510(k) · Cleared
Recalled · Class II · 2023Exactech Optetrak Logic Enhanced Assembly
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Exactech, Inc. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Sep 3, 2015 as substantially equivalent to K093360 (Exactech, Inc., 2010) and 7 other predicates after a 30-day review. Its family tree reaches back 9 generations to 1994. 2 later devices descend from it. It has been recalled 3 times.
- Decided
- Sep 3, 2015
- Review
- 30 days
- Class
- Class II
- Product code
- JWH
- Recalls
- 3
- Predicates
- 8
Its longest line of descent runs back 9 generations to K936079 (1994). 21 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK936079 Ecactech Porous Coated Finned Tibial Tray CompnentExactech, Inc. · 1994
- 5 generations between
- 3 generations backK121307 Optetrak Logic CR Tibial Insert, Size 0 Optetrak Logic CR Tibial…Exactech, Inc. · 2012
- 2 generations backK123342 Optetrak Logic CRC Tibial InsertExactech, Inc. · 2013
- 1 generation backK132161 Optetrak Logic PS 17MM & 19MM Thick Inserts, Optetrak Logic PSC 17MM…Exactech, Inc. · 2013 · Recalled
- This deviceK152170 Exactech Optetrak Logic Enhanced AssemblyExactech, Inc. · 2015
- Descendant · cites it directly · 1 of its ownK171045 Exactech® Truliant™ Line ExtensionsExactech, Inc. · 2017 · Recalled
- Descendant · cites it directly · 0 of its ownK223252 TRULIANT® E-PX Tibial Inserts; TRULIANT® E-PX PatellasExactech, Inc. · 2023 · Recalled
Show all 9 generations
- Root · 9 generations backK936079 Ecactech Porous Coated Finned Tibial Tray CompnentExactech, Inc. · 1994
- 8 generations backK011976 Optetrak Total Knee System Size 0/1 Delta (Line Extension)Exactech, Inc. · 2001
- 7 generations backK032606 Optetrak Total Knee System Asymmetric Femoral Components Size 6…Exactech, Inc. · 2003
- 6 generations backK033883 Optetrak Total Knee System, HI-Flex Asymmetric Posterior-Stabilized…Exactech, Inc. · 2004 · Recalled
- 5 generations backK093360 Optetrak Logic Total Knee System Trapezoidal Tibial Tray, Sizes…Exactech, Inc. · 2010 · Recalled
- 4 generations backK111400 Optetrak Logic CR Tibial Insert, Optetrak Logic CR Femoral ComponentExactech, Inc. · 2011 · Recalled
- 3 generations backK121307 Optetrak Logic CR Tibial Insert, Size 0 Optetrak Logic CR Tibial…Exactech, Inc. · 2012
- 2 generations backK123342 Optetrak Logic CRC Tibial InsertExactech, Inc. · 2013
- 1 generation backK132161 Optetrak Logic PS 17MM & 19MM Thick Inserts, Optetrak Logic PSC 17MM…Exactech, Inc. · 2013 · Recalled
- This deviceK152170 Exactech Optetrak Logic Enhanced AssemblyExactech, Inc. · 2015
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K936079 | Ecactech Porous Coated Finned Tibial Tray Compnent | Exactech, Inc. | 1994 | — |
| −8 | K011976 | Optetrak Total Knee System Size 0/1 Delta (Line Extension) | Exactech, Inc. | 2001 | — |
| −7 | K032606 | Optetrak Total Knee System Asymmetric Femoral Components Size 6… | Exactech, Inc. | 2003 | — |
| −6 | K033883 | Optetrak Total Knee System, HI-Flex Asymmetric Posterior-Stabilized Cemented… | Exactech, Inc. | 2004 | 3 |
| −5 | K093360 | Optetrak Logic Total Knee System Trapezoidal Tibial Tray, Sizes… | Exactech, Inc. | 2010 | 2 |
| −4 | K111400 | Optetrak Logic CR Tibial Insert, Optetrak Logic CR Femoral Component | Exactech, Inc. | 2011 | 1 |
| −3 | K121307 | Optetrak Logic CR Tibial Insert, Size 0 Optetrak Logic CR Tibial Insert, Size… | Exactech, Inc. | 2012 | — |
| −2 | K123342 | Optetrak Logic CRC Tibial Insert | Exactech, Inc. | 2013 | — |
| −1 | K132161 | Optetrak Logic PS 17MM & 19MM Thick Inserts, Optetrak Logic PSC 17MM & 19MM… | Exactech, Inc. | 2013 | 1 |
| 0 (this device) | K152170 | Exactech Optetrak Logic Enhanced Assembly | Exactech, Inc. | 2015 | — |
| +1 | K171045 | Exactech® Truliant™ Line Extensions | Exactech, Inc. | 2017 | 2 |
| +1 | K223252 | TRULIANT® E-PX Tibial Inserts; TRULIANT® E-PX Patellas | Exactech, Inc. | 2023 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 1 | 0 |
| 2001 | 2 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2023 | 1 | 0 |
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 K221479 Persona Personalized Knee Systemscore 22.4 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (8)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K093360 | Optetrak Logic Total Knee System Trapezoidal Tibial Tray, Sizes 2.5F/1.5T-3.5F/4.5TSummary page 4…/Metal/Polymer Information on devices to which substantial equivalence is claimed: 510(k) Number Trade or Proprietary Model Name Manufacturer K093360 Optetrak Logic PS K111400 Optetrak Logic CR, Sizes 1-5 K121307 Optetrak Logic CR, Sizes 0 & 6 K110547 Opt… | 2010 |
