# K132161: Optetrak Logic PS 17MM & 19MM Thick Inserts, Optetrak Logic PSC 17MM & 19MM Thick Inserts

- Pathway: 510(k) (Traditional)
- Applicant: Exactech, Inc.
- Decided: Oct 11, 2013 after 91 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: 8 generations back to K936079 (1994). 17 ancestors in all.
3 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)
- K093360: Optetrak Logic Total Knee System Trapezoidal Tibial Tray, Sizes 2.5F/1.5T-3.5F/4.5T, Exactech, Inc. (2010) Summary page 1.
- K110547: Optertrak Logic PSC Tibial Insert, Exactech Sarasota (2011) Summary page 2.
- K111400: Optetrak Logic CR Tibial Insert, Optetrak Logic CR Femoral Component, Exactech, Inc. (2011) Summary page 2.
- K121307: Optetrak Logic CR Tibial Insert, Size 0 Optetrak Logic CR Tibial Insert, Size 6 Optetrak Logic CR Femoral Component, Siz, Exactech, Inc. (2012) Summary page 1.
- K123342: Optetrak Logic CRC Tibial Insert, Exactech, Inc. (2013) Summary page 1.
- K933610: Exactech Cemented Total Knee System, Tibial Components, Exactech, Inc. (1995) Summary page 1.
- K932776: Cruciate Retaining Cemented Tibial Components, Exactech, Inc. (1994) Summary page 1.

## Most influential descendants
- K152170: Exactech Optetrak Logic Enhanced Assembly (2015), 2 descendants of its own
- 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

## Recalls of this device
- Aug 30, 2021 · Class II · Z-0021-2022: Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.

## Indications for use
The OPTETRAK Comprehensive Knee Systems 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. In the USA, the OPTETRAK Comprehensive Knee System is indicated for cemented use only.

Source page: https://510kreport.com/device/K132161
Methodology: https://510kreport.com/methodology