510(k) Report

510(k) · Cleared

Recalled · Class II · 2017

Revision Knee System

K041106510(k) SpecialCleared Jul 1, 200464-day reviewClass II21 CFR 888.3560Recalls 1

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 Jul 1, 2004 as substantially equivalent to K962137 (Smith & Nephew Richards, Inc., 1996) after a 64-day review. Its family tree reaches back 1 generation to 1996. 32 later devices descend from it. It has been recalled once.

Decided
Jul 1, 2004
Review
64 days
Class
Class II
Product code
JWH
Recalls
1
Predicates
1

Its longest line of descent runs back 1 generation to K962137 (1996). 32 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 2023: 2 descendants cleared2021: 2 descendants cleared2012: 3 descendants cleared2006: 3 descendants cleared2005: 2 descendants cleared2015: 3 descendants cleared2018: 1 descendant cleared2011: 2 descendants cleared2010: 1 descendant cleared2017: 1 descendant cleared2013: 1 descendant cleared2014: 1 descendant cleared2022: 1 descendant cleared2024: 2 descendants cleared2026: 1 descendant cleared2019: 2 descendants cleared2020: 1 descendant cleared2025: 3 descendants clearedK962137 · Genesis II Constrained System · Smith & Nephew Richards, Inc. · 1996 · recalled1995200020052010201520202025
Descendants, by generation 1 generation forward: 5 descendants2 generations forward: 15 descendants3 generations forward: 6 descendants4 generations forward: 4 descendants5 generations forward: 2 descendants K962137 · Genesis II Constrained System · Smith & Nephew Richards, Inc. · 1996 · recalled0+5
  1. Root · 1 generation backK962137 Genesis II Constrained SystemSmith & Nephew Richards, Inc. · 1996 · Recalled
  2. This deviceK041106 Revision Knee SystemSmith & Nephew, Inc. · 2004
  3. Descendant · cites it directly · 31 of its ownK043440 Smith & Nephew, Inc. Revision Knee SystemSmith & Nephew, Inc. · 2005 · Recalled
  4. Descendant · cites it directly · 10 of its ownK060742 Legion Cobalt Chrome Revision Knee SystemSmith & Nephew, Inc. · 2006 · Recalled
  5. Descendant · cites it directly · 5 of its ownK121393 Smith & Nephew, Inc. Total Knee System InstrumentationSmith & Nephew, Inc. · 2012 · Recalled
  6. Descendant · 2 generations on · 5 of its ownK053390 Columbus (CR) Total Knee SystemAesculap, Inc. · 2006 · Recalled
  7. Descendant · 2 generations on · 4 of its ownK180334 LEGION Knee SystemSmith & Nephew, Inc. · 2018

Showing 5 of 32 descendants. See all descendants

Descendants cleared per year

2005: 22006: 32010: 12011: 22012: 32013: 12014: 12015: 32017: 12018: 12019: 22020: 12021: 22022: 12023: 22024: 22025: 32026: 1
2005high 3 (2006) · low 0 (2007)2026

Most influential descendants

Showing 5 of 32 · See all
  • K043440Smith & Nephew, Inc. Revision Knee SystemSmith & Nephew, Inc. · 2005 · cites it directly31descendants
  • K060742Legion Cobalt Chrome Revision Knee SystemSmith & Nephew, Inc. · 2006 · cites it directly10descendants
  • K121393Smith & Nephew, Inc. Total Knee System InstrumentationSmith & Nephew, Inc. · 2012 · cites it directly5descendants
  • K053390Columbus (CR) Total Knee SystemAesculap, Inc. · 2006 · 2 generations on5descendants
  • K180334LEGION Knee SystemSmith & Nephew, Inc. · 2018 · 2 generations on4descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K962137Genesis II Constrained SystemSmith & Nephew Richards, Inc.19961
0 (this device)K041106Revision Knee SystemSmith & Nephew, Inc.2004—
+1K043440Smith & Nephew, Inc. Revision Knee SystemSmith & Nephew, Inc.20057
+1K060742Legion Cobalt Chrome Revision Knee SystemSmith & Nephew, Inc.20063
+1K121393Smith & Nephew, Inc. Total Knee System InstrumentationSmith & Nephew, Inc.20124
+2K053390Columbus (CR) Total Knee SystemAesculap, Inc.20061
+2K180334LEGION Knee SystemSmith & Nephew, Inc.2018—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200520
200630
201010
201120
201230
201310
201410
201530
201710
201810
201920
202010
202120
202210
202320
202420
202530
202610
FIG. 1 — Lineage of K041106, 1996–2026Source: 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K962137Genesis II Constrained System
Summary page 1
…y and are intended for implantation with bone cement. These indications are the same as currently used for the Genesis IIConstrained Knee System cleared via K962137. B. DEVICE DESCRIPTION: The Revision Femoral Knee Components are manufactured from Oxinium. Wedges and screws are…
Smith & Nephew Richards, Inc.19961
*—Genesis II Total Knee System
Named without a submission number
—

Also cleared against K962137: 5 other devices →

What descends from it? (32)

See all 32

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

NumberDeviceApplicantDecidedDescendants
K043440Smith & Nephew, Inc. Revision Knee SystemSmith & Nephew, Inc.200531
K060742Legion Cobalt Chrome Revision Knee SystemSmith & Nephew, Inc.200610
K121393Smith & Nephew, Inc. Total Knee System InstrumentationSmith & Nephew, Inc.20125
K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and…Smith & Nephew, Inc.20233
K202924LinkSymphoKnee SystemWaldemar Link GmbH & Co. KG20212

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

Recalls of this device

DateClassRecallRoot causeReason
Sep 14, 2017Class IIZ-0092-2018Mixed-up of materials/componentsThe Legion Screw-on Wedge Size 4 contained 5MM screws instead of the required 10MM screw.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has a recall.
  • Of its descendants, K043440 (Smith & Nephew, Inc., 2005) has gone furthest, with 31 descendants of its own.
  • 5 other devices also cite its predicate K962137.

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

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?

The Revision Knee System Components are indicated for rheumatoid arthritis; post-traumatic arthritis; osteoarthritis; degenerative arthritis; and failed osteotomies, hemiarthroplasties; unicompartmental replacement; or total knee arthroplasties. The components are designed for use in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral and/or lateral collateral ligament) are absent or incompetent.

The Revision Knee Components are for single use only and are intended for implantation with bone cement.

Indications for use as stated in the FDA summary.

Also cleared against K962137

5 other devices cite the same predicate.

  • K220896Legion Inserts with JRNY LockSmith & Nephew, Inc. · 2022
  • K160515PS2 Knee SystemConsensus Orthopedics, Inc. · 2016
  • K121393Smith & Nephew, Inc. Total Knee System InstrumentationSmith & Nephew, Inc. · 20124 recalls
  • K071071Crosslinked Polyethylene Articular InsertsSmith & Nephew, Inc. · 20075 recalls
  • K043440Smith & Nephew, Inc. Revision Knee SystemSmith & Nephew, Inc. · 20057 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/K041106 · printed Nov 5, 2026

Cite this page

510(k) Report. “K041106: Revision Knee System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041106

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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