510(k) Report

510(k) · Cleared

Recalled · Class II · 2021

Optetrak Logic PS 17MM & 19MM Thick Inserts, Optetrak Logic PSC 17MM & 19MM Thick Inserts

K132161510(k) TraditionalCleared Oct 11, 201391-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 Oct 11, 2013 as substantially equivalent to K093360 (Exactech, Inc., 2010) and 6 other predicates after a 91-day review. Its family tree reaches back 8 generations to 1994. 3 later devices descend from it. It has been recalled once.

Decided
Oct 11, 2013
Review
91 days
Class
Class II
Product code
JWH
Recalls
1
Predicates
7

Its longest line of descent runs back 8 generations to K936079 (1994). 17 ancestors in all. 3 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2011: 1 other ancestor1995: 3 other ancestors1994: 2 other ancestors2008: 1 other ancestor2001: 1 other ancestor1996: 1 other ancestor2015: 1 descendant cleared2023: 1 descendant cleared2017: 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. · 2001K032606 · Optetrak Total Knee System Asymmetric Femoral Components Size 6 Psoterior-Stabilizing, Cemented Femoral Components · Exactech, Inc. · 2003K033883 · Optetrak Total Knee System, HI-Flex Asymmetric Posterior-Stabilized Cemented Femoral Components, HI-Flex Posterior-Stabi · Exactech, Inc. · 2004 · recalledK093360 · Optetrak Logic Total Knee System Trapezoidal Tibial Tray, Sizes 2.5F/1.5T-3.5F/4.5T · Exactech, Inc. · 2010 · recalledK111400 · Optetrak Logic CR Tibial Insert, Optetrak Logic CR Femoral Component · Exactech, Inc. · 2011 · recalledK121307 · Optetrak Logic CR Tibial Insert, Size 0 Optetrak Logic CR Tibial Insert, Size 6 Optetrak Logic CR Femoral Component, Siz · Exactech, Inc. · 2012K123342 · Optetrak Logic CRC Tibial Insert · Exactech, Inc. · 20131990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 3 other ancestors3 generations back: 2 other ancestors4 generations back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 2 descendants K123342 · Optetrak Logic CRC Tibial Insert · Exactech, Inc. · 2013K121307 · Optetrak Logic CR Tibial Insert, Size 0 Optetrak Logic CR Tibial Insert, Size 6 Optetrak Logic CR Femoral Component, Siz · Exactech, Inc. · 2012K111400 · Optetrak Logic CR Tibial Insert, Optetrak Logic CR Femoral Component · Exactech, Inc. · 2011 · recalledK093360 · Optetrak Logic Total Knee System Trapezoidal Tibial Tray, Sizes 2.5F/1.5T-3.5F/4.5T · Exactech, Inc. · 2010 · recalledK033883 · Optetrak Total Knee System, HI-Flex Asymmetric Posterior-Stabilized Cemented Femoral Components, HI-Flex Posterior-Stabi · Exactech, Inc. · 2004 · recalledK032606 · Optetrak Total Knee System Asymmetric Femoral Components Size 6 Psoterior-Stabilizing, Cemented Femoral Components · Exactech, Inc. · 2003K011976 · Optetrak Total Knee System Size 0/1 Delta (Line Extension) · Exactech, Inc. · 2001K936079 · Ecactech Porous Coated Finned Tibial Tray Compnent · Exactech, Inc. · 1994−50
  1. Root · 8 generations backK936079 Ecactech Porous Coated Finned Tibial Tray CompnentExactech, Inc. · 1994
  2. 7 generations backK011976 Optetrak Total Knee System Size 0/1 Delta (Line Extension)Exactech, Inc. · 2001
  3. 6 generations backK032606 Optetrak Total Knee System Asymmetric Femoral Components Size 6…Exactech, Inc. · 2003
  4. 5 generations backK033883 Optetrak Total Knee System, HI-Flex Asymmetric Posterior-Stabilized…Exactech, Inc. · 2004 · Recalled
  5. 4 generations backK093360 Optetrak Logic Total Knee System Trapezoidal Tibial Tray, Sizes…Exactech, Inc. · 2010 · Recalled
  6. 3 generations backK111400 Optetrak Logic CR Tibial Insert, Optetrak Logic CR Femoral ComponentExactech, Inc. · 2011 · Recalled
  7. 2 generations backK121307 Optetrak Logic CR Tibial Insert, Size 0 Optetrak Logic CR Tibial…Exactech, Inc. · 2012
  8. 1 generation backK123342 Optetrak Logic CRC Tibial InsertExactech, Inc. · 2013
  9. This deviceK132161 Optetrak Logic PS 17MM & 19MM Thick Inserts, Optetrak Logic PSC 17MM…Exactech, Inc. · 2013
  10. Descendant · cites it directly · 2 of its ownK152170 Exactech Optetrak Logic Enhanced AssemblyExactech, Inc. · 2015 · Recalled
  11. Descendant · 2 generations on · 1 of its ownK171045 Exactech® Truliant™ Line ExtensionsExactech, Inc. · 2017 · Recalled
  12. Descendant · 2 generations on · 0 of its ownK223252 TRULIANT® E-PX Tibial Inserts; TRULIANT® E-PX PatellasExactech, Inc. · 2023 · Recalled

