510(k) · Cleared

Cleared

PFC SIGMA Knee System

K182301510(k) TraditionalCleared Nov 8, 2019441-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 Nov 8, 2019 as substantially equivalent to K882234 (Johnson & Johnson Professionals, Inc., 1988) and 12 other predicates after a 441-day review. Its family tree reaches back 4 generations to 1987. 1 later device descends from it.

Decided: Nov 8, 2019
Review: 441 days
Class: Class II
Product code: JWH
Recalls: None
Predicates: 13

Its longest line of descent runs back 4 generations to K870730 (1987). 30 ancestors in all, the oldest K864671 (1987). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 4 generations backK870730 Noiles Total Knee ProsthesisJoint Medical Products Corp. · 1987
3 generations backK003182 Orthogenesis LPS SystemDepuy, Inc. · 2001
2 generations backK040281 LPS Metaphyseal Sleeve (Limb Preservation System)DePuy Orthopaedics, Inc. · 2004
1 generation backK060515 Depuy PFC Sigma Knee ProsthesisDePuy Orthopaedics, Inc. · 2006
This deviceK182301 PFC SIGMA Knee SystemDePuy Orthopaedics, Inc. · 2019
Descendant · cites it directly · 0 of its ownK200765 Genius / Genuin Total Knee SystemBiorad Medisys Pvt, Ltd. · 2021

Most influential descendants

Showing 1 of 1 · See all

K200765Genius / Genuin Total Knee SystemBiorad Medisys Pvt, Ltd. · 2021 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K870730	Noiles Total Knee Prosthesis	Joint Medical Products Corp.	1987	—
−3	K003182	Orthogenesis LPS System	Depuy, Inc.	2001	—
−2	K040281	LPS Metaphyseal Sleeve (Limb Preservation System)	DePuy Orthopaedics, Inc.	2004	—
−1	K060515	Depuy PFC Sigma Knee Prosthesis	DePuy Orthopaedics, Inc.	2006	—
0 (this device)	K182301	PFC SIGMA Knee System	DePuy Orthopaedics, Inc.	2019	—
+1	K200765	Genius / Genuin Total Knee System	Biorad Medisys Pvt, Ltd.	2021	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1987	1	0
1988	1	0
1989	2	0
1990	1	0
1991	1	0
1992	1	0
1993	1	0
1994	3	0
1995	2	0
1996	4	0
1997	3	0
1998	1	0
1999	2	0
2003	1	0
2006	1	0
2007	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2021	1	0

FIG. 1 — Lineage of K182301, 1987–2021Source: 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? (13)

