510(k) Report

510(k) · Cleared

Cleared

Optetrak Total Knee System Asymmetric Femoral Components Size 6 Psoterior-Stabilizing, Cemented Femoral Components

K032606510(k) SpecialCleared Sep 23, 200329-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

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

Cleared on Sep 23, 2003 as substantially equivalent to K932690 (Exactech, Inc., 1995) and 3 other predicates after a 29-day review. Its family tree reaches back 2 generations to 1994. 18 later devices descend from it.

Decided
Sep 23, 2003
Review
29 days
Class
Class II
Product code
JWH
Recalls
None
Predicates
4

Its longest line of descent runs back 2 generations to K936079 (1994). 8 ancestors in all. 18 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1995: 3 other ancestors1994: 2 other ancestors1996: 1 other ancestor2004: 1 descendant cleared2010: 1 descendant cleared2007: 1 descendant cleared2016: 2 descendants cleared2011: 2 descendants cleared2015: 2 descendants cleared2013: 3 descendants cleared2012: 1 descendant cleared2014: 1 descendant cleared2023: 1 descendant cleared2017: 2 descendants cleared2018: 1 descendant clearedK936079 · Ecactech Porous Coated Finned Tibial Tray Compnent · Exactech, Inc. · 1994K011976 · Optetrak Total Knee System Size 0/1 Delta (Line Extension) · Exactech, Inc. · 20011990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 3 other ancestors 1 generation forward: 2 descendants2 generations forward: 8 descendants3 generations forward: 7 descendants4 generations forward: 1 descendant K011976 · Optetrak Total Knee System Size 0/1 Delta (Line Extension) · Exactech, Inc. · 2001K936079 · Ecactech Porous Coated Finned Tibial Tray Compnent · Exactech, Inc. · 19940
  1. Root · 2 generations backK936079 Ecactech Porous Coated Finned Tibial Tray CompnentExactech, Inc. · 1994
  2. 1 generation backK011976 Optetrak Total Knee System Size 0/1 Delta (Line Extension)Exactech, Inc. · 2001
  3. This deviceK032606 Optetrak Total Knee System Asymmetric Femoral Components Size 6…Exactech, Inc. · 2003
  4. Descendant · cites it directly · 17 of its ownK033883 Optetrak Total Knee System, HI-Flex Asymmetric Posterior-Stabilized…Exactech, Inc. · 2004 · Recalled
  5. Descendant · cites it directly · 15 of its ownK093360 Optetrak Logic Total Knee System Trapezoidal Tibial Tray, Sizes…Exactech, Inc. · 2010 · Recalled
  6. Descendant · 2 generations on · 12 of its ownK111400 Optetrak Logic CR Tibial Insert, Optetrak Logic CR Femoral ComponentExactech, Inc. · 2011 · Recalled
  7. Descendant · 3 generations on · 11 of its ownK121307 Optetrak Logic CR Tibial Insert, Size 0 Optetrak Logic CR Tibial…Exactech, Inc. · 2012
  8. Descendant · 2 generations on · 7 of its ownK123687 Optetrak Logic Porous Femoral ComponentExactech, Inc. · 2013

Showing 5 of 18 descendants. See all descendants

Descendants cleared per year

2004: 12007: 12010: 12011: 22012: 12013: 32014: 12015: 22016: 22017: 22018: 12023: 1
2004high 3 (2013) · low 0 (2005)2026

Most influential descendants

Showing 5 of 18 · See all
  • K033883Optetrak Total Knee System, HI-Flex Asymmetric Posterior-Stabilized Cemented Femoral…Exactech, Inc. · 2004 · cites it directly17descendants
  • K093360Optetrak Logic Total Knee System Trapezoidal Tibial Tray, Sizes 2.5F/1.5T-3.5F/4.5TExactech, Inc. · 2010 · cites it directly15descendants
  • K111400Optetrak Logic CR Tibial Insert, Optetrak Logic CR Femoral ComponentExactech, Inc. · 2011 · 2 generations on12descendants
  • K121307Optetrak Logic CR Tibial Insert, Size 0 Optetrak Logic CR Tibial Insert, Size 6 Optetrak…Exactech, Inc. · 2012 · 3 generations on11descendants
  • K123687Optetrak Logic Porous Femoral ComponentExactech, Inc. · 2013 · 2 generations on7descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K936079Ecactech Porous Coated Finned Tibial Tray CompnentExactech, Inc.1994—
−1K011976Optetrak Total Knee System Size 0/1 Delta (Line Extension)Exactech, Inc.2001—
0 (this device)K032606Optetrak Total Knee System Asymmetric Femoral Components Size 6…Exactech, Inc.2003—
+1K033883Optetrak Total Knee System, HI-Flex Asymmetric Posterior-Stabilized Cemented…Exactech, Inc.20043
+1K093360Optetrak Logic Total Knee System Trapezoidal Tibial Tray, Sizes…Exactech, Inc.20102
+2K111400Optetrak Logic CR Tibial Insert, Optetrak Logic CR Femoral ComponentExactech, Inc.20111
+3K121307Optetrak Logic CR Tibial Insert, Size 0 Optetrak Logic CR Tibial Insert, Size…Exactech, Inc.2012—
+2K123687Optetrak Logic Porous Femoral ComponentExactech, Inc.2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199420
199530
199610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200710
201010
201120
201210
201330
201410
201520
201620
201720
201810
202310
FIG. 1 — Lineage of K032606, 1994–2023Source: 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? (4)

