510(k) · Cleared

Cleared

Consensus All Poly Tibia

K952943510(k) TraditionalCleared Apr 1, 1996280-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

U.S. Medical Products, Inc. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Cleared on Apr 1, 1996 as substantially equivalent to K922048 (Howmedica Corp., 1992) and 2 other predicates after a 280-day review. Its family tree reaches back 1 generation to 1991.

Decided: Apr 1, 1996
Review: 280 days
Class: Class II
Product code: JWH
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K910563 (1991). 3 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK910563 P.F.C.(R) Modular Knee Syst, Stab All-Plast TibialJohnson & Johnson Orthopaedics, Inc. · 1991
This deviceK952943 Consensus All Poly TibiaU.S. Medical Products, Inc. · 1996

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K910563	P.F.C.(R) Modular Knee Syst, Stab All-Plast Tibial	Johnson & Johnson Orthopaedics, Inc.	1991	—
0 (this device)	K952943	Consensus All Poly Tibia	U.S. Medical Products, Inc.	1996	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1992	1	0
1993	1	0

FIG. 1 — Lineage of K952943, 1991–1996Source: 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? (3)

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
*	K922048	Duracon All Plastic Tibial Component Summary page 1 …lymer, under classification 21CFR888.3560. Substantial Equivalence: equivalent All poly tibia components are as follows: Howmedica Duracon All Plastic Tibial component K922048 SE Sep 8, 1992 Intermedics Orthopedics All-Poly Tibia K923443 SE 3-31-93 Johnson&Johnson PFC All Plastic Tibia K910563 SE 5-23-91…	Howmedica Corp.	1992	—
*	K923443	Natural-Knee All-Poly Tibia Summary page 1 …lence: equivalent All poly tibia components are as follows: Howmedica Duracon All Plastic Tibial component K922048 SE Sep 8, 1992 Intermedics Orthopedics All-Poly Tibia K923443 SE 3-31-93 Johnson&Johnson PFC All Plastic Tibia K910563 SE 5-23-91 Device Description: The Consensus® Knee All Poly Tibia compo…	Intermedics Orthopedics	1993	—
*	K910563	P.F.C.(R) Modular Knee Syst, Stab All-Plast Tibial Summary page 1 …s: Howmedica Duracon All Plastic Tibial component K922048 SE Sep 8, 1992 Intermedics Orthopedics All-Poly Tibia K923443 SE 3-31-93 Johnson&Johnson PFC All Plastic Tibia K910563 SE 5-23-91 Device Description: The Consensus® Knee All Poly Tibia component is manufactured from ultra-high molecular weight pol…	Johnson & Johnson Orthopaedics, Inc.	1991	—

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?

None of the 3 ancestors has a recall.

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 Consensus® All Poly Tibia is indicated for use in:

1. Primary intervention of rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, or degenerative arthritis.

2. Failed osteotomy or unicompartmental replacements

3. Replacement of unsatisfactory cemented or press-fit knee components when sufficient bone stock exists.

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/K952943 · printed Nov 4, 2026

Cite this page

510(k) Report. “K952943: Consensus All Poly Tibia.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K952943

Report an extraction error

Are you the manufacturer?

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