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
*	K882234	Johnson & Johnson Modular Total Knee Prosthesis Summary page 4 …87 Orthopedics Regulation 21 CFR 888.3560, 21 CFR 888.3565 Product Code(s) JWH, MBH Legally marketed device(s) K882234, K884796, PFC SIGMA Knee System, Tibial Tray to which equivalence is K952830, K961685, claimed.…	Johnson & Johnson Professionals, Inc.	1988	—
*	K884796	P.F.C.(TM) Modular Knee System Summary page 4 …rthopedics Regulation 21 CFR 888.3560, 21 CFR 888.3565 Product Code(s) JWH, MBH Legally marketed device(s) K882234, K884796, PFC SIGMA Knee System, Tibial Tray to which equivalence is K952830, K961685, claimed.…	Johnson & Johnson Professionals, Inc.	1989	16
*	K952830	Darwin Knee System (TC3) Summary page 4 …Code(s) JWH, MBH Legally marketed device(s) K882234, K884796, PFC SIGMA Knee System, Tibial Tray to which equivalence is K952830, K961685, claimed. K971189 K952830 PFC SIGMA Kne…	Johnson & Johnson Professionals, Inc.	1996	8
*	K961685	P.F.C. Cruciate Retaining Knee System (Size 1.5) Summary page 4 …JWH, MBH Legally marketed device(s) K882234, K884796, PFC SIGMA Knee System, Tibial Tray to which equivalence is K952830, K961685, claimed. K971189 K952830 PFC SIGMA Knee System,…	Johnson & Johnson Professionals, Inc.	1996	7
*	K971189	P.F.C. Sigma Knee System (Size 1.5) Summary page 4 …device(s) K882234, K884796, PFC SIGMA Knee System, Tibial Tray to which equivalence is K952830, K961685, claimed. K971189 K952830 PFC SIGMA Knee System, Fluted Tibial Rod Note: The primary predicat…	Johnson & Johnson Professionals, Inc.	1997	—
*	K063633	Depuy Knee Prosthesis System Universal Stem Extensions and Femoral Metaphyseal Sleeves Summary page 4 …d Note: The primary predicate device is K032115. All K882234 PFC SIGMA Knee System, Taper Femoral Stem others are additional K063633 PFC SIGMA Knee System, Universal Stem predicate devices. K943462, K961685, PFC SIGMA C…	DePuy Orthopaedics, Inc.	2007	1
*	K943462	Darwin Knee System Summary page 4 …A Knee System, Taper Femoral Stem others are additional K063633 PFC SIGMA Knee System, Universal Stem predicate devices. K943462, K961685, PFC SIGMA Cruciate Knee System K062654…	Johnson & Johnson Professionals, Inc.	1994	8
*	K062654	Depuy Sigma Cruciate Retaining Porocoat Femoral Components Summary page 4 …PFC SIGMA Knee System, Universal Stem predicate devices. K943462, K961685, PFC SIGMA Cruciate Knee System K062654 K950010, K952830, PFC SIGMA Knee System K971189…	DePuy Orthopaedics, Inc.	2006	—
*	K950010	Darwin Knee System (Cruciate Substituting) Porous Coated and Non-Porous Coated Summary page 4 …dicate devices. K943462, K961685, PFC SIGMA Cruciate Knee System K062654 K950010, K952830, PFC SIGMA Knee System K971189 K952830,…	Johnson & Johnson Professionals, Inc.	1995	16
*	K060515	Depuy PFC Sigma Knee Prosthesis Summary page 4 …K950010, K952830, PFC SIGMA Knee System K971189 K952830, K060515 PFC SIGMA Knee System, adaptors and bolts K991106 PFC SIGMA Porous…	DePuy Orthopaedics, Inc.	2006	—
*	K991106	P.F.C. Sigma Porous Modular Keel Tibial Tray Summary page 4 …K971189 K952830, K060515 PFC SIGMA Knee System, adaptors and bolts K991106 PFC SIGMA Porous Modular Keel Tray K984158 PFC SIGMA Plus…	DePuy Orthopaedics, Inc.	1999	—
*	K984158	P.F.C. Modular Plus Offset Tibial Tray Summary page 4 …IGMA Knee System, adaptors and bolts K991106 PFC SIGMA Porous Modular Keel Tray K984158 PFC SIGMA Plus Offset Tibial Tray K032115 (Primary) PFC SIGMA Co-Cr…	Depuy, Inc.	1999	—
*	K032151	Depuy Sigma Tibial Inserts and CO-CR Tibial Trays Our reading of the summary gave K032115, FDA’s number for Neurolac Nerve Guide Models NG01-15/03, NG01-020/03, NG01… (Polyganics B.V.,). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “PFC SIGMA Co-Cr Tibial Tray”.	Depuy, Inc.	2003	12

Also cleared against K882234: 1 other device →

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
K200765	Genius / Genuin Total Knee System	Biorad Medisys Pvt, Ltd.	2021	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?

The line of descent spans 32 years and passes through 3 companies; a new generation was cleared every 13.6 years on median.
10 of the 30 ancestors have a recall of any class.
Of its descendants, K200765 (Biorad Medisys Pvt, Ltd., 2021) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K882234.

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. 2019, 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?

Candidates for total or unicompartmental knee replacement include patients with a severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or a failed previous implant. In candidates for unicompartmental knee arthroplasty, only one side of the joint (the medial or lateral compartment) is affected.

The Sigma® C/R Porocoat® Femoral Components are intended for cemented or cementless use as the femoral component of a Total Knee Replacement system.

In the US, all other porous coated components have been cleared for CEMENTED USE ONLY. Any Non-Porous coated components are intended for CEMENTED USE ONLY.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K182301 · printed Nov 5, 2026

Cite this page

510(k) Report. “K182301: PFC SIGMA Knee System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K182301

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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