| * | K111400 | Optetrak Logic CR Tibial Insert, Optetrak Logic CR Femoral ComponentSummary page 4…evices to which substantial equivalence is claimed: 510(k) Number Trade or Proprietary Model Name Manufacturer K093360 Optetrak Logic PS K111400 Optetrak Logic CR, Sizes 1-5 K121307 Optetrak Logic CR, Sizes 0 & 6 K110547 Optetrak Logic PSC… | 2011 |
| * | K121307 | Optetrak Logic CR Tibial Insert, Size 0 Optetrak Logic CR Tibial Insert, Size 6 Optetrak…Summary page 4…claimed: 510(k) Number Trade or Proprietary Model Name Manufacturer K093360 Optetrak Logic PS K111400 Optetrak Logic CR, Sizes 1-5 K121307 Optetrak Logic CR, Sizes 0 & 6 K110547 Optetrak Logic PSC… | 2012 |
| * | K110547 | Optertrak Logic PSC Tibial InsertSummary page 4…Model Name Manufacturer K093360 Optetrak Logic PS K111400 Optetrak Logic CR, Sizes 1-5 K121307 Optetrak Logic CR, Sizes 0 & 6 K110547 Optetrak Logic PSC Exactech, Inc K123342 Opte… | 2011 |
| * | K123342 | Optetrak Logic CRC Tibial InsertSummary page 4…s 1-5 K121307 Optetrak Logic CR, Sizes 0 & 6 K110547 Optetrak Logic PSC Exactech, Inc K123342 Optetrak Logic CRC K132161 Optetrak Logic 17mm & 19mm Tibial Inserts K150890 Optetrak Logic CC K101981 Op… | 2013 |
| * | K132161 | Optetrak Logic PS 17MM & 19MM Thick Inserts, Optetrak Logic PSC 17MM & 19MM Thick InsertsSummary page 4…c CR, Sizes 0 & 6 K110547 Optetrak Logic PSC Exactech, Inc K123342 Optetrak Logic CRC K132161 Optetrak Logic 17mm & 19mm Tibial Inserts K150890 Optetrak Logic CC K101981 Optetrak Logic Combo Trays Indicat… | 2013 |
| * | K150890 | Exactech Optetrak Logic CCSummary page 4…Exactech, Inc K123342 Optetrak Logic CRC K132161 Optetrak Logic 17mm & 19mm Tibial Inserts K150890 Optetrak Logic CC K101981 Optetrak Logic Combo Trays Indications for Use: The OPTETRAK Comprehensive Knee Systems ar… | 2015 |
| * | K101981 | Optetrak Logic Combination Tibial TraySummary page 4…Exactech, Inc K123342 Optetrak Logic CRC K132161 Optetrak Logic 17mm & 19mm Tibial Inserts K150890 Optetrak Logic CC K101981 Optetrak Logic Combo Trays Indications for Use: The OPTETRAK Comprehensive Knee Systems are indicated for use in skeletall… | 2010 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 21, 2023 | Class II | Z-0585-2024 | Packaging change control | Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag. |
| Aug 30, 2021 | Class II | Z-0023-2022 | Process control | Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer. |
| Mar 13, 2019 | Class II | Z-1208-2019 | Under Investigation by firm | 2.5 Truliant Fit Trays were mismarked as 3 |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 1 company; a new generation was cleared every 1.5 years on median.
- 11 of the 21 ancestors have a recall of any class.
- Of its descendants, K171045 (Exactech, Inc., 2017) has gone furthest, with 1 descendant of its own.
- 6 other devices also cite its predicate K093360.
How does its category compare?
All JWH devicesJWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · JWH
20in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JWH
55in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JWH
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JWH
9,306in 2025
MAUDE reports naming product code JWH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 18 | 74 | 14 | 1,305 |
| 2008 | 17 | 81 | 10 | 1,483 |
| 2009 | 11 | 168 | 109 | 1,870 |
| 2010 | 19 | 85 | 32 | 3,286 |
| 2011 | 25 | 87 | 27 | 5,133 |
| 2012 | 33 | 85 | 85 | 5,203 |
| 2013 | 31 | 128 | 31 | 6,135 |
| 2014 | 33 | 98 | 13 | 6,722 |
| 2015 | 27 | 87 | 11 | 6,881 |
| 2016 | 18 | 88 | 17 | 7,586 |
| 2017 | 25 | 118 | 61 | 12,263 |
| 2018 | 25 | 90 | 14 | 14,071 |
| 2019 | 28 | 133 | 5 | 14,987 |
| 2020 | 22 | 59 | 2 | 12,592 |
| 2021 | 24 | 61 | 8 | 9,408 |
| 2022 | 17 | 56 | 12 | 8,364 |
| 2023 | 20 | 57 | 67 | 8,947 |
| 2024 | 19 | 89 | 7 | 10,828 |
| 2025 | 20 | 55 | 2 | 9,306 |
| 2026 | 12 | 63 | 4 | — |
What is it indicated for?
Optetrak Logic Total Knee System: 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…
Read the full statement (159 words)
Optetrak Logic Total Knee System:
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 Systems are indicated for cemented use only, except for the OPTETRAK Logic PS and CR Porous Femoral Components, which are indicated for cemented or cementless use.
Optetrak Logic CC Total Knee System:
The OPTETRAK Logic CC Total Knee System is 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 Logic CC Total Knee System is indicated for cemented use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152170 · printed Nov 3, 2026
Cite this page
510(k) Report. “K152170: Exactech Optetrak Logic Enhanced Assembly.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K152170
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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