510(k) · Cleared
Recalled · Class II · 2023Exactech Optetrak Logic CC
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 May 29, 2015 as substantially equivalent to K954208 (Exactech, Inc., 1996) and 3 other predicates after a 57-day review. Its family tree reaches back 5 generations to 1994. 3 later devices descend from it. It has been recalled 4 times.
- Decided
- May 29, 2015
- Review
- 57 days
- Class
- Class II
- Product code
- JWH
- Recalls
- 4
- Predicates
- 4
Its longest line of descent runs back 5 generations to K936079 (1994). 13 ancestors in all. 3 later devices descend from it, 2 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 deviceK150890 Exactech Optetrak Logic CCExactech, Inc. · 2015
- Descendant · cites it directly · 2 of its ownK152170 Exactech Optetrak Logic Enhanced AssemblyExactech, Inc. · 2015 · Recalled
- Descendant · 2 generations on · 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
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 · cites it directly0descendants
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) | K150890 | Exactech Optetrak Logic CC | Exactech, Inc. | 2015 | — |
| +1 | K152170 | Exactech Optetrak Logic Enhanced Assembly | Exactech, Inc. | 2015 | 3 |
| +2 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 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? (4)
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 |
|---|---|---|---|
| * | K954208 | Optetrak Constrained Condylar Knee for Cemented Use OnlySummary page 4…/Metal/Polymer Information on devices to which substantial equivalence is claimed: 510(k) Number Trade or Proprietary Model Name Manufacturer K954208 Optetrak CC Exactech, Inc K093360 Optetrak Logic… | 1996 |
| * | K093360 | Optetrak Logic Total Knee System Trapezoidal Tibial Tray, Sizes 2.5F/1.5T-3.5F/4.5TSummary page 4…10(k) Number Trade or Proprietary Model Name Manufacturer K954208 Optetrak CC Exactech, Inc K093360 Optetrak Logic Exactech, Inc K933610 Optetrak Trapezoidal Trays… | 2010 |
| * | K933610 | Exactech Cemented Total Knee System, Tibial ComponentsSummary page 4…54208 Optetrak CC Exactech, Inc K093360 Optetrak Logic Exactech, Inc K933610 Optetrak Trapezoidal Trays Exactech, Inc. K012251 Optetrak Stem Extensions… | 1995 |
| * | K012251 | Optetrak Total Knee System, Straight Stem Extensions - Additional SizesSummary page 4…3360 Optetrak Logic Exactech, Inc K933610 Optetrak Trapezoidal Trays Exactech, Inc. K012251 Optetrak Stem Extensions Exactech, Inc Indications for Use: The Optetrak Logic CC Total K… | 2001 |
What descends from it? (3)
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-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. |
| Jan 27, 2020 | Class II | Z-1364-2020 | Labeling mix-ups | These Truliant Splined Stem Extension, 18mm x 120mm were found to have a labeling error. The upper right corner of the label incorrectly identifies the implant size as 17mm x 80mm when the implant size is 18mm x 120mm. |
| May 8, 2018 | Class II | Z-3209-2018 | Under Investigation by firm | Potentially have non-conforming internal threads. |
| Apr 7, 2017 | Class II | Z-2704-2017 | Process control | Missing Screw in carton. Nine (9) serial numbers were identified as being inadvertently packaged as one per carton when two per carton are required. |
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 5.4 years on median.
- 8 of the 13 ancestors have a recall of any class.
- Of its descendants, K152170 (Exactech, Inc., 2015) has gone furthest, with 2 descendants of its own.
- 4 other devices also cite its predicate K954208.
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?
The Exactech® Optetrak Logic® CC 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 Exactech® Optetrak Logic® CC is indicated for cemented use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150890 · printed Nov 5, 2026
Cite this page
510(k) Report. “K150890: Exactech Optetrak Logic CC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K150890
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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