510(k) Report

510(k) · Cleared

Recalled · Class II · 2024

Legion Narrow Oxinium Cruciate Retaining and Posterior Stabilized Fenoral Components

K112941510(k) AbbreviatedCleared Dec 20, 201177-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 Dec 20, 2011 as substantially equivalent to K951987 (Smith & Nephew Richards, Inc., 1995) and 2 other predicates after a 77-day review. Its family tree reaches back 6 generations to 1995. 8 later devices descend from it. It has been recalled 3 times.

Decided
Dec 20, 2011
Review
77 days
Class
Class II
Product code
JWH
Recalls
3
Predicates
3

Its longest line of descent runs back 6 generations to K951987 (1995). 11 ancestors in all. 8 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1996: 3 other ancestors2005: 1 other ancestor1999: 1 other ancestor2017: 1 descendant cleared2023: 2 descendants cleared2014: 1 descendant cleared2015: 1 descendant cleared2024: 2 descendants cleared2026: 1 descendant clearedK951987 · Genesis II Total Knee System · Smith & Nephew Richards, Inc. · 1995 · recalled×2: 2 generations cleared close together, K030612 (2003), K032295 (2003) K041825 · Smith & Nephew Genesis II Deep Flexion Cruciate Retaining Articular Insert · Smith & Nephew, Inc. · 2005K071071 · Crosslinked Polyethylene Articular Inserts · Smith & Nephew, Inc. · 2007 · recalledK093746 · Verilast Wear Claims for the Legion Primary Knee System · Smith & Nephew, Inc. · 20101995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor3 generations back: 2 other ancestors4 generations back: 2 other ancestors 1 generation forward: 3 descendants2 generations forward: 5 descendants K093746 · Verilast Wear Claims for the Legion Primary Knee System · Smith & Nephew, Inc. · 2010K071071 · Crosslinked Polyethylene Articular Inserts · Smith & Nephew, Inc. · 2007 · recalledK041825 · Smith & Nephew Genesis II Deep Flexion Cruciate Retaining Articular Insert · Smith & Nephew, Inc. · 2005K032295 · Genesis II Posterior Stabilized High Flexion Articular Insert · Smith & Nephew, Inc. · 2003 · recalledK030612 · Genesis II Total Knee System · Smith & Nephew, Inc. · 2003K951987 · Genesis II Total Knee System · Smith & Nephew Richards, Inc. · 1995 · recalled−50
  1. Root · 6 generations backK951987 Genesis II Total Knee SystemSmith & Nephew Richards, Inc. · 1995 · Recalled
  2. 5 generations backK030612 Genesis II Total Knee SystemSmith & Nephew, Inc. · 2003
  3. 4 generations backK032295 Genesis II Posterior Stabilized High Flexion Articular InsertSmith & Nephew, Inc. · 2003 · Recalled
  4. 3 generations backK041825 Smith & Nephew Genesis II Deep Flexion Cruciate Retaining Articular…Smith & Nephew, Inc. · 2005
  5. 2 generations backK071071 Crosslinked Polyethylene Articular InsertsSmith & Nephew, Inc. · 2007 · Recalled
  6. 1 generation backK093746 Verilast Wear Claims for the Legion Primary Knee SystemSmith & Nephew, Inc. · 2010
  7. This deviceK112941 Legion Narrow Oxinium Cruciate Retaining and Posterior Stabilized…Smith & Nephew, Inc. · 2011
  8. Descendant · cites it directly · 7 of its ownK142807 ANTHEM PS Total Knee SystemSmith & Nephew, Inc. · 2014
  9. Descendant · cites it directly · 4 of its ownK170648 ANTHEM CR Total Knee SystemSmith & Nephew, Inc. · 2017
  10. Descendant · cites it directly · 3 of its ownK230653 Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee…Smith & Nephew, Inc. · 2023 · Recalled
  11. Descendant · 2 generations on · 0 of its ownK261462 LANDMARK Total Knee SystemSmith & Nephew, Inc. · 2026
  12. Descendant · 2 generations on · 0 of its ownK241260 ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc. · 2024

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2014: 12015: 12017: 12023: 22024: 22026: 1
2014high 2 (2023) · low 0 (2016)2026

