# K182346: TRULIANT Porous Tibial Tray and Exactech Alteon Bone Screws

- Pathway: 510(k) (Traditional)
- Applicant: Exactech, Inc.
- Decided: Nov 26, 2018 after 90 days
- Product code: MBH (Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3565
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K982302 (1998). 37 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123486: Triathlon Tritanium Tibial Baseplate, Stryker (2013) Summary page 6.
- K120990: Nexgen LCCK Trabecular Metal (TM) Coupled Tibial Cones Provisionals to Nexgen LCCK Trabecular Metal (TM) Coupled Tibial, Zimmer Trabecular Metal Technology (2012) Summary page 6.
- K153595: Optetrak Logic Metaphyseal Cones, Exactech, Inc. (2016) Summary page 6.
- K141797: Alteon 6.5MM Bone Screws, Exactech, Inc. (2014) Summary page 6.

## Most influential descendants
- K241597: Freedom® Total Knee System - Porous Tibial Base Plate (2025), 3 descendants of its own
- K251717: Freedom® Total Knee System – Titanium Tibial Base Plate (2025), 1 descendant of its own
- K252777: Freedom Metaphyseal Cone Implants (Metaphyseal Cones) (2025), 0 descendants of its own
- K253314: Freedom Infinia™ Total Knee System (2025), 0 descendants of its own
- K240393: Exactech® TRULIANT® Knee System (2024), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K182346
Methodology: https://510kreport.com/methodology