510(k) · Cleared

Cleared

PS2 Knee System

K160515510(k) TraditionalCleared Dec 19, 2016299-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

Consensus Orthopedics, Inc. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Cleared on Dec 19, 2016 as substantially equivalent to K110950 (Consensus Orthopedics, Inc., 2011) and 9 other predicates after a 299-day review. Its family tree reaches back 7 generations to 1995. 2 later devices descend from it.

Decided: Dec 19, 2016
Review: 299 days
Class: Class II
Product code: JWH
Recalls: None
Predicates: 10

Its longest line of descent runs back 7 generations to K933785 (1995). 26 ancestors in all, the oldest K884796 (1989). 2 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 7 generations backK933785 Next Generation Knee SystemZimmer, Inc. · 1995 · Recalled
6 generations backK023211 Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral…Zimmer, Inc. · 2002 · Recalled
5 generations backK060370 Nexgen Knee Gender Solutions Female (GSF) Femoral ComponentsZimmer, Inc. · 2006 · Recalled
4 generations backK070214 Gender Solutions Natural-Knee Flex SystemZimmer, Inc. · 2007 · Recalled
3 generations backK073286 Gender Solutions Natural-Knee Flex SystemZimmer, Inc. · 2008 · Recalled
2 generations backK110950 Consensus Knee SystemConsensus Orthopedics, Inc. · 2011
1 generation backK133919 Consensus Vitalite Tibial InsertConsensus Orthopedics, Inc. · 2014
This deviceK160515 PS2 Knee SystemConsensus Orthopedics, Inc. · 2016
Descendant · cites it directly · 1 of its ownK191084 The Optimotion Blue Total Knee SystemOptimotion Implants, LLC · 2020
Descendant · 2 generations on · 0 of its ownK240938 The Optimotion™ Blue Plus Knee SystemOptimotion Implants, LLC · 2024

Most influential descendants

Showing 2 of 2 · See all

K191084The Optimotion Blue Total Knee SystemOptimotion Implants, LLC · 2020 · cites it directly1descendant
K240938The Optimotion™ Blue Plus Knee SystemOptimotion Implants, LLC · 2024 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−7	K933785	Next Generation Knee System	Zimmer, Inc.	1995	83
−6	K023211	Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral Components	Zimmer, Inc.	2002	6
−5	K060370	Nexgen Knee Gender Solutions Female (GSF) Femoral Components	Zimmer, Inc.	2006	17
−4	K070214	Gender Solutions Natural-Knee Flex System	Zimmer, Inc.	2007	63
−3	K073286	Gender Solutions Natural-Knee Flex System	Zimmer, Inc.	2008	5
−2	K110950	Consensus Knee System	Consensus Orthopedics, Inc.	2011	—
−1	K133919	Consensus Vitalite Tibial Insert	Consensus Orthopedics, Inc.	2014	—
0 (this device)	K160515	PS2 Knee System	Consensus Orthopedics, Inc.	2016	—
+1	K191084	The Optimotion Blue Total Knee System	Optimotion Implants, LLC	2020	—
+2	K240938	The Optimotion™ Blue Plus Knee System	Optimotion Implants, LLC	2024	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1989	1	0
1991	1	0
1994	1	0
1995	2	0
1996	3	0
1997	1	0
1999	1	0
2000	2	0
2001	2	0
2003	1	0
2005	1	0
2007	1	0
2010	1	0
2015	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2020	1	0
2024	1	0

FIG. 1 — Lineage of K160515, 1995–2024Source: 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? (10)

