510(k) · Cleared

Cleared

5/8 Porocoat Aml Hip Porocoat Porous Coating

K941847510(k) TraditionalCleared Jul 12, 199489-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, Inc. · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Cleared on Jul 12, 1994 after an 89-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 312 later devices descend from it.

Decided: Jul 12, 1994
Review: 89 days
Class: Class II
Product code: LZO
Recalls: None
Predicates: 0

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

This deviceK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
Descendant · cites it directly · 311 of its ownK964650 TCP-Coated Porocoat Aml Femoral Hip ProsthesisDepuy, Inc. · 1997
Descendant · 2 generations on · 309 of its ownK980711 Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic…Zimmer, Inc. · 1998 · Recalled
Descendant · 3 generations on · 296 of its ownK030733 Mayo Conservative Hip Prosthesis, Model 8026 SeriesZimmer, Inc. · 2003 · Recalled
Descendant · 4 generations on · 267 of its ownK040191 Bicontact Hip Stem and Femoral HeadAesculap · 2004
Descendant · 3 generations on · 213 of its ownK001277 Triflange Acetabular Cup SystemDePuy Orthopaedics, Inc. · 2000

Showing 5 of 312 descendants. See all descendants

Descendants cleared per year

1997high 26 (2012) · low 0 (2002)2026

Most influential descendants

Showing 5 of 312 · See all

K964650TCP-Coated Porocoat Aml Femoral Hip ProsthesisDepuy, Inc. · 1997 · cites it directly311descendants
K980711Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic CoatingZimmer, Inc. · 1998 · 2 generations on309descendants
K030733Mayo Conservative Hip Prosthesis, Model 8026 SeriesZimmer, Inc. · 2003 · 3 generations on296descendants
K040191Bicontact Hip Stem and Femoral HeadAesculap · 2004 · 4 generations on267descendants
K001277Triflange Acetabular Cup SystemDePuy Orthopaedics, Inc. · 2000 · 3 generations on213descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K941847	5/8 Porocoat Aml Hip Porocoat Porous Coating	Depuy, Inc.	1994	—
+1	K964650	TCP-Coated Porocoat Aml Femoral Hip Prosthesis	Depuy, Inc.	1997	—
+2	K980711	Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic Coating	Zimmer, Inc.	1998	1
+3	K030733	Mayo Conservative Hip Prosthesis, Model 8026 Series	Zimmer, Inc.	2003	2
+4	K040191	Bicontact Hip Stem and Femoral Head	Aesculap	2004	—
+3	K001277	Triflange Acetabular Cup System	DePuy Orthopaedics, Inc.	2000	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0
1998	1	0
1999	1	0
2000	1	0
2001	1	0
2003	2	0
2004	3	0
2005	1	0
2006	6	0
2007	1	0
2008	9	0
2009	5	0
2010	7	0
2011	16	0
2012	26	0
2013	23	0
2014	8	0
2015	9	0
2016	11	0
2017	17	0
2018	17	0
2019	15	0
2020	16	0
2021	19	0
2022	18	0
2023	20	0
2024	16	0
2025	22	0
2026	20	0

FIG. 1 — Lineage of K941847, 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 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

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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? (312)

See all 312

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

Number	Device	Applicant	Decided	Descendants
K964650	TCP-Coated Porocoat Aml Femoral Hip Prosthesis	Depuy, Inc.	1997	311

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, K964650 (Depuy, Inc., 1997) has gone furthest, with 311 descendants of its own.

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.

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	—

https://510kreport.com/device/K941847 · printed Nov 6, 2026

Cite this page

510(k) Report. “K941847: 5/8 Porocoat Aml Hip Porocoat Porous Coating.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K941847

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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