510(k) · Cleared

Cleared

Consensus PCL Subsituting Tibial Insert

K953443510(k) TraditionalCleared Apr 26, 1996284-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 26, 1996 as substantially equivalent to K912663 (Intermedics Orthopedics, 1991) after a 284-day review. Its family tree reaches back 1 generation to 1991. 9 later devices descend from it.

Decided: Apr 26, 1996
Review: 284 days
Class: Class II
Product code: JWH
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K912663 (1991). 9 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK912663 Natural-Knee Ultra Congruent Tibial InsertIntermedics Orthopedics · 1991
This deviceK953443 Consensus PCL Subsituting Tibial InsertU.S. Medical Products, Inc. · 1996
Descendant · cites it directly · 7 of its ownK133919 Consensus Vitalite Tibial InsertConsensus Orthopedics, Inc. · 2014
Descendant · cites it directly · 3 of its ownK163167 CKS Plus Knee SystemConsensus Orthopedics, Inc. · 2017
Descendant · 2 generations on · 2 of its ownK191765 OMNI TiN Coated Apex Knee™ SystemOmni Life Science, Inc. · 2019
Descendant · 2 generations on · 2 of its ownK160515 PS2 Knee SystemConsensus Orthopedics, Inc. · 2016
Descendant · 3 generations on · 1 of its ownK191084 The Optimotion Blue Total Knee SystemOptimotion Implants, LLC · 2020

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2013high 1 (2013) · low 0 (2015)2026

Most influential descendants

Showing 5 of 9 · See all

K133919Consensus Vitalite Tibial InsertConsensus Orthopedics, Inc. · 2014 · cites it directly7descendants
K163167CKS Plus Knee SystemConsensus Orthopedics, Inc. · 2017 · cites it directly3descendants
K191765OMNI TiN Coated Apex Knee™ SystemOmni Life Science, Inc. · 2019 · 2 generations on2descendants
K160515PS2 Knee SystemConsensus Orthopedics, Inc. · 2016 · 2 generations on2descendants
K191084The Optimotion Blue Total Knee SystemOptimotion Implants, LLC · 2020 · 3 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K912663	Natural-Knee Ultra Congruent Tibial Insert	Intermedics Orthopedics	1991	—
0 (this device)	K953443	Consensus PCL Subsituting Tibial Insert	U.S. Medical Products, Inc.	1996	—
+1	K133919	Consensus Vitalite Tibial Insert	Consensus Orthopedics, Inc.	2014	—
+1	K163167	CKS Plus Knee System	Consensus Orthopedics, Inc.	2017	—
+2	K191765	OMNI TiN Coated Apex Knee™ System	Omni Life Science, Inc.	2019	—
+2	K160515	PS2 Knee System	Consensus Orthopedics, Inc.	2016	—
+3	K191084	The Optimotion Blue Total Knee System	Optimotion Implants, LLC	2020	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2013	1	0
2014	1	0
2016	1	0
2017	1	0
2019	1	0
2020	1	0
2021	1	0
2024	1	0
2025	1	0

FIG. 1 — Lineage of K953443, 1991–2025Source: 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? (1)

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
*	K912663	Natural-Knee Ultra Congruent Tibial Insert Summary page 1 …n 21CFR888.3560. Substantial Equivalence: equivalent PCL Substituting Tibial Insert component: Intermedics Orthopedics, Inc. Natural Knee® Ultracongruent Tibial Insert K912663 SE 09-16-91 Device Description: The Consensus® Knee PCL Substituting Tibial Insert component is manufactured from ultra-high mol…	Intermedics Orthopedics	1991	—

Also cleared against K912663: 1 other device →

What descends from it? (9)

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

Number	Device	Applicant	Decided	Descendants
K133919	Consensus Vitalite Tibial Insert	Consensus Orthopedics, Inc.	2014	7
K163167	CKS Plus Knee System	Consensus Orthopedics, Inc.	2017	3
K130084	Milestone Revision Knee System (MRKS) - Femoral Component, Tibial Baseplate, Tibial…	Tgm Medical, Inc.	2013	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?

Its one ancestor has no recall.
Of its descendants, K133919 (Consensus Orthopedics, Inc., 2014) has gone furthest, with 7 descendants of its own.
1 other device also cites its predicate K912663.

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® PCL Substituting Tibial Insert 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/K953443 · printed Nov 4, 2026

Cite this page

510(k) Report. “K953443: Consensus PCL Subsituting Tibial Insert.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K953443

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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