510(k) · Cleared

Cleared

P.F.C. Sigma Inset Patella

K971652510(k) TraditionalCleared Jul 16, 199771-day reviewClass II21 CFR 888.3560

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 Jul 16, 1997 as substantially equivalent to K961685 (Johnson & Johnson Professionals, Inc., 1996) and 1 other predicate after a 71-day review. Its family tree reaches back 1 generation to 1994. 1 later device descends from it.

Decided: Jul 16, 1997
Review: 71 days
Class: Class II
Product code: JWH
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K933867 (1994). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK933867 Universal Inset PatellaJohnson & Johnson Orthopaedics, Inc. · 1994
This deviceK971652 P.F.C. Sigma Inset PatellaJohnson & Johnson Professionals, Inc. · 1997
Descendant · cites it directly · 0 of its ownK241000 ATTUNE™ Revision Knee System; DePuy Knee Prosthesis System Universal…Depuy Ireland UC · 2024

Most influential descendants

Showing 1 of 1 · See all

K241000ATTUNE™ Revision Knee System; DePuy Knee Prosthesis System Universal Stem Extensions and…Depuy Ireland UC · 2024 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K933867	Universal Inset Patella	Johnson & Johnson Orthopaedics, Inc.	1994	—
0 (this device)	K971652	P.F.C. Sigma Inset Patella	Johnson & Johnson Professionals, Inc.	1997	—
+1	K241000	ATTUNE™ Revision Knee System; DePuy Knee Prosthesis System Universal Stem…	Depuy Ireland UC	2024	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2024	1	0

FIG. 1 — Lineage of K971652, 1994–2024Source: 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 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

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What was it cleared against? (2)

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
*	K961685	P.F.C. Cruciate Retaining Knee System (Size 1.5) Summary page 1 …ical Characteristics Compared to Predicate Device o PECYL . \| o PFC®Z J .~ “Universal ' InsetPatella . \| Oval-DomePatella \| - InsetPatella’ (subject of this submission) K961685 K933867 Design Bone Removal reamed cavity planar resection reamed cavity Bone Periphery @ Major yes no yes Diameter Articulating…	Johnson & Johnson Professionals, Inc.	1996	7
*	K933867	Universal Inset Patella Summary page 1 …racteristics Compared to Predicate Device o PECYL . \| o PFC®Z J .~ “Universal ' InsetPatella . \| Oval-DomePatella \| - InsetPatella’ (subject of this submission) K961685 K933867 Design Bone Removal reamed cavity planar resection reamed cavity Bone Periphery @ Major yes no yes Diameter Articulating Surface…	Johnson & Johnson Orthopaedics, Inc.	1994	—

Also cleared against K961685: 12 other devices →

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K241000	ATTUNE™ Revision Knee System; DePuy Knee Prosthesis System Universal Stem Extensions and…	Depuy Ireland UC	2024	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?

1 of the 2 ancestors has a recall of any class.
Of its descendants, K241000 (Depuy Ireland UC, 2024) has gone furthest, with 0 descendants of its own.
12 other devices also cite its predicate K961685.

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	—

What is it indicated for?

The P.F.C.® T Sigma Knee System is indicated for use only with bone cement (PMMA) for patients suffering from severe pain and disability due to permanent structural damage resulting from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders or pseudogout. This damage may also be the result of trauma or failed prior surgical intervention.

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/K971652 · printed Nov 4, 2026

Cite this page

510(k) Report. “K971652: P.F.C. Sigma Inset Patella.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971652

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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