# K223252: TRULIANT® E-PX Tibial Inserts; TRULIANT® E-PX Patellas

- Pathway: 510(k) (Traditional)
- Applicant: Exactech, Inc.
- Decided: Jul 17, 2023 after 269 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K936079 (1994). 75 ancestors in all.
No later device cites it as a predicate yet.
0 of 76 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152170: Exactech Optetrak Logic Enhanced Assembly, Exactech, Inc. (2015) Summary page 4.
- K171045: Exactech® Truliant™ Line Extensions, Exactech, Inc. (2017) Summary page 4.
- K932690: Exactech Cruciate Retaining Cemented Total Knee SY, Exactech, Inc. (1995) Summary page 4.
- K160484: Optetrak Advanced Patella, Exactech, Inc. (2016) Summary page 4.
- K150890: Exactech Optetrak Logic CC, Exactech, Inc. (2015) Summary page 4.
- K211877: Klassic Knee System, Total Joint Orthopedics, Inc. (2022) Summary page 4.

## Recalls of this device
- Nov 21, 2023 · Class II · Z-0586-2024: Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.

## Indications for use
The TRULIANT E-PX Tibial Inserts and Patellas 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 E-PX Patellas are intended for cemented use only.

Source page: https://510kreport.com/device/K223252
Methodology: https://510kreport.com/methodology