510(k) · Cleared
ClearedOptetrak One Logic Femoral Components
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Exactech, Inc. · MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Cleared on Mar 10, 2016 as substantially equivalent to K093360 (Exactech, Inc., 2010) and 3 other predicates after a 70-day review. Its family tree reaches back 8 generations to 1994. 4 later devices descend from it.
- Decided
- Mar 10, 2016
- Review
- 70 days
- Class
- Class II
- Product code
- MBH
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 8 generations to K936079 (1994). 17 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK936079 Ecactech Porous Coated Finned Tibial Tray CompnentExactech, Inc. · 1994
- 7 generations backK011976 Optetrak Total Knee System Size 0/1 Delta (Line Extension)Exactech, Inc. · 2001
- 6 generations backK032606 Optetrak Total Knee System Asymmetric Femoral Components Size 6…Exactech, Inc. · 2003
- 5 generations backK033883 Optetrak Total Knee System, HI-Flex Asymmetric Posterior-Stabilized…Exactech, Inc. · 2004 · Recalled
- 4 generations backK093360 Optetrak Logic Total Knee System Trapezoidal Tibial Tray, Sizes…Exactech, Inc. · 2010 · Recalled
- 3 generations backK111400 Optetrak Logic CR Tibial Insert, Optetrak Logic CR Femoral ComponentExactech, Inc. · 2011 · Recalled
- 2 generations backK121307 Optetrak Logic CR Tibial Insert, Size 0 Optetrak Logic CR Tibial…Exactech, Inc. · 2012
- 1 generation backK123687 Optetrak Logic Porous Femoral ComponentExactech, Inc. · 2013
- This deviceK153776 Optetrak One Logic Femoral ComponentsExactech, Inc. · 2016
- Descendant · cites it directly · 2 of its ownK170240 Truliant Femoral ComponentsExactech, Inc. · 2017
- Descendant · 2 generations on · 1 of its ownK171045 Exactech® Truliant™ Line ExtensionsExactech, Inc. · 2017 · Recalled
- Descendant · 3 generations on · 0 of its ownK223252 TRULIANT® E-PX Tibial Inserts; TRULIANT® E-PX PatellasExactech, Inc. · 2023 · Recalled
- Descendant · cites it directly · 0 of its ownK162256 Klassic Femur, Porous, Klassic Tibial Baseplate, PorousTotal Joint Orthopedics, Inc. · 2016
Most influential descendants
Showing 4 of 4 · See all- K170240Truliant Femoral ComponentsExactech, Inc. · 2017 · cites it directly2descendants
- K171045Exactech® Truliant™ Line ExtensionsExactech, Inc. · 2017 · 2 generations on1descendant
- K223252TRULIANT® E-PX Tibial Inserts; TRULIANT® E-PX PatellasExactech, Inc. · 2023 · 3 generations on0descendants
- K162256Klassic Femur, Porous, Klassic Tibial Baseplate, PorousTotal Joint Orthopedics, Inc. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K936079 | Ecactech Porous Coated Finned Tibial Tray Compnent | Exactech, Inc. | 1994 | — |
| −7 | K011976 | Optetrak Total Knee System Size 0/1 Delta (Line Extension) | Exactech, Inc. | 2001 | — |
| −6 | K032606 | Optetrak Total Knee System Asymmetric Femoral Components Size 6… | Exactech, Inc. | 2003 | — |
| −5 | K033883 | Optetrak Total Knee System, HI-Flex Asymmetric Posterior-Stabilized Cemented… | Exactech, Inc. | 2004 | 3 |
| −4 | K093360 | Optetrak Logic Total Knee System Trapezoidal Tibial Tray, Sizes… | Exactech, Inc. | 2010 | 2 |
| −3 | K111400 | Optetrak Logic CR Tibial Insert, Optetrak Logic CR Femoral Component | Exactech, Inc. | 2011 | 1 |
| −2 | 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 | — |
| 0 (this device) | K153776 | Optetrak One Logic Femoral Components | Exactech, Inc. | 2016 | — |
