510(k) · Cleared

Cleared

Verilast Wear Claims for the Legion Primary Knee System

K093746510(k) TraditionalCleared Apr 14, 2010131-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

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

Cleared on Apr 14, 2010 as substantially equivalent to K962557 (Smith & Nephew Richards, Inc., 1996) and 1 other predicate after a 131-day review. Its family tree reaches back 5 generations to 1995. 29 later devices descend from it.

Decided: Apr 14, 2010
Review: 131 days
Class: Class II
Product code: JWH
Recalls: None
Predicates: 2

Its longest line of descent runs back 5 generations to K951987 (1995). 10 ancestors in all. 29 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 5 generations backK951987 Genesis II Total Knee SystemSmith & Nephew Richards, Inc. · 1995 · Recalled
4 generations backK030612 Genesis II Total Knee SystemSmith & Nephew, Inc. · 2003
3 generations backK032295 Genesis II Posterior Stabilized High Flexion Articular InsertSmith & Nephew, Inc. · 2003 · Recalled
2 generations backK041825 Smith & Nephew Genesis II Deep Flexion Cruciate Retaining Articular…Smith & Nephew, Inc. · 2005
1 generation backK071071 Crosslinked Polyethylene Articular InsertsSmith & Nephew, Inc. · 2007 · Recalled
This deviceK093746 Verilast Wear Claims for the Legion Primary Knee SystemSmith & Nephew, Inc. · 2010
Descendant · cites it directly · 16 of its ownK142787 Zimmer Persona Personalized Knee SystemZimmer, Inc. · 2014
Descendant · 2 generations on · 15 of its ownK172524 Zimmer Persona Personalized Knee SystemZimmer, Inc. · 2018
Descendant · cites it directly · 8 of its ownK112941 Legion Narrow Oxinium Cruciate Retaining and Posterior Stabilized…Smith & Nephew, Inc. · 2011 · Recalled
Descendant · 2 generations on · 7 of its ownK142807 ANTHEM PS Total Knee SystemSmith & Nephew, Inc. · 2014
Descendant · 3 generations on · 6 of its ownK173890 GMK Sphere - Kinematic AlignmentMedacta International S.A. · 2018

Showing 5 of 29 descendants. See all descendants

Descendants cleared per year

2011high 5 (2023) · low 0 (2012)2026

Most influential descendants

Showing 5 of 29 · See all

K142787Zimmer Persona Personalized Knee SystemZimmer, Inc. · 2014 · cites it directly16descendants
K172524Zimmer Persona Personalized Knee SystemZimmer, Inc. · 2018 · 2 generations on15descendants
K112941Legion Narrow Oxinium Cruciate Retaining and Posterior Stabilized Fenoral ComponentsSmith & Nephew, Inc. · 2011 · cites it directly8descendants
K142807ANTHEM PS Total Knee SystemSmith & Nephew, Inc. · 2014 · 2 generations on7descendants
K173890GMK Sphere - Kinematic AlignmentMedacta International S.A. · 2018 · 3 generations on6descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−5	K951987	Genesis II Total Knee System	Smith & Nephew Richards, Inc.	1995	6
−4	K030612	Genesis II Total Knee System	Smith & Nephew, Inc.	2003	—
−3	K032295	Genesis II Posterior Stabilized High Flexion Articular Insert	Smith & Nephew, Inc.	2003	6
−2	K041825	Smith & Nephew Genesis II Deep Flexion Cruciate Retaining Articular Insert	Smith & Nephew, Inc.	2005	—
−1	K071071	Crosslinked Polyethylene Articular Inserts	Smith & Nephew, Inc.	2007	5
0 (this device)	K093746	Verilast Wear Claims for the Legion Primary Knee System	Smith & Nephew, Inc.	2010	—
+1	K142787	Zimmer Persona Personalized Knee System	Zimmer, Inc.	2014	—
+2	K172524	Zimmer Persona Personalized Knee System	Zimmer, Inc.	2018	—
+1	K112941	Legion Narrow Oxinium Cruciate Retaining and Posterior Stabilized Fenoral…	Smith & Nephew, Inc.	2011	3
+2	K142807	ANTHEM PS Total Knee System	Smith & Nephew, Inc.	2014	—
+3	K173890	GMK Sphere - Kinematic Alignment	Medacta International S.A.	2018	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1996	3	0
1999	1	0
2005	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	1	0
2013	1	0
2014	3	0
2015	2	0
2017	1	0
2018	2	0
2020	2	0
2022	2	0
2023	5	0
2024	4	0
2025	1	0
2026	5	0

FIG. 1 — Lineage of K093746, 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

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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
*	K962557	Genesis II Zirconium Femoral Component/Profix Zirconium Femoral Component Summary page 1 …ymer semi-constrained cemented prosthesis Device Class: Class 1I Panel Code: Orthopaedics/87 JWH Predicate Devices: Genesis 11& Profix Zirconium Femoral Knee Components 1K962557); and Crosslinked Polyethylene Articular Inserts (K071 071) Device Description Subject of this Traditional 5101k) Premarke…	Smith & Nephew Richards, Inc.	1996	1
*	K071071	Crosslinked Polyethylene Articular Inserts Summary page 1 …Panel Code: Orthopaedics/87 JWH Predicate Devices: Genesis 11& Profix Zirconium Femoral Knee Components 1K962557); and Crosslinked Polyethylene Articular Inserts (K071 071) Device Description Subject of this Traditional 5101k) Premarket Notification isa request for long-term in vitro wear claims for…	Smith & Nephew, Inc.	2007	5

Also cleared against K962557: 5 other devices →

What descends from it? (29)

See all 29

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

Number	Device	Applicant	Decided	Descendants
K142787	Zimmer Persona Personalized Knee System	Zimmer, Inc.	2014	16
K112941	Legion Narrow Oxinium Cruciate Retaining and Posterior Stabilized Fenoral Components	Smith & Nephew, Inc.	2011	8
K123159	Smith & Newphew, Inc. Disposable Knee Instruments	Smith & Nephew, Inc.	2013	2

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 15 years and passes through 2 companies; a new generation was cleared every 2.5 years on median.
7 of the 10 ancestors have a recall of any class.
Of its descendants, K142787 (Zimmer, Inc., 2014) has gone furthest, with 16 descendants of its own.
5 other devices also cite its predicate K962557.

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. 2010, 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?

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. Legion Primary 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/K093746 · printed Nov 6, 2026

Cite this page

510(k) Report. “K093746: Verilast Wear Claims for the Legion Primary 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/K093746

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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