510(k) Report

510(k) · Cleared

Recalled · Class II · 2023

TRULIANT® E-PX Tibial Inserts; TRULIANT® E-PX Patellas

K223252510(k) TraditionalCleared Jul 17, 2023269-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 Jul 17, 2023 as substantially equivalent to K152170 (Exactech, Inc., 2015) and 5 other predicates after a 269-day review. Its family tree reaches back 11 generations to 1994. It has been recalled once.

Decided
Jul 17, 2023
Review
269 days
Class
Class II
Product code
JWH
Recalls
1
Predicates
6

Its longest line of descent runs back 11 generations to K936079 (1994). 75 ancestors in all, the oldest P830055 (1985). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2022: 1 other ancestor2016: 3 other ancestors2015: 4 other ancestors1995: 8 other ancestors2018: 1 other ancestor2017: 1 other ancestor2011: 1 other ancestor2010: 1 other ancestor2001: 3 other ancestors1996: 3 other ancestors2014: 1 other ancestor2012: 1 other ancestor2008: 1 other ancestor1994: 5 other ancestors2013: 1 other ancestor2009: 1 other ancestor2007: 2 other ancestors2006: 2 other ancestors2000: 3 other ancestors1993: 3 other ancestors1991: 3 other ancestors2005: 1 other ancestor2004: 2 other ancestors2003: 1 other ancestor2002: 1 other ancestor1997: 5 other ancestors1987: 2 other ancestors1985: 1 other ancestor1998: 1 other ancestor1990: 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. · 2001×2: 2 generations cleared close together, K032606 (2003), K033883 (2004) K093360 · 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. · 2013K132161 · Optetrak Logic PS 17MM & 19MM Thick Inserts, Optetrak Logic PSC 17MM & 19MM Thick Inserts · Exactech, Inc. · 2013 · recalledK152170 · Exactech Optetrak Logic Enhanced Assembly · Exactech, Inc. · 2015 · recalledK171045 · Exactech® Truliant™ Line Extensions · Exactech, Inc. · 2017 · recalled1990200020102020
Other ancestors, by generation 1 generation back: 4 other ancestors2 generations back: 7 other ancestors3 generations back: 10 other ancestors4 generations back: 13 other ancestors5 generations back: 19 other ancestors6 generations back: 4 other ancestors7 generations back: 7 other ancestors K171045 · Exactech® Truliant™ Line Extensions · Exactech, Inc. · 2017 · recalledK152170 · Exactech Optetrak Logic Enhanced Assembly · Exactech, Inc. · 2015 · recalledK132161 · Optetrak Logic PS 17MM & 19MM Thick Inserts, Optetrak Logic PSC 17MM & 19MM Thick Inserts · Exactech, Inc. · 2013 · recalledK123342 · 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. · 1994−10−50
  1. Root · 11 generations backK936079 Ecactech Porous Coated Finned Tibial Tray CompnentExactech, Inc. · 1994
  2. 7 generations between
  3. 3 generations backK132161 Optetrak Logic PS 17MM & 19MM Thick Inserts, Optetrak Logic PSC 17MM…Exactech, Inc. · 2013 · Recalled
  4. 2 generations backK152170 Exactech Optetrak Logic Enhanced AssemblyExactech, Inc. · 2015 · Recalled
  5. 1 generation backK171045 Exactech® Truliant™ Line ExtensionsExactech, Inc. · 2017 · Recalled
  6. This deviceK223252 TRULIANT® E-PX Tibial Inserts; TRULIANT® E-PX PatellasExactech, Inc. · 2023
Show all 11 generations
  1. Root · 11 generations backK936079 Ecactech Porous Coated Finned Tibial Tray CompnentExactech, Inc. · 1994
  2. 10 generations backK011976 Optetrak Total Knee System Size 0/1 Delta (Line Extension)Exactech, Inc. · 2001
  3. 9 generations backK032606 Optetrak Total Knee System Asymmetric Femoral Components Size 6…Exactech, Inc. · 2003
  4. 8 generations backK033883 Optetrak Total Knee System, HI-Flex Asymmetric Posterior-Stabilized…Exactech, Inc. · 2004 · Recalled
  5. 7 generations backK093360 Optetrak Logic Total Knee System Trapezoidal Tibial Tray, Sizes…Exactech, Inc. · 2010 · Recalled
  6. 6 generations backK111400 Optetrak Logic CR Tibial Insert, Optetrak Logic CR Femoral ComponentExactech, Inc. · 2011 · Recalled
  7. 5 generations backK121307 Optetrak Logic CR Tibial Insert, Size 0 Optetrak Logic CR Tibial…Exactech, Inc. · 2012
  8. 4 generations backK123342 Optetrak Logic CRC Tibial InsertExactech, Inc. · 2013
  9. 3 generations backK132161 Optetrak Logic PS 17MM & 19MM Thick Inserts, Optetrak Logic PSC 17MM…Exactech, Inc. · 2013 · Recalled
  10. 2 generations backK152170 Exactech Optetrak Logic Enhanced AssemblyExactech, Inc. · 2015 · Recalled
  11. 1 generation backK171045 Exactech® Truliant™ Line ExtensionsExactech, Inc. · 2017 · Recalled
  12. This deviceK223252 TRULIANT® E-PX Tibial Inserts; TRULIANT® E-PX PatellasExactech, Inc. · 2023
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−11K936079Ecactech Porous Coated Finned Tibial Tray CompnentExactech, Inc.1994—
−10K011976Optetrak Total Knee System Size 0/1 Delta (Line Extension)Exactech, Inc.2001—
−9K032606Optetrak Total Knee System Asymmetric Femoral Components Size 6…Exactech, Inc.2003—
−8K033883Optetrak Total Knee System, HI-Flex Asymmetric Posterior-Stabilized Cemented…Exactech, Inc.20043
−7K093360Optetrak Logic Total Knee System Trapezoidal Tibial Tray, Sizes…Exactech, Inc.20102
−6K111400Optetrak Logic CR Tibial Insert, Optetrak Logic CR Femoral ComponentExactech, Inc.20111
−5K121307Optetrak Logic CR Tibial Insert, Size 0 Optetrak Logic CR Tibial Insert, Size…Exactech, Inc.2012—
−4K123342Optetrak Logic CRC Tibial InsertExactech, Inc.2013—
−3K132161Optetrak Logic PS 17MM & 19MM Thick Inserts, Optetrak Logic PSC 17MM & 19MM…Exactech, Inc.20131
−2K152170Exactech Optetrak Logic Enhanced AssemblyExactech, Inc.20153
−1K171045Exactech® Truliant™ Line ExtensionsExactech, Inc.20172
0 (this device)K223252TRULIANT® E-PX Tibial Inserts; TRULIANT® E-PX PatellasExactech, Inc.2023—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198510
198720
199010
199130
199330
199450
199580
199630
199750
199810
200030
200130
200210
200310
200420
200510
200620
200720
200810
200910
201010
201110
201210
201310
201410
201540
201630
201710
201810
202210
FIG. 1 — Lineage of K223252, 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? (6)

