510(k) · Cleared

Recalled · Class II · 2018

Smith & Nephew, Inc. High Performance Knee

K042515510(k) AbbreviatedCleared Mar 14, 2005179-day reviewClass II21 CFR 888.3560Recalls 3

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Smith & Nephew, Inc. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Cleared on Mar 14, 2005 as substantially equivalent to K951987 (Smith & Nephew Richards, Inc., 1995) and 2 other predicates after a 179-day review. Its family tree reaches back 1 generation to 1995. 118 later devices descend from it. It has been recalled 3 times.

Decided: Mar 14, 2005
Review: 179 days
Class: Class II
Product code: JWH
Recalls: 3
Predicates: 3

Its longest line of descent runs back 1 generation to K951987 (1995). 3 ancestors in all. 118 later devices descend from it, 12 citing it directly.

By dateBy generation

Root · 1 generation backK951987 Genesis II Total Knee SystemSmith & Nephew Richards, Inc. · 1995 · Recalled
This deviceK042515 Smith & Nephew, Inc. High Performance KneeSmith & Nephew, Inc. · 2005
Descendant · cites it directly · 66 of its ownK071071 Crosslinked Polyethylene Articular InsertsSmith & Nephew, Inc. · 2007 · Recalled
Descendant · cites it directly · 45 of its ownK101499 Journey CR Knee SystemSmith & Nephew, Inc. · 2010
Descendant · cites it directly · 41 of its ownK094050 Itotal CR Knee Replacement SystemConformis, Inc. · 2010
Descendant · cites it directly · 41 of its ownK091014 Journey BCS Knee SystemSmith & Nephew, Inc. · 2009
Descendant · cites it directly · 40 of its ownK111711 Journey II BCS Knee SystemSmith & Nephew, Inc. · 2011 · Recalled

Showing 5 of 118 descendants. See all descendants

Descendants cleared per year

2007high 12 (2023) · low 0 (2008)2026

Most influential descendants

Showing 5 of 118 · See all

K071071Crosslinked Polyethylene Articular InsertsSmith & Nephew, Inc. · 2007 · cites it directly66descendants
K101499Journey CR Knee SystemSmith & Nephew, Inc. · 2010 · cites it directly45descendants
K094050Itotal CR Knee Replacement SystemConformis, Inc. · 2010 · cites it directly41descendants
K091014Journey BCS Knee SystemSmith & Nephew, Inc. · 2009 · cites it directly41descendants
K111711Journey II BCS Knee SystemSmith & Nephew, Inc. · 2011 · cites it directly40descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K951987	Genesis II Total Knee System	Smith & Nephew Richards, Inc.	1995	6
0 (this device)	K042515	Smith & Nephew, Inc. High Performance Knee	Smith & Nephew, Inc.	2005	—
+1	K071071	Crosslinked Polyethylene Articular Inserts	Smith & Nephew, Inc.	2007	5
+1	K101499	Journey CR Knee System	Smith & Nephew, Inc.	2010	—
+1	K094050	Itotal CR Knee Replacement System	Conformis, Inc.	2010	—
+1	K091014	Journey BCS Knee System	Smith & Nephew, Inc.	2009	—
+1	K111711	Journey II BCS Knee System	Smith & Nephew, Inc.	2011	3

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0
1999	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0
2009	1	0
2010	3	0
2011	6	0
2012	8	0
2013	6	0
2014	10	0
2015	8	0
2016	5	0
2017	3	0
2018	3	0
2019	4	0
2020	9	0
2021	10	0
2022	9	0
2023	12	0
2024	7	0
2025	6	0
2026	7	0

FIG. 1 — Lineage of K042515, 1995–2026Source: 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
*	K951987	Genesis II Total Knee System Summary page 1 …principles, and material composition to the following predicate devices - Smith & Nephew Genesis IIKnee System and Genesis II& Profix Zirconium Femoral Knee Components (K951987 and K962557, respectively) and the Zimmer NexGen Complete Knee Solution LPS-Flex Fixed Bearing Femoral and Articular Surface Comp…	Smith & Nephew Richards, Inc.	1995	6
*	K962557	Genesis II Zirconium Femoral Component/Profix Zirconium Femoral Component Summary page 1 …and material composition to the following predicate devices - Smith & Nephew Genesis IIKnee System and Genesis II& Profix Zirconium Femoral Knee Components (K951987 and K962557, respectively) and the Zimmer NexGen Complete Knee Solution LPS-Flex Fixed Bearing Femoral and Articular Surface Components (K991…	Smith & Nephew Richards, Inc.	1996	1
*	K991581	Nexgen Complete Knee Solution Legacy Posterior Stabilized (LPS); LPS-Flex Fixed Bearing… Summary page 1 …Femoral Knee Components (K951987 and K962557, respectively) and the Zimmer NexGen Complete Knee Solution LPS-Flex Fixed Bearing Femoral and Articular Surface Components (K991581). Public Health Service DEPAR…	Zimmer, Inc.	1999	7

Also cleared against K951987: 31 other devices →

What descends from it? (118)

See all 118

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

Number	Device	Applicant	Decided	Descendants
K071071	Crosslinked Polyethylene Articular Inserts	Smith & Nephew, Inc.	2007	66
K101499	Journey CR Knee System	Smith & Nephew, Inc.	2010	45
K094050	Itotal CR Knee Replacement System	Conformis, Inc.	2010	41
K091014	Journey BCS Knee System	Smith & Nephew, Inc.	2009	41
K111711	Journey II BCS Knee System	Smith & Nephew, Inc.	2011	40
K152008	Physica PS Knee System	Lima Corporate S.P.A.	2015	7
K113482	Journey II Deep Dished Articular Inserts	Smith & Nephew, Inc.	2012	6
K211221	Porous Patella and Porous Tibia Baseplate	Smith & Nephew, Inc.	2021	5
K121393	Smith & Nephew, Inc. Total Knee System Instrumentation	Smith & Nephew, Inc.	2012	5
K230653	Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and…	Smith & Nephew, Inc.	2023	3

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jun 13, 2018	Class II	Z-0001-2019	Other	The data in the National Joint Registry of England, Wales and Northern Ireland (NJREWNI) and Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) indicate that the first generation JOURNEY BCS Knee System has a…
Jun 13, 2018	Class II	Z-0002-2019	Other	The data in the National Joint Registry of England, Wales and Northern Ireland (NJREWNI) and Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) indicate that the first generation JOURNEY BCS Knee System has a…
Jun 13, 2018	Class II	Z-0003-2019	Other	The data in the National Joint Registry of England, Wales and Northern Ireland (NJREWNI) and Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) indicate that the first generation JOURNEY BCS Knee System has a…

No ancestor or descendant has a Class I recall.

What does this lineage say?

3 of the 3 ancestors have a recall of any class.
Of its descendants, K071071 (Smith & Nephew, Inc., 2007) has gone furthest, with 66 descendants of its own.
31 other devices also cite its predicate K951987.

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?

Total knee components are indicated for rheumatoid arthritis; post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity level are compatible with an adequate long-term result; failed osteotomies, unicompartmental replacement, or total knee replacement. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are absent or incompetent and the collateral ligaments remain intact. Smith & Nephew, Inc. High Performance Knee components are indicated for use only with cement and are single use devices.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K042515 · printed Nov 6, 2026

Cite this page

510(k) Report. “K042515: Smith & Nephew, Inc. High Performance Knee.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042515

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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