510(k) · Cleared

Cleared

Depuy Sigma PS Femoral Components

K073529510(k) SpecialCleared Jan 24, 200838-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

DePuy Orthopaedics, Inc. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Cleared on Jan 24, 2008 as substantially equivalent to K950010 (Johnson & Johnson Professionals, Inc., 1995) and 1 other predicate after a 38-day review. Its family tree reaches back 1 generation to 1995. 40 later devices descend from it.

Decided: Jan 24, 2008
Review: 38 days
Class: Class II
Product code: JWH
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K950010 (1995). 2 ancestors in all. 40 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK950010 Darwin Knee System (Cruciate Substituting) Porous Coated and…Johnson & Johnson Professionals, Inc. · 1995 · Recalled
This deviceK073529 Depuy Sigma PS Femoral ComponentsDePuy Orthopaedics, Inc. · 2008
Descendant · cites it directly · 39 of its ownK111433 Depuy Sttune (TM) PS Knee SystemDePuy Orthopaedics, Inc. · 2011 · Recalled
Descendant · 2 generations on · 26 of its ownK140833 Itotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc. · 2014
Descendant · 3 generations on · 24 of its ownK142404 iTotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc. · 2014 · Recalled
Descendant · 3 generations on · 24 of its ownK142161 Itotal Cruciate Retaining (CR) Knee Replacement System, Itotal…Conformis, Inc. · 2014 · Recalled
Descendant · 4 generations on · 23 of its ownK152704 iTotal Posterior Stabilized Knee Replacement System, iTotal Cruciate…Conformis, Inc. · 2015

Showing 5 of 40 descendants. See all descendants

Descendants cleared per year

2011high 6 (2016) · low 0 (2012)2026

Most influential descendants

Showing 5 of 40 · See all

K111433Depuy Sttune (TM) PS Knee SystemDePuy Orthopaedics, Inc. · 2011 · cites it directly39descendants
K140833Itotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc. · 2014 · 2 generations on26descendants
K142404iTotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc. · 2014 · 3 generations on24descendants
K142161Itotal Cruciate Retaining (CR) Knee Replacement System, Itotal Posterior Stabilized (PS)…Conformis, Inc. · 2014 · 3 generations on24descendants
K152704iTotal Posterior Stabilized Knee Replacement System, iTotal Cruciate Retaining Knee…Conformis, Inc. · 2015 · 4 generations on23descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K950010	Darwin Knee System (Cruciate Substituting) Porous Coated and Non-Porous Coated	Johnson & Johnson Professionals, Inc.	1995	16
0 (this device)	K073529	Depuy Sigma PS Femoral Components	DePuy Orthopaedics, Inc.	2008	—
+1	K111433	Depuy Sttune (TM) PS Knee System	DePuy Orthopaedics, Inc.	2011	1
+2	K140833	Itotal Posterior Stabilized (PS) Knee Replacement System	Conformis, Inc.	2014	—
+3	K142404	iTotal Posterior Stabilized (PS) Knee Replacement System	Conformis, Inc.	2014	2
+3	K142161	Itotal Cruciate Retaining (CR) Knee Replacement System, Itotal Posterior…	Conformis, Inc.	2014	6
+4	K152704	iTotal Posterior Stabilized Knee Replacement System, iTotal Cruciate Retaining…	Conformis, Inc.	2015	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	1	0
2014	3	0
2015	2	0
2016	6	0
2018	1	0
2019	2	0
2020	4	0
2021	5	0
2022	2	0
2023	5	0
2024	3	0
2025	1	0
2026	5	0

FIG. 1 — Lineage of K073529, 1995–2026Source: 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

Get a 510(k) Report

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
*	K950010	Darwin Knee System (Cruciate Substituting) Porous Coated and Non-Porous Coated Summary page 1 …ed cemented prosthesis; Class II PRODUCT CODE: JWH SUBSTANTIALLY EQUIVALENT DEVICES: Darwin Knee System, K950010 PFC Sigma Knee System (Size 1.5), K971189 DEVICE DESCRIPTION: The Sigma PS Femoral Components ar…	Johnson & Johnson Professionals, Inc.	1995	16
*	K971189	P.F.C. Sigma Knee System (Size 1.5) Summary page 1 …CODE: JWH SUBSTANTIALLY EQUIVALENT DEVICES: Darwin Knee System, K950010 PFC Sigma Knee System (Size 1.5), K971189 DEVICE DESCRIPTION: The Sigma PS Femoral Components are part of the Sigma Total Knee Replacement System. They are Co-Cr-Mo alloy…	Johnson & Johnson Professionals, Inc.	1997	—

Also cleared against K950010: 9 other devices →

What descends from it? (40)

See all 40

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

Number	Device	Applicant	Decided	Descendants
K111433	Depuy Sttune (TM) PS Knee System	DePuy Orthopaedics, Inc.	2011	39
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, K111433 (DePuy Orthopaedics, Inc., 2011) has gone furthest, with 39 descendants of its own.
9 other devices also cite its predicate K950010.

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. 2008, this device’s year, is highlighted.

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 Sigma PS Femoral Components are intended for cemented use as the femoral components of a Total Knee Replacement system. Candidates for total knee replacement include elderly patients with a severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or a failed previous implant. Total knee replacement may be considered for younger patients if, in the opinion of the surgeon, an…

Read the full statement (120 words)

The Sigma PS Femoral Components are intended for cemented use as the femoral components of a Total Knee Replacement system.

Candidates for total knee replacement include elderly patients with a severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or a failed previous implant. Total knee replacement may be considered for younger patients if, in the opinion of the surgeon, an unequivocal indication for total knee replacement outweighs the risks associated with the age of the patient, and if limited demands regarding activity and knee joint loading can be assured. This includes severely crippled patients with multiple joint involvement for whom a gain in knee mobility may lead to significant improvement in their quality of life.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K073529 · printed Nov 4, 2026

Cite this page

510(k) Report. “K073529: Depuy Sigma PS Femoral Components.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073529

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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