a 267-day review. Its family tree reaches back 14 generations to 1994. 14 later devices descend from it.

Decided: Sep 21, 2018
Review: 267 days
Class: Class II
Product code: LZO
Recalls: None
Predicates: 1

Its longest line of descent runs back 14 generations to K941847 (1994). 174 ancestors in all, the oldest K810258 (1981). 14 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 14 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
10 generations between
3 generations backK111193 Apex Arc Hip StemOmni Life Science, Inc. · 2011
2 generations backK113242 Apex Arc Hip StemOmni Life Science, Inc. · 2012
1 generation backK123991 Depuy Corail Amt Hip ProsthesisDepuy France S.A.S. · 2013 · Recalled
This deviceK173960 DePuy Corail AMT Hip ProsthesisDepuy France S.A.S. · 2018
Descendant · cites it directly · 11 of its ownK190344 DePuy Corail AMT Hip ProsthesisDepuy (Ireland) · 2019
Descendant · cites it directly · 10 of its ownK192946 DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc. · 2019
Descendant · cites it directly · 7 of its ownK211657 EMPHASYS Femoral StemsDepuy Ireland UC · 2021
Descendant · 2 generations on · 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

Show all 14 generations

Root · 14 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
13 generations backK964650 TCP-Coated Porocoat Aml Femoral Hip ProsthesisDepuy, Inc. · 1997
12 generations backK980711 Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic…Zimmer, Inc. · 1998 · Recalled
11 generations backK001277 Triflange Acetabular Cup SystemDePuy Orthopaedics, Inc. · 2000
10 generations backK031495 Pinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc. · 2003
9 generations backK042344 Excia Total Hip SystemAesculap, Inc. · 2005 · Recalled
8 generations backK060918 Excia Total Hip System 12/14 Trunnion with Ceramic HeadAesculap, Inc. · 2006
7 generations backK062684 Excia Total Hip System 36MM Ceramic HeadAesculap, Inc. · 2006
6 generations backK082991 Biolox Delta Ceramic Femoral HeadAesculap Implant Systems, Inc. · 2008
5 generations backK083495 Modification to: Metha Hip SystemAesculap Implant Systems, Inc. · 2009
4 generations backK090845 Apex Arc Hip StemOmni Life Science, Inc. · 2010 · Recalled
3 generations backK111193 Apex Arc Hip StemOmni Life Science, Inc. · 2011
2 generations backK113242 Apex Arc Hip StemOmni Life Science, Inc. · 2012
1 generation backK123991 Depuy Corail Amt Hip ProsthesisDepuy France S.A.S. · 2013 · Recalled
This deviceK173960 DePuy Corail AMT Hip ProsthesisDepuy France S.A.S. · 2018