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
*K152170Exactech Optetrak Logic Enhanced Assembly
Summary page 4
…s: Predicate Predicate Trade Name (Primary Predicate is listed Product Number first) Code K152170 Exactech Optetrak Logic Enhanced Assembly JWH K171045 Exactech Truliant Line Extensions…
Exactech, Inc.20153
*K171045Exactech® Truliant™ Line Extensions
Summary page 4
…oduct Number first) Code K152170 Exactech Optetrak Logic Enhanced Assembly JWH K171045 Exactech Truliant Line Extensions JWH K932690 Exactech Cruciate Retaining Cemented Total…
Exactech, Inc.20172
*K932690Exactech Cruciate Retaining Cemented Total Knee SY
Summary page 4
…Code K152170 Exactech Optetrak Logic Enhanced Assembly JWH K171045 Exactech Truliant Line Extensions JWH K932690 Exactech Cruciate Retaining Cemented Total Knee System JWH K160484 Optetrak Advanced Patella…
Exactech, Inc.19956
*K160484Optetrak Advanced Patella
Summary page 4
…JWH K171045 Exactech Truliant Line Extensions JWH K932690 Exactech Cruciate Retaining Cemented Total Knee System JWH K160484 Optetrak Advanced Patella JWH K150890 Exactech Optetrak Logic CC…
Exactech, Inc.20165
*K150890Exactech Optetrak Logic CC
Summary page 4
…JWH K932690 Exactech Cruciate Retaining Cemented Total Knee System JWH K160484 Optetrak Advanced Patella JWH K150890 Exactech Optetrak Logic CC JWH K211877 Klassic Knee System…
Exactech, Inc.20154
*K211877Klassic Knee System
Summary page 4
…JWH K160484 Optetrak Advanced Patella JWH K150890 Exactech Optetrak Logic CC JWH K211877 Klassic Knee System JWH Device Description Summary The TRULIANT Knee System is…
Total Joint Orthopedics, Inc.2022—

Also cleared against K152170: 1 other device →

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
Nov 21, 2023Class IIZ-0586-2024Packaging 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?

  • The line of descent spans 29 years and passes through 1 company; a new generation was cleared every 1.7 years on median.
  • 37 of the 75 ancestors have a recall of any class.
  • 1 other device also cites its predicate K152170.

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. 2023, 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 TRULIANT E-PX Tibial Inserts and Patellas 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 TRULIANT E-PX Patellas are intended for cemented use only.

Indications for use as stated in the FDA summary.

Also cleared against K152170

1 other device cites the same predicate.

  • K171045Exactech® Truliant™ Line ExtensionsExactech, Inc. · 20172 recalls

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/K223252 · printed Nov 6, 2026

Cite this page

510(k) Report. “K223252: TRULIANT® E-PX Tibial Inserts; TRULIANT® E-PX Patellas.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K223252

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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