510(k) Report

510(k) · Cleared

Cleared

Genesis Porous Tibial Trays & Revision Knee System

K953274510(k) TraditionalCleared Feb 5, 1996206-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 Richards, Inc. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Cleared on Feb 5, 1996 after a 206-day review. The FDA summary names its predicate without a number. 161 later devices descend from it.

Decided
Feb 5, 1996
Review
206 days
Class
Class II
Product code
JWH
Recalls
None
Predicates
0

161 later devices descend from it, 9 citing it directly.

Descendants, by year cleared 2021: 12 descendants cleared2003: 3 descendants cleared2012: 7 descendants cleared2011: 6 descendants cleared2005: 4 descendants cleared2013: 8 descendants cleared2019: 10 descendants cleared2014: 8 descendants cleared2004: 2 descendants cleared2007: 2 descendants cleared2026: 14 descendants cleared2017: 5 descendants cleared2010: 5 descendants cleared2015: 12 descendants cleared2018: 6 descendants cleared2023: 9 descendants cleared2006: 5 descendants cleared2022: 10 descendants cleared2008: 1 descendant cleared2020: 6 descendants cleared2009: 1 descendant cleared2024: 12 descendants cleared2016: 2 descendants cleared2025: 11 descendants cleared1995200020052010201520202025
  1. This deviceK953274 Genesis Porous Tibial Trays & Revision Knee SystemSmith & Nephew Richards, Inc. · 1996
  2. Descendant · cites it directly · 141 of its ownK030612 Genesis II Total Knee SystemSmith & Nephew, Inc. · 2003
  3. Descendant · cites it directly · 76 of its ownK032295 Genesis II Posterior Stabilized High Flexion Articular InsertSmith & Nephew, Inc. · 2003 · Recalled
  4. Descendant · cites it directly · 75 of its ownK041825 Smith & Nephew Genesis II Deep Flexion Cruciate Retaining Articular…Smith & Nephew, Inc. · 2005
  5. Descendant · 2 generations on · 66 of its ownK071071 Crosslinked Polyethylene Articular InsertsSmith & Nephew, Inc. · 2007 · Recalled
  6. Descendant · 2 generations on · 60 of its ownK033489 Agc Total Knee System Knee, Ascent Total Knee System, Maxim Complete…Biomet, Inc. · 2004

Showing 5 of 161 descendants. See all descendants

Descendants cleared per year

2003: 32004: 22005: 42006: 52007: 22008: 12009: 12010: 52011: 62012: 72013: 82014: 82015: 122016: 22017: 52018: 62019: 102020: 62021: 122022: 102023: 92024: 122025: 112026: 14
2003high 14 (2026) · low 1 (2008)2026

Most influential descendants

Showing 5 of 161 · See all
  • K030612Genesis II Total Knee SystemSmith & Nephew, Inc. · 2003 · cites it directly141descendants
  • K032295Genesis II Posterior Stabilized High Flexion Articular InsertSmith & Nephew, Inc. · 2003 · cites it directly76descendants
  • K041825Smith & Nephew Genesis II Deep Flexion Cruciate Retaining Articular InsertSmith & Nephew, Inc. · 2005 · cites it directly75descendants
  • K071071Crosslinked Polyethylene Articular InsertsSmith & Nephew, Inc. · 2007 · 2 generations on66descendants
  • K033489Agc Total Knee System Knee, Ascent Total Knee System, Maxim Complete Knee System, Maxim…Biomet, Inc. · 2004 · 2 generations on60descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K953274Genesis Porous Tibial Trays & Revision Knee SystemSmith & Nephew Richards, Inc.1996—
+1K030612Genesis II Total Knee SystemSmith & Nephew, Inc.2003—
+1K032295Genesis II Posterior Stabilized High Flexion Articular InsertSmith & Nephew, Inc.20036
+1K041825Smith & Nephew Genesis II Deep Flexion Cruciate Retaining Articular InsertSmith & Nephew, Inc.2005—
+2K071071Crosslinked Polyethylene Articular InsertsSmith & Nephew, Inc.20075
+2K033489Agc Total Knee System Knee, Ascent Total Knee System, Maxim Complete Knee…Biomet, Inc.2004—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200330
200420
200540
200650
200720
200810
200910
201050
201160
201270
201380
201480
2015120
201620
201750
201860
2019100
202060
2021120
2022100
202390
2024120
2025110
2026140
FIG. 1 — Lineage of K953274, 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? (8)

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
*—Genesis I Total Knee System
Named without a submission number
—
*—NexGen Knee System
Named without a submission number
—
*—R.F.C. Modular Knee System
Named without a submission number
—
*—Whiteside Ortholoc II Modular Knee System
Named without a submission number
—
*—AMK/Coordinate Knee System
Named without a submission number
—
*—Advantim Knee System
Named without a submission number
—
*—Kinemax Plus Stabilizer Knee System
Named without a submission number
—
*—S-ROM Modular Knee System
Named without a submission number
—

What descends from it? (161)

See all 161

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

NumberDeviceApplicantDecidedDescendants
K030612Genesis II Total Knee SystemSmith & Nephew, Inc.2003141
K032295Genesis II Posterior Stabilized High Flexion Articular InsertSmith & Nephew, Inc.200376
K041825Smith & Nephew Genesis II Deep Flexion Cruciate Retaining Articular InsertSmith & Nephew, Inc.200575
K043440Smith & Nephew, Inc. Revision Knee SystemSmith & Nephew, Inc.200531
K211221Porous Patella and Porous Tibia BaseplateSmith & Nephew, Inc.20215
K121393Smith & Nephew, Inc. Total Knee System InstrumentationSmith & Nephew, Inc.20125
K202924LinkSymphoKnee SystemWaldemar Link GmbH & Co. KG20212
K131310GMK Full PE Tibial ComponentsMedacta International20132
K100370Symmetric Total Knee AgumentsSignal Medical Corp.20110

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?

  • Of its descendants, K030612 (Smith & Nephew, Inc., 2003) has gone furthest, with 141 descendants of its own.

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 Genesis II Revision System is used for primary and revision surgeries with the following indications 1. Rheumatoid arthritis. 2. 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. 4. The posterior stabilized knee system is designed for use in patients in…

Read the full statement (101 words)

The Genesis II Revision System is used for primary and revision surgeries with the following indications

1. Rheumatoid arthritis.

2. 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.

4. The posterior stabilized knee system is 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.

The Genesis I Total Knee System is indicated tor use only with cement and is a single use device.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Smith & Nephew Richards, Inc.

93 FDA decisions under this applicant name. See the company

  • P810020/S005OsteopalSmith & Nephew Richards, Inc. · 1998
  • P810020/S004Palacos E-Flow (Osteopal) Bone CementSmith & Nephew Richards, Inc. · 1998
  • K965224Empower Anterior Direct ScrewsSmith & Nephew Richards, Inc. · 1997
  • K963509Global Taper Tapered Hip System, GT SpectronSmith & Nephew Richards, Inc. · 1997
  • K960444Finn Rod to Rod ConnectorSmith & Nephew Richards, Inc. · 1997

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/K953274 · printed Nov 4, 2026

Cite this page

510(k) Report. “K953274: Genesis Porous Tibial Trays & Revision Knee System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K953274

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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