510(k) Report

510(k) · Cleared

Cleared

Profix Posterior-Stabilized Knee System

K954909510(k) TraditionalCleared Jan 31, 199698-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 Jan 31, 1996 after a 98-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 79 later devices descend from it.

Decided
Jan 31, 1996
Review
98 days
Class
Class II
Product code
JWH
Recalls
None
Predicates
0

79 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2003: 1 descendant cleared2012: 3 descendants cleared2004: 2 descendants cleared2010: 2 descendants cleared2005: 1 descendant cleared2011: 1 descendant cleared2017: 3 descendants cleared2013: 5 descendants cleared2014: 4 descendants cleared2021: 8 descendants cleared2006: 2 descendants cleared2008: 1 descendant cleared2023: 3 descendants cleared2015: 5 descendants cleared2020: 3 descendants cleared2019: 5 descendants cleared2018: 3 descendants cleared2022: 2 descendants cleared2016: 2 descendants cleared2026: 8 descendants cleared2024: 9 descendants cleared2025: 6 descendants cleared1995200020052010201520202025
  1. This deviceK954909 Profix Posterior-Stabilized Knee SystemSmith & Nephew Richards, Inc. · 1996
  2. Descendant · cites it directly · 78 of its ownK030623 Smith & Nephew Profix Total Knee SystemSmith & Nephew, Inc. · 2003
  3. Descendant · 2 generations on · 60 of its ownK033489 Agc Total Knee System Knee, Ascent Total Knee System, Maxim Complete…Biomet, Inc. · 2004
  4. Descendant · 3 generations on · 47 of its ownK060303 Vanguard PS Open Box Porous Femoral ComponentsBiomet Manufacturing Corp · 2006
  5. Descendant · 3 generations on · 46 of its ownK113550 Vanguard Complete Knee SystemBiomet Manufacturing Corp · 2012 · Recalled
  6. Descendant · 2 generations on · 14 of its ownK051229 Profix Flex Cruciate Retaining Articular InsertSmith & Nephew, Inc. · 2005

Showing 5 of 79 descendants. See all descendants

Descendants cleared per year

2003: 12004: 22005: 12006: 22008: 12010: 22011: 12012: 32013: 52014: 42015: 52016: 22017: 32018: 32019: 52020: 32021: 82022: 22023: 32024: 92025: 62026: 8
2003high 9 (2024) · low 0 (2007)2026

Most influential descendants

Showing 5 of 79 · See all
  • K030623Smith & Nephew Profix Total Knee SystemSmith & Nephew, Inc. · 2003 · cites it directly78descendants
  • K033489Agc Total Knee System Knee, Ascent Total Knee System, Maxim Complete Knee System, Maxim…Biomet, Inc. · 2004 · 2 generations on60descendants
  • K060303Vanguard PS Open Box Porous Femoral ComponentsBiomet Manufacturing Corp · 2006 · 3 generations on47descendants
  • K113550Vanguard Complete Knee SystemBiomet Manufacturing Corp · 2012 · 3 generations on46descendants
  • K051229Profix Flex Cruciate Retaining Articular InsertSmith & Nephew, Inc. · 2005 · 2 generations on14descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K954909Profix Posterior-Stabilized Knee SystemSmith & Nephew Richards, Inc.1996—
+1K030623Smith & Nephew Profix Total Knee SystemSmith & Nephew, Inc.2003—
+2K033489Agc Total Knee System Knee, Ascent Total Knee System, Maxim Complete Knee…Biomet, Inc.2004—
+3K060303Vanguard PS Open Box Porous Femoral ComponentsBiomet Manufacturing Corp2006—
+3K113550Vanguard Complete Knee SystemBiomet Manufacturing Corp20127
+2K051229Profix Flex Cruciate Retaining Articular InsertSmith & Nephew, Inc.2005—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200420
200510
200620
200810
201020
201110
201230
201350
201440
201550
201620
201730
201830
201950
202030
202180
202220
202330
202490
202560
202680
FIG. 1 — Lineage of K954909, 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), 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
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (79)

See all 79

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

NumberDeviceApplicantDecidedDescendants
K030623Smith & Nephew Profix Total Knee SystemSmith & Nephew, Inc.200378
K121393Smith & Nephew, Inc. Total Knee System InstrumentationSmith & Nephew, Inc.20125

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, K030623 (Smith & Nephew, Inc., 2003) has gone furthest, with 78 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—

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

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  • 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/K954909 · printed Nov 4, 2026

Cite this page

510(k) Report. “K954909: Profix Posterior-Stabilized 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/K954909

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026