# K171045: Exactech® Truliant™ Line Extensions

- Pathway: 510(k) (Special)
- Applicant: Exactech, Inc.
- Decided: Apr 28, 2017 after 21 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: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K936079 (1994). 26 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170240: Truliant Femoral Components, Exactech, Inc. (2017) Summary page 4.
- K152170: Exactech Optetrak Logic Enhanced Assembly, Exactech, Inc. (2015) Summary page 4.

## Most influential descendants
- K223252: TRULIANT® E-PX Tibial Inserts; TRULIANT® E-PX Patellas (2023), 0 descendants of its own

## Recalls of this device
- Nov 21, 2023 · Class II · Z-0585-2024: Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
- Aug 30, 2021 · Class II · Z-0023-2022: Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.

## 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/K171045
Methodology: https://510kreport.com/methodology