Most influential descendants

Showing 3 of 3 · See all
  • K152170Exactech Optetrak Logic Enhanced AssemblyExactech, Inc. · 2015 · cites it directly2descendants
  • K171045Exactech® Truliant™ Line ExtensionsExactech, Inc. · 2017 · 2 generations on1descendant
  • K223252TRULIANT® E-PX Tibial Inserts; TRULIANT® E-PX PatellasExactech, Inc. · 2023 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−8K936079Ecactech Porous Coated Finned Tibial Tray CompnentExactech, Inc.1994—
−7K011976Optetrak Total Knee System Size 0/1 Delta (Line Extension)Exactech, Inc.2001—
−6K032606Optetrak Total Knee System Asymmetric Femoral Components Size 6…Exactech, Inc.2003—
−5K033883Optetrak Total Knee System, HI-Flex Asymmetric Posterior-Stabilized Cemented…Exactech, Inc.20043
−4K093360Optetrak Logic Total Knee System Trapezoidal Tibial Tray, Sizes…Exactech, Inc.20102
−3K111400Optetrak Logic CR Tibial Insert, Optetrak Logic CR Femoral ComponentExactech, Inc.20111
−2K121307Optetrak Logic CR Tibial Insert, Size 0 Optetrak Logic CR Tibial Insert, Size…Exactech, Inc.2012—
−1K123342Optetrak Logic CRC Tibial InsertExactech, Inc.2013—
0 (this device)K132161Optetrak Logic PS 17MM & 19MM Thick Inserts, Optetrak Logic PSC 17MM & 19MM…Exactech, Inc.2013—
+1K152170Exactech Optetrak Logic Enhanced AssemblyExactech, Inc.20153
+2K171045Exactech® Truliant™ Line ExtensionsExactech, Inc.20172
+2K223252TRULIANT® E-PX Tibial Inserts; TRULIANT® E-PX PatellasExactech, Inc.20231

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199420
199530
199610
200110
200810
201110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201510
201710
202310
FIG. 1 — Lineage of K132161, 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? (7)

