510(k) · Cleared

Cleared

Depuy Duraloc 400 Acetabular Cup

K952740510(k) TraditionalCleared Aug 18, 199564-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

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

Cleared on Aug 18, 1995 after a 64-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 214 later devices descend from it.

Decided: Aug 18, 1995
Review: 64 days
Class: Class II
Product code: LPH
Recalls: None
Predicates: 0

214 later devices descend from it, 1 citing it directly.

This deviceK952740 Depuy Duraloc 400 Acetabular CupDepuy, Inc. · 1995
Descendant · cites it directly · 213 of its ownK001277 Triflange Acetabular Cup SystemDePuy Orthopaedics, Inc. · 2000
Descendant · 2 generations on · 207 of its ownK031495 Pinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc. · 2003
Descendant · 3 generations on · 198 of its ownK042344 Excia Total Hip SystemAesculap, Inc. · 2005 · Recalled
Descendant · 4 generations on · 90 of its ownK060918 Excia Total Hip System 12/14 Trunnion with Ceramic HeadAesculap, Inc. · 2006
Descendant · 4 generations on · 90 of its ownK060437 Excia Total Hip System with U-CapAesculap, Inc. · 2006

Showing 5 of 214 descendants. See all descendants

Descendants cleared per year

2000high 19 (2025) · low 0 (2002)2026

Most influential descendants

Showing 5 of 214 · See all

K001277Triflange Acetabular Cup SystemDePuy Orthopaedics, Inc. · 2000 · cites it directly213descendants
K031495Pinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc. · 2003 · 2 generations on207descendants
K042344Excia Total Hip SystemAesculap, Inc. · 2005 · 3 generations on198descendants
K060918Excia Total Hip System 12/14 Trunnion with Ceramic HeadAesculap, Inc. · 2006 · 4 generations on90descendants
K060437Excia Total Hip System with U-CapAesculap, Inc. · 2006 · 4 generations on90descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K952740	Depuy Duraloc 400 Acetabular Cup	Depuy, Inc.	1995	—
+1	K001277	Triflange Acetabular Cup System	DePuy Orthopaedics, Inc.	2000	—
+2	K031495	Pinnacle Duofix HA Acetabular Cup Prosthesis	DePuy Orthopaedics, Inc.	2003	—
+3	K042344	Excia Total Hip System	Aesculap, Inc.	2005	10
+4	K060918	Excia Total Hip System 12/14 Trunnion with Ceramic Head	Aesculap, Inc.	2006	—
+4	K060437	Excia Total Hip System with U-Cap	Aesculap, Inc.	2006	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2000	1	0
2001	1	0
2003	1	0
2004	1	0
2005	1	0
2006	5	0
2007	1	0
2008	6	0
2009	5	0
2010	5	0
2011	12	0
2012	16	0
2013	12	0
2014	6	0
2015	6	0
2016	5	0
2017	12	0
2018	9	0
2019	6	0
2020	9	0
2021	17	0
2022	14	0
2023	16	0
2024	11	0
2025	19	0
2026	17	0

FIG. 1 — Lineage of K952740, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (214)

See all 214

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

Number	Device	Applicant	Decided	Descendants
K001277	Triflange Acetabular Cup System	DePuy Orthopaedics, Inc.	2000	213

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?

Of its descendants, K001277 (DePuy Orthopaedics, Inc., 2000) has gone furthest, with 213 descendants of its own.

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.

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	—

https://510kreport.com/device/K952740 · printed Nov 6, 2026

Cite this page

510(k) Report. “K952740: Depuy Duraloc 400 Acetabular Cup.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K952740

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026