510(k) · Cleared

Cleared

PFC Sigma Lugged Tibial Tray

K003026510(k) TraditionalCleared Jun 19, 2001264-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 Jun 19, 2001 as substantially equivalent to K931054 (Johnson & Johnson Orthopaedics, Inc., 1994) and 1 other predicate after a 264-day review. Its family tree reaches back 2 generations to 1987.

Decided: Jun 19, 2001
Review: 264 days
Class: Class II
Product code: JWH
Recalls: None
Predicates: 2

Its longest line of descent runs back 2 generations to K864671 (1987). 7 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK864671 Anatomic Modular Knee (Amk) SystemDepuy, Inc. · 1987
1 generation backK991106 P.F.C. Sigma Porous Modular Keel Tibial TrayDePuy Orthopaedics, Inc. · 1999
This deviceK003026 PFC Sigma Lugged Tibial TrayDePuy Orthopaedics, Inc. · 2001

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K864671	Anatomic Modular Knee (Amk) System	Depuy, Inc.	1987	—
−1	K991106	P.F.C. Sigma Porous Modular Keel Tibial Tray	DePuy Orthopaedics, Inc.	1999	—
0 (this device)	K003026	PFC Sigma Lugged Tibial Tray	DePuy Orthopaedics, Inc.	2001	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1989	1	0
1992	1	0
1994	1	0
1996	2	0

FIG. 1 — Lineage of K003026, 1987–2001Source: 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
*	K931054	Trick Modular Knee Tibial Tray-Porous Summary page 2 …d Tibial Tray is substantially equivalent in terms of intended use, materials, design, sterilization method, and packaging to the Trick Modular Knee Tibial Tray —Porous (K931054) and the P.F.C. Sigma Porous Modular Keel Tibial Tray (K991106). The determination of substantial equivalence for this device wa…	Johnson & Johnson Orthopaedics, Inc.	1994	—
*	K991106	P.F.C. Sigma Porous Modular Keel Tibial Tray Summary page 2 …use, materials, design, sterilization method, and packaging to the Trick Modular Knee Tibial Tray —Porous (K931054) and the P.F.C. Sigma Porous Modular Keel Tibial Tray (K991106). The determination of substantial equivalence for this device was based on a detailed device description, and conformance with…	DePuy Orthopaedics, Inc.	1999	—

What descends from it?

No later submission names this one as a predicate yet.

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 14 years and passes through 2 companies; a new generation was cleared every 12.3 years on median.
2 of the 7 ancestors have a recall of any class.

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 PFC Sigma Lugged Tibial Tray is intended to provide increased mobility and reduced pain by replacing the damaged knee joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. 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…

Read the full statement (154 words)

The PFC Sigma Lugged Tibial Tray is intended to provide increased mobility and reduced

pain by replacing the damaged knee joint articulation in patients where there is evidence of

sufficient sound bone to seat and support the components. 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 unicondylar 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 an expectation of

significant improvement in the quality of their lives.

Caution: This knee prosthesis component is intended for cemented use only.

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/K003026 · printed Nov 6, 2026

Cite this page

510(k) Report. “K003026: PFC Sigma Lugged Tibial Tray.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003026

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026