510(k) · Cleared
ClearedTRULIANT Porous Tibial Tray and Exactech Alteon Bone Screws
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 Nov 26, 2018 as substantially equivalent to K123486 (Stryker, 2013) and 3 other predicates after a 90-day review. Its family tree reaches back 7 generations to 1998. 5 later devices descend from it.
- Decided
- Nov 26, 2018
- Review
- 90 days
- Class
- Class II
- Product code
- MBH
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 7 generations to K982302 (1998). 37 ancestors in all, the oldest K921114 (1993). 5 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK982302 Implex Continuum Knee - Hedrocel Tibial SpacersImplex Corp. · 1998
- 6 generations backK024161 Nexgen Complete Knee Solution - Trabecular Metal AugmentsImplex Corp. · 2003 · Recalled
- 5 generations backK040487 Trabecular Metal Knee System AugmentsImplex Corp. · 2004 · Recalled
- 4 generations backK053340 Trabecular Metal Tibial and Femoral Cone AugmentsZimmer Trabecular · 2006
- 3 generations backK100391 Depuy Universal Gription TF ConesDePuy Orthopaedics, Inc. · 2010
- 2 generations backK143393 Triathlon Tritanium Cone AugmentsStryker Orthopaedics · 2015 · Recalled
- 1 generation backK153595 Optetrak Logic Metaphyseal ConesExactech, Inc. · 2016
- This deviceK182346 TRULIANT Porous Tibial Tray and Exactech Alteon Bone ScrewsExactech, Inc. · 2018
- Descendant · cites it directly · 3 of its ownK241597 Freedom® Total Knee System - Porous Tibial Base PlateMaxx Orthopedics, Inc. · 2025
- Descendant · 2 generations on · 1 of its ownK251717 Freedom® Total Knee System – Titanium Tibial Base PlateMaxx Orthopedics, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK252777 Freedom Metaphyseal Cone Implants (Metaphyseal Cones)Maxx Orthopedics, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK253314 Freedom Infinia™ Total Knee SystemMaxx Orthopedics, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK240393 Exactech® TRULIANT® Knee SystemExactech, Inc. · 2024
Most influential descendants
Showing 5 of 5 · See all- K241597Freedom® Total Knee System - Porous Tibial Base PlateMaxx Orthopedics, Inc. · 2025 · cites it directly3descendants
- K251717Freedom® Total Knee System – Titanium Tibial Base PlateMaxx Orthopedics, Inc. · 2025 · 2 generations on1descendant
- K252777Freedom Metaphyseal Cone Implants (Metaphyseal Cones)Maxx Orthopedics, Inc. · 2025 · 2 generations on0descendants
- K253314Freedom Infinia™ Total Knee SystemMaxx Orthopedics, Inc. · 2025 · 2 generations on0descendants
- K240393Exactech® TRULIANT® Knee SystemExactech, Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K982302 | Implex Continuum Knee - Hedrocel Tibial Spacers | Implex Corp. | 1998 | — |
| −6 | K024161 | Nexgen Complete Knee Solution - Trabecular Metal Augments | Implex Corp. | 2003 | 2 |
| −5 | K040487 | Trabecular Metal Knee System Augments | Implex Corp. | 2004 | 1 |
| −4 | K053340 | Trabecular Metal Tibial and Femoral Cone Augments | Zimmer Trabecular | 2006 | — |
| −3 | K100391 | Depuy Universal Gription TF Cones | DePuy Orthopaedics, Inc. | 2010 | — |
| −2 | K143393 | Triathlon Tritanium Cone Augments | Stryker Orthopaedics | 2015 | 1 |
| −1 | K153595 | Optetrak Logic Metaphyseal Cones | Exactech, Inc. | 2016 | — |
| 0 (this device) | K182346 | TRULIANT Porous Tibial Tray and Exactech Alteon Bone Screws | Exactech, Inc. | 2018 | — |
| +1 | K241597 | Freedom® Total Knee System - Porous Tibial Base Plate | Maxx Orthopedics, Inc. | 2025 | — |
| +2 | K251717 | Freedom® Total Knee System – Titanium Tibial Base Plate | Maxx Orthopedics, Inc. | 2025 | — |
| +2 | K252777 | Freedom Metaphyseal Cone Implants (Metaphyseal Cones) | Maxx Orthopedics, Inc. | 2025 | — |
| +2 | K253314 | Freedom Infinia™ Total Knee System | Maxx Orthopedics, Inc. | 2025 | — |
| +1 | K240393 | Exactech® TRULIANT® Knee System | Exactech, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 3 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 5 | 0 |
| 2004 | 4 | 0 |
| 2005 | 4 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 4 | 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 |
|---|---|---|---|
| * | K123486 | Triathlon Tritanium Tibial BaseplateSummary page 6…Trade or Proprietary or Manufacturer Predicate Model Name Type K123486 Triathlon Tritanium Tibial Howmedica Osteonics Primary Baseplates… | 2013 |
| * | K120990 | Nexgen LCCK Trabecular Metal (TM) Coupled Tibial Cones Provisionals to Nexgen LCCK…Summary page 6…teonics Primary Baseplates Corp (marketed by Stryker) K120990 NexGen® LCCK Trabecular Zimmer Trabecular Additional Metal Coupl… | 2012 |
| * | K153595 | Optetrak Logic Metaphyseal ConesSummary page 6…ecular Additional Metal Coupled Tibial Cones Metal Technology, Inc. K153595 Optetrak Logic Metaphyseal Exactech, Inc. Additional Cones K141… | 2016 |
| * | K141797 | Alteon 6.5MM Bone ScrewsSummary page 6…Inc. K153595 Optetrak Logic Metaphyseal Exactech, Inc. Additional Cones K141797 Alteon 6.5mm Bone Screws Exactech, Inc. Additional… | 2014 |
What descends from it? (5)
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 20 years and passes through 5 companies; a new generation was cleared every 2.7 years on median.
- 22 of the 37 ancestors have a recall of any class.
- Of its descendants, K241597 (Maxx Orthopedics, Inc., 2025) has gone furthest, with 3 descendants of its own.
- 8 other devices also cite its predicate K123486.
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. All TRULIANT Femoral Components, Tibial…
Read the full statement (216 words)
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.
All TRULIANT Femoral Components, Tibial Inserts, and Tibial Trays are indicated for cemented use only, except the TRULIANT Porous Tibial Trays, which are indicated for cemented or cementless use.
Exactech Alteon Bone Screws are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Exactech Alteon Bone Screws are also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion.
The Exactech Alteon Bone Screws are also 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.
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/K182346 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182346: TRULIANT Porous Tibial Tray and Exactech Alteon Bone Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182346
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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