510(k) Report

510(k) · Cleared

Recalled · Class II · 2013

Exactech Optetrak Proximal Tibial Spacer

K071738510(k) TraditionalCleared Aug 15, 200750-day reviewClass II21 CFR 888.3560Recalls 2

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 Aug 15, 2007 as substantially equivalent to K932776 (Exactech, Inc., 1994) and 6 other predicates after a 50-day review. Its family tree reaches back 4 generations to 1994. It has been recalled 2 times.

Decided
Aug 15, 2007
Review
50 days
Class
Class II
Product code
JWH
Recalls
2
Predicates
7

Its longest line of descent runs back 4 generations to K936079 (1994). 12 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2002: 1 other ancestor1996: 1 other ancestor1995: 3 other ancestors1994: 2 other ancestors2001: 1 other ancestorK936079 · 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 · recalled1990199520002005
Other ancestors, by generation 1 generation back: 4 other ancestors2 generations back: 4 other ancestors K033883 · 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. · 19940
  1. Root · 4 generations backK936079 Ecactech Porous Coated Finned Tibial Tray CompnentExactech, Inc. · 1994
  2. 3 generations backK011976 Optetrak Total Knee System Size 0/1 Delta (Line Extension)Exactech, Inc. · 2001
  3. 2 generations backK032606 Optetrak Total Knee System Asymmetric Femoral Components Size 6…Exactech, Inc. · 2003
  4. 1 generation backK033883 Optetrak Total Knee System, HI-Flex Asymmetric Posterior-Stabilized…Exactech, Inc. · 2004 · Recalled
  5. This deviceK071738 Exactech Optetrak Proximal Tibial SpacerExactech, Inc. · 2007
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K936079Ecactech Porous Coated Finned Tibial Tray CompnentExactech, Inc.1994—
−3K011976Optetrak Total Knee System Size 0/1 Delta (Line Extension)Exactech, Inc.2001—
−2K032606Optetrak Total Knee System Asymmetric Femoral Components Size 6…Exactech, Inc.2003—
−1K033883Optetrak Total Knee System, HI-Flex Asymmetric Posterior-Stabilized Cemented…Exactech, Inc.20043
0 (this device)K071738Exactech Optetrak Proximal Tibial SpacerExactech, Inc.2007—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199420
199530
199610
200110
200210
FIG. 1 — Lineage of K071738, 1994–2007Source: 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
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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
*K932776Cruciate Retaining Cemented Tibial Components
Summary page 1
…Code Exactech Cruciate Retaining Cemented Tibial Components #K932776/JWH Exactech Optetrak®Total Knee System Tibial Component…
Exactech, Inc.19942
*K933610Exactech Cemented Total Knee System, Tibial Components
Summary page 1
…#K932776/JWH Exactech Optetrak®Total Knee System Tibial Component #K933610/JWH Exactech Porous Coated Finned Tibial Tray Component…
Exactech, Inc.19957
*K936079Ecactech Porous Coated Finned Tibial Tray Compnent
Summary page 1
…#K933610/JWH Exactech Porous Coated Finned Tibial Tray Component #K936079/JWH Exactech Optetrak® Constrained Condylar Knee for Cemented Use…
Exactech, Inc.1994—
*K954208Optetrak Constrained Condylar Knee for Cemented Use Only
Summary page 1
…#K936079/JWH Exactech Optetrak® Constrained Condylar Knee for Cemented Use #K954208/JWH Exactech Optetrak® Size 0 and 1 Delta Line Extension…
Exactech, Inc.19961
*K011976Optetrak Total Knee System Size 0/1 Delta (Line Extension)
Summary page 1
…#K954208/JWH Exactech Optetrak® Size 0 and 1 Delta Line Extension #K011976/JWH Exactech Optetrak® Total Knee System Offset Tibial Tray…
Exactech, Inc.2001—
*K023186Optetrak Total Knee System Offset Tibial Tray
Summary page 1
…#K011976/JWH Exactech Optetrak® Total Knee System Offset Tibial Tray #K023186/JWH Optetrak® Total Knee System HI-FLEX Posterior-Stabilized Tibial Insert…
Exactech, Inc.200234
*K033883Optetrak Total Knee System, HI-Flex Asymmetric Posterior-Stabilized Cemented Femoral…
Summary page 1
…#K023186/JWH Optetrak® Total Knee System HI-FLEX Posterior-Stabilized Tibial Insert #K0338831JWH Components __…
Exactech, Inc.20043

Also cleared against K932776: 5 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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

Recalls of this device

DateClassRecallRoot causeReason
Feb 1, 2013Class IIZ-0953-2013Device DesignA dimensional mismatch was identified which can potentially allow for interference between devices.
Oct 17, 2011Class IIZ-2234-2012Device DesignExactech, Inc. of Gainesville, FL recalled their Optetrak Proximal Tibial Spacer after the devices were determined to be dimensionally incompatible to mate as intended with the Logic Tibial Tray.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 13 years and passes through 1 company; a new generation was cleared every 3.5 years on median.
  • 8 of the 12 ancestors have a recall of any class.
  • 5 other devices also cite its predicate K932776.

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. 2007, 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. The OPTETRAK Comprehensive Knee Systems are contraindicated in…

Read the full statement (120 words)

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.

The OPTETRAK Comprehensive Knee Systems are contraindicated in patients with active

infection, patients without sufficient bone stock to allow appropriate insertion and fixation of the

prosthesis, patients without sufficient soft tissue integrity to provide adequate stability, patients

with either mental or neuromuscular disorders that do not allow control of the knee joint, and

patients whose weight, age, or activity level might cause extreme loads and early failure of the

system.

Indications for use as stated in the FDA summary.

Also cleared against K932776

5 other devices cite the same predicate.

  • K132161Optetrak Logic PS 17MM & 19MM Thick Inserts, Optetrak Logic PSC 17MM & 19MM Thick InsertsExactech, Inc. · 20131 recall
  • K100900Motivation Knee SystemEncore Medical L.P. · 20104 recalls
  • K093360Optetrak Logic Total Knee System Trapezoidal Tibial Tray, Sizes 2.5F/1.5T-3.5F/4.5TExactech, Inc. · 20102 recalls
  • K030686Optetrak Total Knee System - Molded Metal-Back Tibial ComponentExactech, Inc. · 2003
  • 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/K071738 · printed Nov 5, 2026

Cite this page

510(k) Report. “K071738: Exactech Optetrak Proximal Tibial Spacer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K071738

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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