Most influential descendants

Showing 5 of 8 · See all
  • K142807ANTHEM PS Total Knee SystemSmith & Nephew, Inc. · 2014 · cites it directly7descendants
  • K170648ANTHEM CR Total Knee SystemSmith & Nephew, Inc. · 2017 · cites it directly4descendants
  • K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and…Smith & Nephew, Inc. · 2023 · cites it directly3descendants
  • K261462LANDMARK Total Knee SystemSmith & Nephew, Inc. · 2026 · 2 generations on0descendants
  • K241260ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc. · 2024 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K951987Genesis II Total Knee SystemSmith & Nephew Richards, Inc.19956
−5K030612Genesis II Total Knee SystemSmith & Nephew, Inc.2003—
−4K032295Genesis II Posterior Stabilized High Flexion Articular InsertSmith & Nephew, Inc.20036
−3K041825Smith & Nephew Genesis II Deep Flexion Cruciate Retaining Articular InsertSmith & Nephew, Inc.2005—
−2K071071Crosslinked Polyethylene Articular InsertsSmith & Nephew, Inc.20075
−1K093746Verilast Wear Claims for the Legion Primary Knee SystemSmith & Nephew, Inc.2010—
0 (this device)K112941Legion Narrow Oxinium Cruciate Retaining and Posterior Stabilized Fenoral…Smith & Nephew, Inc.2011—
+1K142807ANTHEM PS Total Knee SystemSmith & Nephew, Inc.2014—
+1K170648ANTHEM CR Total Knee SystemSmith & Nephew, Inc.2017—
+1K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System…Smith & Nephew, Inc.20231
+2K261462LANDMARK Total Knee SystemSmith & Nephew, Inc.2026—
+2K241260ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc.2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199630
199910
200510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201410
201510
201710
202320
202420
202610
FIG. 1 — Lineage of K112941, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K221479 Persona Personalized Knee Systemscore 22.4 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #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.

TypeNumberDeviceApplicantDecidedRecalls
*K951987Genesis II Total Knee System
Summary page 2
…nce is based on similarities with regard to overall indications for use, material composition, and technological design characteristics. " Genesis 11Total Knee System - K951987 * Genesis 11and Profix Zirconium Femoral Components - K962557 " Legion Primary Knee System - K093746 Preclinical Testing: To fu…
Smith & Nephew Richards, Inc.19956
*K962557Genesis II Zirconium Femoral Component/Profix Zirconium Femoral Component
Summary page 2
…s for use, material composition, and technological design characteristics. " Genesis 11Total Knee System - K951987 * Genesis 11and Profix Zirconium Femoral Components - K962557 " Legion Primary Knee System - K093746 Preclinical Testing: To further support a determination of substantial equivalence, vari…
Smith & Nephew Richards, Inc.19961
*K093746Verilast Wear Claims for the Legion Primary Knee System
Summary page 2
…chnological design characteristics. " Genesis 11Total Knee System - K951987 * Genesis 11and Profix Zirconium Femoral Components - K962557 " Legion Primary Knee System - K093746 Preclinical Testing: To further support a determination of substantial equivalence, various types of pre-clinical testing were…
Smith & Nephew, Inc.2010—

Also cleared against K951987: 31 other devices →

What descends from it? (8)

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

NumberDeviceApplicantDecidedDescendants
K142807ANTHEM PS Total Knee SystemSmith & Nephew, Inc.20147
K170648ANTHEM CR Total Knee SystemSmith & Nephew, Inc.20174
K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and…Smith & Nephew, Inc.20233

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

Recalls of this device

DateClassRecallRoot causeReason
Oct 2, 2024Class IIZ-0282-2025Packaging change controlComplaint received indicating that a package contained a LEGION NARROW PS OXIN SZ 5N RIGHT implant instead of a GENESIS II POSTERIOR STABILIZED FEMORAL SIZE 5 LEFT as described on the product label.
Aug 31, 2023Class IIZ-2621-2023Labeling Change ControlThe firm conducting a recall due to a complaint received indicating that a package contained a LEGION NARROW PS OXIN SZ 4N LT implant instead of a LEGION NARROW PSvOXIN SZ 5N LT as described on the product label.
Apr 19, 2022Class IIZ-1099-2022Nonconforming Material/ComponentIt was reported that a JOURNEY II BCS Femoral OXIN LT SZ5 was in a box labelled as a LEGION NARROW PS OXIN SZ 6N RT.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 16 years and passes through 2 companies; a new generation was cleared every 2.5 years on median.
  • 7 of the 11 ancestors have a recall of any class.
  • Of its descendants, K142807 (Smith & Nephew, Inc., 2014) has gone furthest, with 7 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. 2011, this device’s year, is highlighted.

