510(k) · Cleared
ClearedOptetrak Logic Porous 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 Jul 30, 2014 as substantially equivalent to K123687 (Exactech, Inc., 2013) and 1 other predicate after a 174-day review. Its family tree reaches back 8 generations to 1994. 1 later device descends from it.
- Decided
- Jul 30, 2014
- Review
- 174 days
- Class
- Class II
- Product code
- MBH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K936079 (1994). 21 ancestors in all, the oldest K933787 (1994). 1 later device descends from it, 1 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 deviceK140302 Optetrak Logic Porous Femoral ComponentsExactech, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK181794 Truliant Porous Femoral ComponentsExactech, Inc. · 2018
Most influential descendants
Showing 1 of 1 · See all- K181794Truliant Porous Femoral ComponentsExactech, Inc. · 2018 · 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) | K140302 | Optetrak Logic Porous Femoral Components | Exactech, Inc. | 2014 | — |
| +1 | K181794 | Truliant Porous Femoral Components | Exactech, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 5 | 0 |
| 1995 | 3 | 0 |
| 1996 | 2 | 0 |
| 2001 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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? (2)
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 |
|---|---|---|---|
| * | K123687 | Optetrak Logic Porous Femoral ComponentSummary page 1…WH, MBH Information on devices to which substantial equivalence is claimed: 5 10(k) Trade or Proprietary or Model Name Manufacturer K 123687 Optetrak Logic Porous Femoral Components Exactech, Inc K062654 Sigma CR Porocoat®D Femoral Compo… | 2013 |
| * | K062654 | Depuy Sigma Cruciate Retaining Porocoat Femoral ComponentsSummary page 1…de or Proprietary or Model Name Manufacturer K 123687 Optetrak Logic Porous Femoral Components Exactech, Inc K062654 Sigma CR Porocoat®D Femoral Components DePuy Indications for Use: The OPTETRLAK Comprehensive Kn… | 2006 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181794 | Truliant Porous Femoral Components | 2018 | 0 |
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 20 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, K181794 (Exactech, Inc., 2018) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K123687.
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. 2014, 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/K140302 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140302: Optetrak Logic Porous Femoral Components.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140302
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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