# K170240: Truliant Femoral Components

- Pathway: 510(k) (Special)
- Applicant: Exactech, Inc.
- Decided: Feb 23, 2017 after 28 days
- Product code: JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K936079 (1994). 18 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153776: Optetrak One Logic Femoral Components, Exactech, Inc. (2016) Summary page 4.

## Most influential descendants
- K171045: Exactech® Truliant™ Line Extensions (2017), 1 descendant of its own
- K223252: TRULIANT® E-PX Tibial Inserts; TRULIANT® E-PX Patellas (2023), 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. The TRULIANT Femoral Components, Tibial Inserts, and Tibial Trays are indicated for cemented use only.

Source page: https://510kreport.com/device/K170240
Methodology: https://510kreport.com/methodology