# K152170: Exactech Optetrak Logic Enhanced Assembly

- Pathway: 510(k) (Special)
- Applicant: Exactech, Inc.
- Decided: Sep 3, 2015 after 30 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: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K936079 (1994). 21 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 24 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 4.
- K111400: Optetrak Logic CR Tibial Insert, Optetrak Logic CR Femoral Component, Exactech, Inc. (2011) Summary page 4.
- 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 4.
- K110547: Optertrak Logic PSC Tibial Insert, Exactech Sarasota (2011) Summary page 4.
- K123342: Optetrak Logic CRC Tibial Insert, Exactech, Inc. (2013) Summary page 4.
- K132161: Optetrak Logic PS 17MM & 19MM Thick Inserts, Optetrak Logic PSC 17MM & 19MM Thick Inserts, Exactech, Inc. (2013) Summary page 4.
- K150890: Exactech Optetrak Logic CC, Exactech, Inc. (2015) Summary page 4.
- K101981: Optetrak Logic Combination Tibial Tray, Exactech, Inc. (2010) 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

## 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.
- Mar 13, 2019 · Class II · Z-1208-2019: 2.5 Truliant Fit Trays were mismarked as 3

## Indications for use
Optetrak Logic Total Knee System: 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 Systems are indicated for cemented use only, except for the OPTETRAK Logic PS and CR Porous Femoral Components, which are indicated for cemented or cementless use. Optetrak Logic CC Total Knee System: The OPTETRAK Logic CC Total Knee System is 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 OPTETRAK Logic CC Total Knee System is indicated for cemented use only.

Source page: https://510kreport.com/device/K152170
Methodology: https://510kreport.com/methodology