510(k) · Cleared

Recalled · 2011

P.F.C.(TM) Modular Knee System

K884796510(k) TraditionalCleared Mar 29, 1989133-day reviewClass II21 CFR 888.3560Recalls 16

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Johnson & Johnson Professionals, Inc. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Cleared on Mar 29, 1989 after a 133-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 19 later devices descend from it. It has been recalled 16 times.

Decided: Mar 29, 1989
Review: 133 days
Class: Class II
Product code: JWH
Recalls: 16
Predicates: 0

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

This deviceK884796 P.F.C.(TM) Modular Knee SystemJohnson & Johnson Professionals, Inc. · 1989
Descendant · cites it directly · 9 of its ownK954818 Consensus Posterior Stabilized KneeU.S. Medical Products, Inc. · 1996
Descendant · cites it directly · 7 of its ownK984158 P.F.C. Modular Plus Offset Tibial TrayDepuy, Inc. · 1999
Descendant · 2 generations on · 3 of its ownK163167 CKS Plus Knee SystemConsensus Orthopedics, Inc. · 2017
Descendant · 2 generations on · 3 of its ownK013906 HLS Noetos SystemTornier · 2002
Descendant · 3 generations on · 2 of its ownK191765 OMNI TiN Coated Apex Knee™ SystemOmni Life Science, Inc. · 2019

Showing 5 of 19 descendants. See all descendants

Descendants cleared per year

1996high 2 (2011) · low 0 (1997)2026

Most influential descendants

Showing 5 of 19 · See all

K954818Consensus Posterior Stabilized KneeU.S. Medical Products, Inc. · 1996 · cites it directly9descendants
K984158P.F.C. Modular Plus Offset Tibial TrayDepuy, Inc. · 1999 · cites it directly7descendants
K163167CKS Plus Knee SystemConsensus Orthopedics, Inc. · 2017 · 2 generations on3descendants
K013906HLS Noetos SystemTornier · 2002 · 2 generations on3descendants
K191765OMNI TiN Coated Apex Knee™ SystemOmni Life Science, Inc. · 2019 · 3 generations on2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K884796	P.F.C.(TM) Modular Knee System	Johnson & Johnson Professionals, Inc.	1989	—
+1	K954818	Consensus Posterior Stabilized Knee	U.S. Medical Products, Inc.	1996	—
+1	K984158	P.F.C. Modular Plus Offset Tibial Tray	Depuy, Inc.	1999	—
+2	K163167	CKS Plus Knee System	Consensus Orthopedics, Inc.	2017	—
+2	K013906	HLS Noetos System	Tornier	2002	—
+3	K191765	OMNI TiN Coated Apex Knee™ System	Omni Life Science, Inc.	2019	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0
1999	1	0
2002	1	0
2003	1	0
2010	1	0
2011	2	0
2012	1	0
2013	1	0
2016	1	0
2017	1	0
2019	2	0
2020	1	0
2021	2	0
2024	2	0
2025	1	0

FIG. 1 — Lineage of K884796, 1989–2025Source: 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 JWH? 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 JWH device

#1 K221479 Persona Personalized Knee Systemscore 22.4 · 11 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? (19)

See all 19

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

Number	Device	Applicant	Decided	Descendants
K954818	Consensus Posterior Stabilized Knee	U.S. Medical Products, Inc.	1996	9
K984158	P.F.C. Modular Plus Offset Tibial Tray	Depuy, Inc.	1999	7
K182301	PFC SIGMA Knee System	DePuy Orthopaedics, Inc.	2019	1
K241000	ATTUNE™ Revision Knee System; DePuy Knee Prosthesis System Universal Stem Extensions and…	Depuy Ireland UC	2024	0
K102367	Optigen Total Knee System	U&I Corp.	2010	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jun 28, 2011	Not classified	Z-3099-2011	Employee error	DePuy initiated a voluntary recall effective immediately, for one lot of P.F.C. SIGMA RD Dome Patella 3 Peg (38mm) due to packaging labels that did not correctly reflect the size of the enclosed patellar component. In the recalled lot…
May 26, 2005	Not classified	Z-1338-05	Other	An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
May 26, 2005	Not classified	Z-1333-05	Other	An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
May 26, 2005	Not classified	Z-1337-05	Other	An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
May 26, 2005	Not classified	Z-1335-05	Other	An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
May 26, 2005	Not classified	Z-1336-05	Other	An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
May 26, 2005	Not classified	Z-1342-05	Other	An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
May 26, 2005	Not classified	Z-1332-05	Other	An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
May 26, 2005	Not classified	Z-1346-05	Other	An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
May 26, 2005	Not classified	Z-1334-05	Other	An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
May 26, 2005	Not classified	Z-1339-05	Other	An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
May 26, 2005	Not classified	Z-1343-05	Other	An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
May 26, 2005	Not classified	Z-1345-05	Other	An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
May 26, 2005	Not classified	Z-1344-05	Other	An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
May 26, 2005	Not classified	Z-1340-05	Other	An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
May 26, 2005	Not classified	Z-1341-05	Other	An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.

The 5 latest of 16 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K954818 (U.S. Medical Products, Inc., 1996) has gone furthest, with 9 descendants of its own.

How does its category compare?

All JWH devices

JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JWH

20in 2025

2007high 33 (2012) · low 11 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JWH

55in 2025

2007high 168 (2009) · low 55 (2025)2026

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

Recalls per year · JWH

2in 2025

2007high 109 (2009) · low 2 (2020)2026

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

Adverse event reports per year · JWH

9,306in 2025

2007high 14,987 (2019) · low 1,305 (2007)2025

MAUDE reports naming product code JWH, 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	18	74	14	1,305
2008	17	81	10	1,483
2009	11	168	109	1,870
2010	19	85	32	3,286
2011	25	87	27	5,133
2012	33	85	85	5,203
2013	31	128	31	6,135
2014	33	98	13	6,722
2015	27	87	11	6,881
2016	18	88	17	7,586
2017	25	118	61	12,263
2018	25	90	14	14,071
2019	28	133	5	14,987
2020	22	59	2	12,592
2021	24	61	8	9,408
2022	17	56	12	8,364
2023	20	57	67	8,947
2024	19	89	7	10,828
2025	20	55	2	9,306
2026	12	63	4	—

https://510kreport.com/device/K884796 · printed Nov 6, 2026

Cite this page

510(k) Report. “K884796: P.F.C.(TM) Modular Knee System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K884796

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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