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
*K932690Exactech Cruciate Retaining Cemented Total Knee SY
Summary page 2
…bstantial Equivalence Comparison: Model 5 1O(k) Number Optetrak@Cruciate Retaining Cemented Femoral Component K932690 Optetrak@Posterior Stabilizing Cemented Femoral Component K933494 Optetrak@Cruciate Re:tainingPorous-Coated Femoral Component K…
Exactech, Inc.19956
*K933494Exactech Posterior Stabilized Cemented Total Knee System
Summary page 2
…5 1O(k) Number Optetrak@Cruciate Retaining Cemented Femoral Component K932690 Optetrak@Posterior Stabilizing Cemented Femoral Component K933494 Optetrak@Cruciate Re:tainingPorous-Coated Femoral Component K935726 Optetrak@Size 0 and ]I Delta Line Extension K…
Exactech, Inc.19952
*K935726Exactech Porous Coated Cruciate Retained Femoral Component
Summary page 2
…g Cemented Femoral Component K932690 Optetrak@Posterior Stabilizing Cemented Femoral Component K933494 Optetrak@Cruciate Re:tainingPorous-Coated Femoral Component K935726 Optetrak@Size 0 and ]I Delta Line Extension KO1 1976 Device Information: INTENDED USE The Optetrak@Femoral com…
Exactech, Inc.1994—
*K011976Optetrak Total Knee System Size 0/1 Delta (Line Extension)Exactech, Inc.2001—

Also cleared against K932690: 5 other devices →

What descends from it? (18)

See all 18

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

NumberDeviceApplicantDecidedDescendants
K033883Optetrak Total Knee System, HI-Flex Asymmetric Posterior-Stabilized Cemented Femoral…Exactech, Inc.200417
K093360Optetrak Logic Total Knee System Trapezoidal Tibial Tray, Sizes 2.5F/1.5T-3.5F/4.5TExactech, Inc.201015

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?

  • The line of descent spans 9 years and passes through 1 company; a new generation was cleared every 6.9 years on median.
  • 5 of the 8 ancestors have a recall of any class.
  • Of its descendants, K033883 (Exactech, Inc., 2004) has gone furthest, with 17 descendants of its own.
  • 5 other devices also cite its predicate K932690.

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 OPTETRAK@Total Knee Systems are indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis andor post-traumatic degenerative problems. They are also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.

Indications for use as stated in the FDA summary.

Also cleared against K932690

5 other devices cite the same predicate.

  • K223252TRULIANT® E-PX Tibial Inserts; TRULIANT® E-PX PatellasExactech, Inc. · 20231 recall
  • K111400Optetrak Logic CR Tibial Insert, Optetrak Logic CR Femoral ComponentExactech, Inc. · 20111 recall
  • K100900Motivation Knee SystemEncore Medical L.P. · 20104 recalls
  • K082022Optetrak 9MM Cruciate Retaining Tibial Insert, Slope ++Exactech, Inc. · 2008
  • K011976Optetrak Total Knee System Size 0/1 Delta (Line Extension)Exactech, Inc. · 2001

More from Exactech, Inc.

207 FDA decisions under this applicant name. See the company

  • K260583Equinoxe® Shoulder SystemExactech, Inc. · 2026
  • 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/K032606 · printed Nov 3, 2026

Cite this page

510(k) Report. “K032606: Optetrak Total Knee System Asymmetric Femoral Components Size 6 Psoterior-Stabilizing, Cemented Femoral Components.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K032606

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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