Showing 5 of 14 descendants. See all descendants

Descendants cleared per year

2019high 4 (2025) · low 1 (2020)2026

Most influential descendants

Showing 5 of 14 · See all

K190344DePuy Corail AMT Hip ProsthesisDepuy (Ireland) · 2019 · cites it directly11descendants
K192946DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc. · 2019 · cites it directly10descendants
K211657EMPHASYS Femoral StemsDepuy Ireland UC · 2021 · cites it directly7descendants
K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…Depuy Ireland UC · 2024 · 2 generations on5descendants
K203167DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc. · 2020 · cites it directly2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−14	K941847	5/8 Porocoat Aml Hip Porocoat Porous Coating	Depuy, Inc.	1994	—
−13	K964650	TCP-Coated Porocoat Aml Femoral Hip Prosthesis	Depuy, Inc.	1997	—
−12	K980711	Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic Coating	Zimmer, Inc.	1998	1
−11	K001277	Triflange Acetabular Cup System	DePuy Orthopaedics, Inc.	2000	—
−10	K031495	Pinnacle Duofix HA Acetabular Cup Prosthesis	DePuy Orthopaedics, Inc.	2003	—
−9	K042344	Excia Total Hip System	Aesculap, Inc.	2005	10
−8	K060918	Excia Total Hip System 12/14 Trunnion with Ceramic Head	Aesculap, Inc.	2006	—
−7	K062684	Excia Total Hip System 36MM Ceramic Head	Aesculap, Inc.	2006	—
−6	K082991	Biolox Delta Ceramic Femoral Head	Aesculap Implant Systems, Inc.	2008	—
−5	K083495	Modification to: Metha Hip System	Aesculap Implant Systems, Inc.	2009	—
−4	K090845	Apex Arc Hip Stem	Omni Life Science, Inc.	2010	2
−3	K111193	Apex Arc Hip Stem	Omni Life Science, Inc.	2011	—
−2	K113242	Apex Arc Hip Stem	Omni Life Science, Inc.	2012	—
−1	K123991	Depuy Corail Amt Hip Prosthesis	Depuy France S.A.S.	2013	1
0 (this device)	K173960	DePuy Corail AMT Hip Prosthesis	Depuy France S.A.S.	2018	—
+1	K190344	DePuy Corail AMT Hip Prosthesis	Depuy (Ireland)	2019	—
+1	K192946	DePuy Corail AMT Hip Prosthesis	DePuy Orthopaedics, Inc.	2019	—
+1	K211657	EMPHASYS Femoral Stems	Depuy Ireland UC	2021	—
+2	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	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1981	1	0
1984	1	0
1985	2	0
1987	2	0
1990	2	0
1991	5	0
1992	5	0
1993	4	0
1994	19	0
1995	12	0
1996	12	0
1997	7	0
1998	7	0
1999	5	0
2000	18	0
2001	9	0
2002	10	0
2003	7	0
2004	7	0
2005	6	0
2006	3	0
2007	3	0
2008	3	0
2009	2	0
2010	3	0
2011	3	0
2012	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2019	2	0
2020	1	0
2021	1	0
2022	1	0
2023	2	0
2024	2	0
2025	4	0
2026	1	0

FIG. 1 — Lineage of K173960, 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? (1)

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
*	K123991	Depuy Corail Amt Hip Prosthesis Summary page 4 …ation 21 CFR 888., 888.3360, 888.3390 Product Code(s) LZO, MEH, KWL, KWY Legally marketed DePuy Corail AMT Hip Prosthesis (K123991, cleared September 16, 2013) device(s) to which equivalence is claimed Reason for 510(k) Line extension – The subject…	Depuy France S.A.S.	2013	1
†	K093736	Depuy Corail Hip System, Revision Stem	DePuy Orthopaedics, Inc.	2011	—

Also cleared against K123991: 10 other devices →

What descends from it? (14)

See all 14

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

Number	Device	Applicant	Decided	Descendants
K190344	DePuy Corail AMT Hip Prosthesis	Depuy (Ireland)	2019	11
K192946	DePuy Corail AMT Hip Prosthesis	DePuy Orthopaedics, Inc.	2019	10
K211657	EMPHASYS Femoral Stems	Depuy Ireland UC	2021	7
K203167	DePuy Corail AMT Hip Prosthesis	DePuy Orthopaedics, Inc.	2020	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 24 years and passes through 7 companies; a new generation was cleared every 1.6 years on median.
43 of the 173 ancestors have a recall of any class.
Of its descendants, K190344 (Depuy (Ireland), 2019) has gone furthest, with 11 descendants of its own.
10 other devices also cite its predicate K123991.

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. 2018, 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?

Total hip replacement or hip arthroplasty 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, hemi-arthroplasty, surface replacement…

Read the full statement (189 words)

Total hip replacement or hip arthroplasty 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, hemi-arthroplasty, surface replacement arthroplasty, or total hip replacement.

5. Certain cases of ankyloses.

Partial hip replacement or hip hemi-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 hip hemi-arthroplasty.

HA coated stems of the Corail Hip system are indicated for cementless use only.

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/K173960 · printed Nov 6, 2026

Cite this page

510(k) Report. “K173960: DePuy Corail AMT Hip Prosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173960

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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