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
*K093360Optetrak Logic Total Knee System Trapezoidal Tibial Tray, Sizes 2.5F/1.5T-3.5F/4.5T
Summary page 1
…, Product Code i WH) Information on devices to which substantial equivalence is claimed: 510(k) Number Trade or proprietary or Model Name Manufacturer K093360 Optetrak Logic PS Exactech. Inc. KI 10547 Optetrak Logic PSC…
Exactech, Inc.20102
*K110547Optertrak Logic PSC Tibial Insert
Summary page 2
…7mm & 19mm Thick Inserts are modifications to Optetrak Logic ultra high molecular weight polyethylene (UI-MWPE) tibia[ insert components cleared per 5 10(k)s K093360. Kl 110547. K 111400. Kl12l307, and K 123342. This submission proposes adding I17mm and 19mm tibial insert options to the existing 9mm-lI m…
Exactech Sarasota2011—
*K111400Optetrak Logic CR Tibial Insert, Optetrak Logic CR Femoral Component
Summary page 2
…mm Thick Inserts are modifications to Optetrak Logic ultra high molecular weight polyethylene (UI-MWPE) tibia[ insert components cleared per 5 10(k)s K093360. Kl 110547. K 111400. Kl12l307, and K 123342. This submission proposes adding I17mm and 19mm tibial insert options to the existing 9mm-lI mrn range o…
Exactech, Inc.20111
*K121307Optetrak Logic CR Tibial Insert, Size 0 Optetrak Logic CR Tibial Insert, Size 6 Optetrak…
Summary page 1
…h. Inc. KI 10547 Optetrak Logic PSC Exactech. Inc. KI 11400 Optetrak Logic CR Exactech. Inc. K121307 Optetrak Logic CR Sizes 0 & 6 Exactech, Inc. K 123342 Optetrak Logic CRC…
Exactech, Inc.2012—
*K123342Optetrak Logic CRC Tibial Insert
Summary page 1
…h. Inc. KI 11400 Optetrak Logic CR Exactech. Inc. K121307 Optetrak Logic CR Sizes 0 & 6 Exactech, Inc. K 123342 Optetrak Logic CRC Exactech. Inc K933610 Exactech Cemented Total Knee System…
Exactech, Inc.2013—
*K933610Exactech Cemented Total Knee System, Tibial Components
Summary page 1
…ch. Inc. K121307 Optetrak Logic CR Sizes 0 & 6 Exactech, Inc. K 123342 Optetrak Logic CRC Exactech. Inc K933610 Exactech Cemented Total Knee System Exactech. Inc Tibial Components K932776…
Exactech, Inc.19957
*K932776Cruciate Retaining Cemented Tibial Components
Summary page 1
…Logic CRC Exactech. Inc K933610 Exactech Cemented Total Knee System Exactech. Inc Tibial Components K932776 Optetrak Cruciate Retaining Tibial Exactech. Inc Components Indications for Use: The…
Exactech, Inc.19942

Also cleared against K093360: 6 other devices →

What descends from it? (3)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K152170Exactech Optetrak Logic Enhanced AssemblyExactech, Inc.20152

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

Recalls of this device

DateClassRecallRoot causeReason
Aug 30, 2021Class IIZ-0021-2022Process controlInserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 19 years and passes through 1 company; a new generation was cleared every 1.5 years on median.
  • 9 of the 17 ancestors have a recall of any class.
  • Of its descendants, K152170 (Exactech, Inc., 2015) has gone furthest, with 2 descendants of its own.
  • 6 other devices also cite its predicate K093360.

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. 2013, this device’s year, is highlighted.

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

In the USA, the OPTETRAK Comprehensive Knee System is indicated for cemented use only.

Indications for use as stated in the FDA summary.

Also cleared against K093360

6 other devices cite the same predicate.

  • K153776Optetrak One Logic Femoral ComponentsExactech, Inc. · 2016
  • K152170Exactech Optetrak Logic Enhanced AssemblyExactech, Inc. · 20153 recalls
  • K150890Exactech Optetrak Logic CCExactech, Inc. · 20154 recalls
  • K123687Optetrak Logic Porous Femoral ComponentExactech, Inc. · 2013
  • K111400Optetrak Logic CR Tibial Insert, Optetrak Logic CR Femoral ComponentExactech, Inc. · 20111 recall
  • K110547Optertrak Logic PSC Tibial InsertExactech Sarasota · 2011

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/K132161 · printed Nov 6, 2026

Cite this page

510(k) Report. “K132161: Optetrak Logic PS 17MM & 19MM Thick Inserts, Optetrak Logic PSC 17MM & 19MM Thick Inserts.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132161

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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