510(k) · Cleared
ClearedTruliant 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 Sep 28, 2018 as substantially equivalent to K140302 (Exactech, Inc., 2014) after an 85-day review. Its family tree reaches back 9 generations to 1994.
- Decided
- Sep 28, 2018
- Review
- 85 days
- Class
- Class II
- Product code
- MBH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K936079 (1994). 22 ancestors in all, the oldest K933787 (1994). No later device cites it as a predicate yet.
- 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 backK123687 Optetrak Logic Porous Femoral ComponentExactech, Inc. · 2013
- 1 generation backK140302 Optetrak Logic Porous Femoral ComponentsExactech, Inc. · 2014
- This deviceK181794 Truliant Porous Femoral ComponentsExactech, Inc. · 2018
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 backK123687 Optetrak Logic Porous Femoral ComponentExactech, Inc. · 2013
- 1 generation backK140302 Optetrak Logic Porous Femoral ComponentsExactech, Inc. · 2014
- This deviceK181794 Truliant Porous Femoral ComponentsExactech, Inc. · 2018
View 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 | K123687 | Optetrak Logic Porous Femoral Component | Exactech, Inc. | 2013 | — |
| −1 | K140302 | Optetrak Logic Porous Femoral Components | Exactech, Inc. | 2014 | — |
| 0 (this device) | 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 |
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? (1)
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 |
|---|---|---|---|
| * | K140302 | Optetrak Logic Porous Femoral ComponentsSummary page 4…0 Device Class II Information on devices to which substantial equivalence is claimed: 510(k) Number Trade or Proprietary Model Name Manufacturer K140302 Optetrak Logic Porous Femoral Components Exactech, Inc… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
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 24 years and passes through 1 company; a new generation was cleared every 1.5 years on median.
- 11 of the 22 ancestors have a recall of any class.
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. 2018, 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 TRULIANT Femoral Components, Tibial Inserts, and Tibial Trays 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.
The TRULIANT Cemented Femoral Components, Tibial Inserts, and Tibial Trays are indicated for cemented use only. The TRULIANT Porous Femoral Components are indicated for cemented or cementless use.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K181794 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181794: Truliant 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/K181794
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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