510(k) · Cleared
Recalled · Class II · 2023Optetrak Logic CR Tibial Insert, Optetrak Logic CR Femoral Component
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 Jul 28, 2011 as substantially equivalent to K932690 (Exactech, Inc., 1995) and 2 other predicates after a 70-day review. Its family tree reaches back 5 generations to 1994. 12 later devices descend from it. It has been recalled once.
- Decided
- Jul 28, 2011
- Review
- 70 days
- Class
- Class II
- Product code
- JWH
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 5 generations to K936079 (1994). 13 ancestors in all. 12 later devices descend from it, 6 citing it directly.
- Root · 5 generations backK936079 Ecactech Porous Coated Finned Tibial Tray CompnentExactech, Inc. · 1994
- 4 generations backK011976 Optetrak Total Knee System Size 0/1 Delta (Line Extension)Exactech, Inc. · 2001
- 3 generations backK032606 Optetrak Total Knee System Asymmetric Femoral Components Size 6…Exactech, Inc. · 2003
- 2 generations backK033883 Optetrak Total Knee System, HI-Flex Asymmetric Posterior-Stabilized…Exactech, Inc. · 2004 · Recalled
- 1 generation backK093360 Optetrak Logic Total Knee System Trapezoidal Tibial Tray, Sizes…Exactech, Inc. · 2010 · Recalled
- This deviceK111400 Optetrak Logic CR Tibial Insert, Optetrak Logic CR Femoral ComponentExactech, Inc. · 2011
- Descendant · cites it directly · 11 of its ownK121307 Optetrak Logic CR Tibial Insert, Size 0 Optetrak Logic CR Tibial…Exactech, Inc. · 2012
- Descendant · cites it directly · 7 of its ownK123687 Optetrak Logic Porous Femoral ComponentExactech, Inc. · 2013
- Descendant · cites it directly · 4 of its ownK153776 Optetrak One Logic Femoral ComponentsExactech, Inc. · 2016
- Descendant · cites it directly · 4 of its ownK123342 Optetrak Logic CRC Tibial InsertExactech, Inc. · 2013
- Descendant · cites it directly · 3 of its ownK132161 Optetrak Logic PS 17MM & 19MM Thick Inserts, Optetrak Logic PSC 17MM…Exactech, Inc. · 2013 · Recalled
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K121307Optetrak Logic CR Tibial Insert, Size 0 Optetrak Logic CR Tibial Insert, Size 6 Optetrak…Exactech, Inc. · 2012 · cites it directly11descendants
- K123687Optetrak Logic Porous Femoral ComponentExactech, Inc. · 2013 · cites it directly7descendants
- K153776Optetrak One Logic Femoral ComponentsExactech, Inc. · 2016 · cites it directly4descendants
- K123342Optetrak Logic CRC Tibial InsertExactech, Inc. · 2013 · cites it directly4descendants
- K132161Optetrak Logic PS 17MM & 19MM Thick Inserts, Optetrak Logic PSC 17MM & 19MM Thick InsertsExactech, Inc. · 2013 · cites it directly3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K936079 | Ecactech Porous Coated Finned Tibial Tray Compnent | Exactech, Inc. | 1994 | — |
| −4 | K011976 | Optetrak Total Knee System Size 0/1 Delta (Line Extension) | Exactech, Inc. | 2001 | — |
| −3 | K032606 | Optetrak Total Knee System Asymmetric Femoral Components Size 6… | Exactech, Inc. | 2003 | — |
| −2 | K033883 | Optetrak Total Knee System, HI-Flex Asymmetric Posterior-Stabilized Cemented… | Exactech, Inc. | 2004 | 3 |
| −1 | K093360 | Optetrak Logic Total Knee System Trapezoidal Tibial Tray, Sizes… | Exactech, Inc. | 2010 | 2 |
| 0 (this device) | K111400 | Optetrak Logic CR Tibial Insert, Optetrak Logic CR Femoral Component | Exactech, Inc. | 2011 | — |
| +1 | K121307 | Optetrak Logic CR Tibial Insert, Size 0 Optetrak Logic CR Tibial Insert, Size… | Exactech, Inc. | 2012 | — |
| +1 | K123687 | Optetrak Logic Porous Femoral Component | Exactech, Inc. | 2013 | — |
| +1 | K153776 | Optetrak One Logic Femoral Components | Exactech, Inc. | 2016 | — |
| +1 | 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 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 1 | 0 |
| 2001 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 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? (3)
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 |
|---|---|---|---|
| * | K932690 | Exactech Cruciate Retaining Cemented Total Knee SYSummary page 1…tion: Class 11 Information on devices to which substantial equivalence is claimed: 5 10(k) Number Trade or Proprietary or Model Name Manufacturer K932690 Optetrak Cruciate Retaining Cemented Total Knee Exactech, Inc. System K093360 Optetrak… | 1995 |
| * | K093360 | Optetrak Logic Total Knee System Trapezoidal Tibial Tray, Sizes 2.5F/1.5T-3.5F/4.5TSummary page 1…Proprietary or Model Name Manufacturer K932690 Optetrak Cruciate Retaining Cemented Total Knee Exactech, Inc. System K093360 Optetrak Logic Total Knee System Exactech, Inc K082022 Optetrak CR Slope… | 2010 |
| * | K082022 | Optetrak 9MM Cruciate Retaining Tibial Insert, Slope ++Summary page 1…Cruciate Retaining Cemented Total Knee Exactech, Inc. System K093360 Optetrak Logic Total Knee System Exactech, Inc K082022 Optetrak CR Slope Exactech, Inc.… | 2008 |
What descends from it? (12)
See all 126 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K121307 | Optetrak Logic CR Tibial Insert, Size 0 Optetrak Logic CR Tibial Insert, Size 6 Optetrak… | 2012 | 11 |
| K123687 | Optetrak Logic Porous Femoral Component | 2013 | 7 |
| K153776 | Optetrak One Logic Femoral Components | 2016 | 4 |
| K123342 | Optetrak Logic CRC Tibial Insert | 2013 | 4 |
| K132161 | Optetrak Logic PS 17MM & 19MM Thick Inserts, Optetrak Logic PSC 17MM & 19MM Thick Inserts | 2013 | 3 |
| K152170 | Exactech Optetrak Logic Enhanced Assembly | 2015 | 2 |
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-0583-2024 | Packaging change control | Exactech 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 17 years and passes through 1 company; a new generation was cleared every 2.2 years on median.
- 8 of the 13 ancestors have a recall of any class.
- Of its descendants, K121307 (Exactech, Inc., 2012) has gone furthest, with 11 descendants of its own.
- 5 other devices also cite its predicate K932690.
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. 2011, 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?
The OPTETRAK Logic 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.
In the USA, the OPTETRAK Logic Total Knee System is indicated for cemented use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111400 · printed Nov 4, 2026
Cite this page
510(k) Report. “K111400: Optetrak Logic CR Tibial Insert, Optetrak Logic CR Femoral Component.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K111400
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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