510(k) · Cleared

Cleared

Porocoat Porous Coating

K931641510(k) TraditionalCleared Mar 21, 1994353-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 Mar 21, 1994 after a 353-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 173 later devices descend from it.

Decided: Mar 21, 1994
Review: 353 days
Class: Class II
Product code: LPH
Recalls: None
Predicates: 0

173 later devices descend from it, 5 citing it directly.

This deviceK931641 Porocoat Porous CoatingDepuy, Inc. · 1994
Descendant · cites it directly · 159 of its ownK003800 Aml Hip ProsthesisDePuy Orthopaedics, Inc. · 2001
Descendant · cites it directly · 158 of its ownK012364 Aml Hip ProsthesisDePuy Orthopaedics, Inc. · 2001
Descendant · 2 generations on · 146 of its ownK030236 Acumatch P-Series Porous Press-Fit Femoral ComponentExactech, Inc. · 2003
Descendant · 3 generations on · 145 of its ownK041906 Exactech 12/14 Total Hip SystemExactech, Inc. · 2004 · Recalled
Descendant · 4 generations on · 64 of its ownK042842 Novation 12/14 Press-Fit Femoral StemExactech, Inc. · 2004

Showing 5 of 173 descendants. See all descendants

Descendants cleared per year

1997high 15 (2025) · low 0 (1998)2026

Most influential descendants

Showing 5 of 173 · See all

K003800Aml Hip ProsthesisDePuy Orthopaedics, Inc. · 2001 · cites it directly159descendants
K012364Aml Hip ProsthesisDePuy Orthopaedics, Inc. · 2001 · cites it directly158descendants
K030236Acumatch P-Series Porous Press-Fit Femoral ComponentExactech, Inc. · 2003 · 2 generations on146descendants
K041906Exactech 12/14 Total Hip SystemExactech, Inc. · 2004 · 3 generations on145descendants
K042842Novation 12/14 Press-Fit Femoral StemExactech, Inc. · 2004 · 4 generations on64descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K931641	Porocoat Porous Coating	Depuy, Inc.	1994	—
+1	K003800	Aml Hip Prosthesis	DePuy Orthopaedics, Inc.	2001	—
+1	K012364	Aml Hip Prosthesis	DePuy Orthopaedics, Inc.	2001	—
+2	K030236	Acumatch P-Series Porous Press-Fit Femoral Component	Exactech, Inc.	2003	—
+3	K041906	Exactech 12/14 Total Hip System	Exactech, Inc.	2004	1
+4	K042842	Novation 12/14 Press-Fit Femoral Stem	Exactech, Inc.	2004	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0
2000	1	0
2001	2	0
2002	1	0
2003	4	0
2004	3	0
2005	2	0
2006	6	0
2007	1	0
2008	3	0
2009	1	0
2010	6	0
2012	6	0
2013	5	0
2014	8	0
2015	5	0
2016	6	0
2017	8	0
2018	7	0
2019	14	0
2020	8	0
2021	7	0
2022	12	0
2023	13	0
2024	14	0
2025	15	0
2026	14	0

FIG. 1 — Lineage of K931641, 1994–2026Source: 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 24.3 · 20 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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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? (173)

See all 173

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

Number	Device	Applicant	Decided	Descendants
K003800	Aml Hip Prosthesis	DePuy Orthopaedics, Inc.	2001	159
K012364	Aml Hip Prosthesis	DePuy Orthopaedics, Inc.	2001	158
K973714	Versys Hip System Beaded Hip Prosthesis	Zimmer, Inc.	1997	18
K014070	Epoch Hip Prosthesis, Model 4075 Series	Zimmer, Inc.	2002	2
K000207	Porocoat Prodigy Hip Prosthesis	DePuy Orthopaedics, Inc.	2000	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?

Of its descendants, K003800 (DePuy Orthopaedics, Inc., 2001) has gone furthest, with 159 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/K931641 · printed Nov 4, 2026

Cite this page

510(k) Report. “K931641: Porocoat Porous Coating.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K931641

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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