510(k) · Cleared

Cleared

Smith & Newphew, Inc. Disposable Knee Instruments

K123159510(k) TraditionalCleared May 3, 2013206-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 May 3, 2013 as substantially equivalent to K093746 (Smith & Nephew, Inc., 2010) and 4 other predicates after a 206-day review. Its family tree reaches back 6 generations to 1995. 2 later devices descend from it.

Decided: May 3, 2013
Review: 206 days
Class: Class II
Product code: JWH
Recalls: None
Predicates: 5

Its longest line of descent runs back 6 generations to K951987 (1995). 44 ancestors in all, the oldest K853730 (1986). 2 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 6 generations backK951987 Genesis II Total Knee SystemSmith & Nephew Richards, Inc. · 1995 · Recalled
5 generations backK030612 Genesis II Total Knee SystemSmith & Nephew, Inc. · 2003
4 generations backK032295 Genesis II Posterior Stabilized High Flexion Articular InsertSmith & Nephew, Inc. · 2003 · Recalled
3 generations backK041825 Smith & Nephew Genesis II Deep Flexion Cruciate Retaining Articular…Smith & Nephew, Inc. · 2005
2 generations backK071071 Crosslinked Polyethylene Articular InsertsSmith & Nephew, Inc. · 2007 · Recalled
1 generation backK093746 Verilast Wear Claims for the Legion Primary Knee SystemSmith & Nephew, Inc. · 2010
This deviceK123159 Smith & Newphew, Inc. Disposable Knee InstrumentsSmith & Nephew, Inc. · 2013
Descendant · cites it directly · 0 of its ownK143226 Visionaire Disposable InstrumentsSmith & Nephew, Inc. · 2015
Descendant · cites it directly · 0 of its ownK141585 Smith & Nephew Disposable Fin PunchSmith & Nephew, Inc. · 2014

Most influential descendants

Showing 2 of 2 · See all

K143226Visionaire Disposable InstrumentsSmith & Nephew, Inc. · 2015 · cites it directly0descendants
K141585Smith & Nephew Disposable Fin PunchSmith & Nephew, Inc. · 2014 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−6	K951987	Genesis II Total Knee System	Smith & Nephew Richards, Inc.	1995	6
−5	K030612	Genesis II Total Knee System	Smith & Nephew, Inc.	2003	—
−4	K032295	Genesis II Posterior Stabilized High Flexion Articular Insert	Smith & Nephew, Inc.	2003	6
−3	K041825	Smith & Nephew Genesis II Deep Flexion Cruciate Retaining Articular Insert	Smith & Nephew, Inc.	2005	—
−2	K071071	Crosslinked Polyethylene Articular Inserts	Smith & Nephew, Inc.	2007	5
−1	K093746	Verilast Wear Claims for the Legion Primary Knee System	Smith & Nephew, Inc.	2010	—
0 (this device)	K123159	Smith & Newphew, Inc. Disposable Knee Instruments	Smith & Nephew, Inc.	2013	—
+1	K143226	Visionaire Disposable Instruments	Smith & Nephew, Inc.	2015	—
+1	K141585	Smith & Nephew Disposable Fin Punch	Smith & Nephew, Inc.	2014	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1986	1	0
1989	1	0
1994	2	0
1995	3	0
1996	6	0
1997	1	0
1998	1	0
1999	1	0
2000	1	0
2001	2	0
2002	4	0
2003	2	0
2004	2	0
2005	3	0
2006	2	0
2007	2	0
2008	1	0
2010	2	0
2012	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2014	1	0
2015	1	0

FIG. 1 — Lineage of K123159, 1995–2015Source: 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? (5)

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
*	K093746	Verilast Wear Claims for the Legion Primary Knee System Summary page 1 …Compatible Knee Systems Description 510(k) Clearance Date LEGION PRIMARY KNEE SYSTEM K093746 4/14/10 GENESIS 11TOTAL KNEE SYSTEM K951987 8/22/1995 GENESIS 11P/S HIGH FLE…	Smith & Nephew, Inc.	2010	—
*	K951987	Genesis II Total Knee System Summary page 1 …10(k) Clearance Date LEGION PRIMARY KNEE SYSTEM K093746 4/14/10 GENESIS 11TOTAL KNEE SYSTEM K951987 8/22/1995 GENESIS 11P/S HIGH FLEXION KNEE INSERT K032295 8/21/03 GENESIS 11DEEP FLEXION…	Smith & Nephew Richards, Inc.	1995	6
*	K032295	Genesis II Posterior Stabilized High Flexion Articular Insert Summary page 1 …K093746 4/14/10 GENESIS 11TOTAL KNEE SYSTEM K951987 8/22/1995 GENESIS 11P/S HIGH FLEXION KNEE INSERT K032295 8/21/03 GENESIS 11DEEP FLEXION C/R ARTICULAR INSERT K041825 3/11/05 TOTAL KNEE SYSTEM I…	Smith & Nephew, Inc.	2003	6
*	K041825	Smith & Nephew Genesis II Deep Flexion Cruciate Retaining Articular Insert Summary page 1 …K951987 8/22/1995 GENESIS 11P/S HIGH FLEXION KNEE INSERT K032295 8/21/03 GENESIS 11DEEP FLEXION C/R ARTICULAR INSERT K041825 3/11/05 TOTAL KNEE SYSTEM INSTRUMENTATION K121393 8/7/12 Summary o…	Smith & Nephew, Inc.	2005	—
*	K121393	Smith & Nephew, Inc. Total Knee System Instrumentation Summary page 1 …32295 8/21/03 GENESIS 11DEEP FLEXION C/R ARTICULAR INSERT K041825 3/11/05 TOTAL KNEE SYSTEM INSTRUMENTATION K121393 8/7/12 Summary of Safety and Effectiveness K123 159 (2/2) D…	Smith & Nephew, Inc.	2012	4

Also cleared against K093746: 2 other devices →

What descends from it? (2)

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

Number	Device	Applicant	Decided	Descendants
K143226	Visionaire Disposable Instruments	Smith & Nephew, Inc.	2015	0
K141585	Smith & Nephew Disposable Fin Punch	Smith & Nephew, Inc.	2014	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?

The line of descent spans 18 years and passes through 2 companies; a new generation was cleared every 2.6 years on median.
19 of the 44 ancestors have a recall of any class.
Of its descendants, K143226 (Smith & Nephew, Inc., 2015) has gone furthest, with 0 descendants of its own.
2 other devices also cite its predicate K093746.

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. 2013, 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?

Smith & Nephew Disposable Knee Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew, Inc. Genesis 11and Legions total knee systems and their cleared indications for use for Total Knee Replacement.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K123159 · printed Nov 6, 2026

Cite this page

510(k) Report. “K123159: Smith & Newphew, Inc. Disposable Knee Instruments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123159

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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