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
*	K110950	Consensus Knee System Summary page 5 …PS2 cruciate retaining (CR) femoral component is substantially equivalent to the Consensus Knee System (CKS) Reduced Lateral Profile (RLP) uncoated CR femoral component (K110950). The PS2 posterior stabilized (PS) femoral component is substantially equivalent to the CKS RLP uncoated PS femoral component (K…	Consensus Orthopedics, Inc.	2011	—
*	K932837	Consensus Knee System - Primary Knee Summary page 5 …o the CKS RLP uncoated PS femoral component (K110950). The PS2 CR tibial insert is substantially equivalent to the CKS congruent tibial insert made from standard UHMWPE (K932837, K110950) or VitalitE (K133919). The PS2 PS tibial insert is substantially equivalent to the CKS PS tibial insert made from stand…	U.S. Medical Products, Inc.	1994	—
*	K945589	Consensus (TM) Knee Cobalt Chrome Nonporous Stemmed Tibial Baseplate Summary page 5 …nstrained tibial insert (Smith & Nephew, K962137). The PS2 baseplate is substantially equivalent to the CKS modular baseplate (K143725), the CKS uncoated CoCr baseplate (K945589, K001456, K110950), and the Consensus Revision Knee System (CRKS) baseplate (K100542). The PS2 oval and round patellar components…	U.S. Medical Products, Inc.	1995	—
*	K951987	Genesis II Total Knee System Summary page 5 …al insert made from standard UHMWPE (K954818, K110950). The 25mm PS2 tibial inserts are substantially equivalent to the 25mm Genesis II PS tibial insert (Smith & Nephew, K951987). The 30mm PS2 tibial inserts are substantially equivalent to the 30mm Genesis II PS constrained tibial insert (Smith & Nephew, K…	Smith & Nephew Richards, Inc.	1995	6
*	K954818	Consensus Posterior Stabilized Knee Summary page 5 …rom standard UHMWPE (K932837, K110950) or VitalitE (K133919). The PS2 PS tibial insert is substantially equivalent to the CKS PS tibial insert made from standard UHMWPE (K954818, K110950). The 25mm PS2 tibial inserts are substantially equivalent to the 25mm Genesis II PS tibial insert (Smith & Nephew, K951…	U.S. Medical Products, Inc.	1996	—
*	K962137	Genesis II Constrained System Summary page 5 …PS tibial insert (Smith & Nephew, K951987). The 30mm PS2 tibial inserts are substantially equivalent to the 30mm Genesis II PS constrained tibial insert (Smith & Nephew, K962137). The PS2 baseplate is substantially equivalent to the CKS modular baseplate (K143725), the CKS uncoated CoCr baseplate (K945589,…	Smith & Nephew Richards, Inc.	1996	1
*	K001456	Consensus Knee System Summary page 5 …tibial insert (Smith & Nephew, K962137). The PS2 baseplate is substantially equivalent to the CKS modular baseplate (K143725), the CKS uncoated CoCr baseplate (K945589, K001456, K110950), and the Consensus Revision Knee System (CRKS) baseplate (K100542). The PS2 oval and round patellar components are subs…	Hayes Medical, Inc.	2000	—
*	K100542	Consensus Revision Knee System Summary page 5 …equivalent to the CKS modular baseplate (K143725), the CKS uncoated CoCr baseplate (K945589, K001456, K110950), and the Consensus Revision Knee System (CRKS) baseplate (K100542). The PS2 oval and round patellar components are substantially equivalent to the CKS oval and round all-poly patellar components…	Consensus Orthopedics, Inc.	2010	—
*	K133919	Consensus Vitalite Tibial Insert Summary page 5 …al component (K110950). The PS2 CR tibial insert is substantially equivalent to the CKS congruent tibial insert made from standard UHMWPE (K932837, K110950) or VitalitE (K133919). The PS2 PS tibial insert is substantially equivalent to the CKS PS tibial insert made from standard UHMWPE (K954818, K110950).…	Consensus Orthopedics, Inc.	2014	—
*	K143725	Consensus Knee System Modular Tibial Baseplate Summary page 5 …lly equivalent to the 30mm Genesis II PS constrained tibial insert (Smith & Nephew, K962137). The PS2 baseplate is substantially equivalent to the CKS modular baseplate (K143725), the CKS uncoated CoCr baseplate (K945589, K001456, K110950), and the Consensus Revision Knee System (CRKS) baseplate (K100542).…	Consensus Orthopedics, Inc.	2015	—

Also cleared against K110950: 7 other devices →

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K191084	The Optimotion Blue Total Knee System	Optimotion Implants, LLC	2020	1

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 21 years and passes through 2 companies; a new generation was cleared every 3.0 years on median.
13 of the 26 ancestors have a recall of any class.
Of its descendants, K191084 (Optimotion Implants, LLC, 2020) has gone furthest, with 1 descendant of its own.
7 other devices also cite its predicate K110950.

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. 2016, 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 PS2 KNEE SYSTEM is designed as a system and is not intended for substitution of components from other systems.

The indications for use are:

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

B. Failed osteotomy or unicompartmental replacements.

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

D. The PS2 KNEE SYSTEM is intended for cemented use.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K160515 · printed Nov 6, 2026

Cite this page

510(k) Report. “K160515: PS2 Knee System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160515

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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