FDA decisions per year · JWH

20in 2025

2007: 182008: 172009: 112010: 192011: 252012: 332013: 312014: 332015: 272016: 182017: 252018: 252019: 282020: 222021: 242022: 172023: 202024: 192025: 202026 (partial year): 12
2007high 33 (2012) · low 11 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JWH

55in 2025

2007: 74 days median2008: 81 days median2009: 168 days median2010: 85 days median2011: 87 days median2012: 85 days median2013: 128 days median2014: 98 days median2015: 87 days median2016: 88 days median2017: 118 days median2018: 90 days median2019: 133 days median2020: 59 days median2021: 61 days median2022: 56 days median2023: 57 days median2024: 89 days median2025: 55 days median2026 (partial year): 63 days median
2007high 168 (2009) · low 55 (2025)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JWH

2in 2025

2007: 142008: 102009: 1092010: 322011: 272012: 852013: 312014: 132015: 112016: 172017: 612018: 142019: 52020: 22021: 82022: 122023: 672024: 72025: 22026 (partial year): 4
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

2007: 1,3052008: 1,4832009: 1,8702010: 3,2862011: 5,1332012: 5,2032013: 6,1352014: 6,7222015: 6,8812016: 7,5862017: 12,2632018: 14,0712019: 14,9872020: 12,5922021: 9,4082022: 8,3642023: 8,9472024: 10,8282025: 9,306
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071874141,305
20081781101,483
2009111681091,870
20101985323,286
20112587275,133
20123385855,203
201331128316,135
20143398136,722
20152787116,881
20161888177,586
2017251186112,263
201825901414,071
201928133514,987
20202259212,592
2021246189,408
20221756128,364
20232057678,947
20241989710,828
2025205529,306
202612634—

What is it indicated for?

Total knee components are indicated for rheumatoid arthritis; post-traumatic arthritis, osteoarthritis, or degenerative arthritis; 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 incompetent and the collateral ligaments remain intact.

Smith & Nephew, Inc. Legion Narrow Oxinium CR and P/S Femoral Components are indicated for use only with cement and are single use only devices.

Indications for use as stated in the FDA summary.

Also cleared against K951987

31 other devices cite the same predicate.

  • K261462LANDMARK Total Knee SystemSmith & Nephew, Inc. · 2026
  • K221939Cemented Round Patella with JRNY PegsSmith & Nephew, Inc. · 2022
  • K211221Porous Patella and Porous Tibia BaseplateSmith & Nephew, Inc. · 2021
  • K202924LinkSymphoKnee SystemWaldemar Link GmbH & Co. KG · 202111 recalls
  • K170648ANTHEM CR Total Knee SystemSmith & Nephew, Inc. · 2017
  • K162775Legion Cone SystemSmith & Nephew, Inc. · 20172 recalls

More from Smith & Nephew, Inc.

692 FDA decisions under this applicant name. See the company

  • K263348Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one ULTRABRAID Suture, Blue; Q-FIX KNOTLESS All-Suture Anchor…Smith & Nephew, Inc. · 2026
  • K261462LANDMARK Total Knee SystemSmith & Nephew, Inc. · 2026
  • K261968Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981)…Smith & Nephew, Inc. · 2026
  • DEN250037TESSA Spatial Surgery System; INTELLIO Tablet (72205455)Smith & Nephew, Inc. · 2026
  • K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc. · 2026

Recent decisions in JWH

The JWH category page

  • K262057GMK ExtensionMedacta International SA · 2026
  • K260063GSPE SpacerThe General Hospital Corporation, d/b/a Massachusetts · 2026
  • K262293EVOLUTION MPX™ Total Knee SystemSuzhou Microport Orthorecon Co., Ltd. · 2026
  • K262341b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem…B-One Ortho, Corp. · 2026
  • K262130ATTUNE Revision Knee SystemDepuy Orthopaedics, Inc. · 2026

https://510kreport.com/device/K112941 · printed Nov 4, 2026

Cite this page

510(k) Report. “K112941: Legion Narrow Oxinium Cruciate Retaining and Posterior Stabilized Fenoral Components.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K112941

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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