| +1 | K170240 | Truliant Femoral Components | Exactech, Inc. | 2017 | — |
| +2 | K171045 | Exactech® Truliant™ Line Extensions | Exactech, Inc. | 2017 | 2 |
| +3 | K223252 | TRULIANT® E-PX Tibial Inserts; TRULIANT® E-PX Patellas | Exactech, Inc. | 2023 | 1 |
| +1 | K162256 | Klassic Femur, Porous, Klassic Tibial Baseplate, Porous | Total Joint Orthopedics, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 3 | 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 |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 2 | 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 MBH? 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 MBH device
- #1 K241597 Freedom® Total Knee System - Porous Tibial…score 19.9 · 8 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 |
|---|---|---|---|
| * | K093360 | Optetrak Logic Total Knee System Trapezoidal Tibial Tray, Sizes 2.5F/1.5T-3.5F/4.5TSummary page 4…Device Class II 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… | 2010 |
| * | K111400 | Optetrak Logic CR Tibial Insert, Optetrak Logic CR Femoral ComponentSummary page 4…n 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 Exactech, Inc K121307… | 2011 |
| * | K121307 | Optetrak Logic CR Tibial Insert, Size 0 Optetrak Logic CR Tibial Insert, Size 6 Optetrak…Summary page 4…anufacturer K093360 Optetrak Logic PS K111400 Optetrak Logic CR, Sizes 1-5 Exactech, Inc K121307 Optetrak Logic CR, Sizes 0 & 6 K123687 Optetrak Logic Porous Femoral Components… | 2012 |
| * | K123687 | Optetrak Logic Porous Femoral ComponentSummary page 4…111400 Optetrak Logic CR, Sizes 1-5 Exactech, Inc K121307 Optetrak Logic CR, Sizes 0 & 6 K123687 Optetrak Logic Porous Femoral Components… | 2013 |
What descends from it? (4)
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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 1 company; a new generation was cleared every 2.2 years on median.
- 9 of the 17 ancestors have a recall of any class.
- Of its descendants, K170240 (Exactech, Inc., 2017) has gone furthest, with 2 descendants of its own.
- 6 other devices also cite its predicate K093360.
How does its category compare?
All MBH devicesMBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · MBH
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MBH
98in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MBH
1in 2024
Class I (5 since 2007) Class II/III not classified
Adverse event reports per year · MBH
1,561in 2025
MAUDE reports naming product code MBH, 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 | 10 | 59 | 0 | 27 |
| 2008 | 3 | 70 | 0 | 21 |
| 2009 | 3 | 209 | 2 | 89 |
| 2010 | 4 | 84 | 0 | 121 |
| 2011 | 5 | 84 | 15 | 247 |
| 2012 | 5 | 90 | 1 (1) | 370 |
| 2013 | 6 | 138 | 4 (4) | 308 |
| 2014 | 9 | 114 | 0 | 385 |
| 2015 | 8 | 100 | 0 | 955 |
| 2016 | 4 | 74 | 1 | 1,034 |
| 2017 | 4 | 115 | 9 | 1,007 |
| 2018 | 6 | 89 | 1 | 1,191 |
| 2019 | 1 | — | 1 | 1,394 |
| 2020 | 7 | 112 | 2 | 1,089 |
| 2021 | 6 | 48 | 0 | 1,539 |
| 2022 | 7 | 57 | 0 | 1,261 |
| 2023 | 6 | 94 | 2 | 1,263 |
| 2024 | 10 | 84 | 1 | 1,497 |
| 2025 | 8 | 98 | 0 | 1,561 |
| 2026 | 7 | 153 | 4 | — |
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. 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153776 · printed Nov 5, 2026
Cite this page
510(k) Report. “K153776: Optetrak One Logic Femoral Components.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K153776
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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