510(k) Report

510(k) · Cleared

Recalled · Class II · 2023

Optetrak Constrained Condylar Knee for Cemented Use Only

K954208510(k) TraditionalCleared Feb 26, 1996172-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

Exactech, Inc. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Cleared on Feb 26, 1996 after a 172-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 110 later devices descend from it. It has been recalled once.

Decided
Feb 26, 1996
Review
172 days
Class
Class II
Product code
JWH
Recalls
1
Predicates
0

110 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 2016: 12 descendants cleared2001: 2 descendants cleared2015: 5 descendants cleared2007: 1 descendant cleared2002: 1 descendant cleared2004: 1 descendant cleared2003: 2 descendants cleared2010: 2 descendants cleared2023: 10 descendants cleared2009: 1 descendant cleared2014: 9 descendants cleared2012: 4 descendants cleared2018: 4 descendants cleared2013: 8 descendants cleared2017: 6 descendants cleared2025: 9 descendants cleared2020: 5 descendants cleared2026: 2 descendants cleared2011: 2 descendants cleared2019: 4 descendants cleared2022: 5 descendants cleared2024: 1 descendant cleared2021: 14 descendants cleared1995200020052010201520202025
  1. This deviceK954208 Optetrak Constrained Condylar Knee for Cemented Use OnlyExactech, Inc. · 1996
  2. Descendant · cites it directly · 107 of its ownK011976 Optetrak Total Knee System Size 0/1 Delta (Line Extension)Exactech, Inc. · 2001
  3. Descendant · 2 generations on · 86 of its ownK030686 Optetrak Total Knee System - Molded Metal-Back Tibial ComponentExactech, Inc. · 2003
  4. Descendant · 2 generations on · 72 of its ownK100900 Motivation Knee SystemEncore Medical L.P. · 2010 · Recalled
  5. Descendant · 3 generations on · 35 of its ownK113756 Highly Cross Linked VE Central Peg Patella Highly Cross Linked VE…Encore Medical L.P. · 2012 · Recalled
  6. Descendant · 4 generations on · 33 of its ownK122870 Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. · 2013

Showing 5 of 110 descendants. See all descendants

Descendants cleared per year

2001: 22002: 12003: 22004: 12007: 12009: 12010: 22011: 22012: 42013: 82014: 92015: 52016: 122017: 62018: 42019: 42020: 52021: 142022: 52023: 102024: 12025: 92026: 2
2001high 14 (2021) · low 0 (2005)2026

Most influential descendants

Showing 5 of 110 · See all
  • K011976Optetrak Total Knee System Size 0/1 Delta (Line Extension)Exactech, Inc. · 2001 · cites it directly107descendants
  • K030686Optetrak Total Knee System - Molded Metal-Back Tibial ComponentExactech, Inc. · 2003 · 2 generations on86descendants
  • K100900Motivation Knee SystemEncore Medical L.P. · 2010 · 2 generations on72descendants
  • K113756Highly Cross Linked VE Central Peg Patella Highly Cross Linked VE Tri-Peg Patella Highly…Encore Medical L.P. · 2012 · 3 generations on35descendants
  • K122870Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. · 2013 · 4 generations on33descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K954208Optetrak Constrained Condylar Knee for Cemented Use OnlyExactech, Inc.1996—
+1K011976Optetrak Total Knee System Size 0/1 Delta (Line Extension)Exactech, Inc.2001—
+2K030686Optetrak Total Knee System - Molded Metal-Back Tibial ComponentExactech, Inc.2003—
+2K100900Motivation Knee SystemEncore Medical L.P.20104
+3K113756Highly Cross Linked VE Central Peg Patella Highly Cross Linked VE Tri-Peg…Encore Medical L.P.20121
+4K122870Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.2013—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200120
200210
200320
200410
200710
200910
201020
201120
201240
201380
201490
201550
2016120
201760
201840
201940
202050
2021140
202250
2023100
202410
202590
202620
FIG. 1 — Lineage of K954208, 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
Get a 510(k) Report

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? (110)

See all 110

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

NumberDeviceApplicantDecidedDescendants
K011976Optetrak Total Knee System Size 0/1 Delta (Line Extension)Exactech, Inc.2001107
K012251Optetrak Total Knee System, Straight Stem Extensions - Additional SizesExactech, Inc.20014
K150890Exactech Optetrak Logic CCExactech, Inc.20153
K160484Optetrak Advanced PatellaExactech, Inc.20161
K071738Exactech Optetrak Proximal Tibial SpacerExactech, Inc.20070

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

Recalls of this device

DateClassRecallRoot causeReason
Nov 21, 2023Class IIZ-0582-2024Packaging change controlExactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K011976 (Exactech, Inc., 2001) has gone furthest, with 107 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 Exactech, Inc.

207 FDA decisions under this applicant name. See the company

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  • K250713Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder ImplantsExactech, Inc. · 2025
  • K243448Equinoxe® Shoulder SystemExactech, Inc. · 2025
  • K243275Equinoxe® Scapula Fracture SystemExactech, Inc. · 2025
  • K243839Alteon® HA Femoral StemsExactech, Inc. · 2025

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/K954208 · printed Nov 4, 2026

Cite this page

510(k) Report. “K954208: Optetrak Constrained Condylar Knee for Cemented Use Only.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K954208

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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