# K123687: Optetrak Logic Porous Femoral Component

- Pathway: 510(k) (Traditional)
- Applicant: Exactech, Inc.
- Decided: Mar 20, 2013 after 107 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: 7 generations back to K936079 (1994). 16 ancestors in all.
7 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 1.
- K111400: Optetrak Logic CR Tibial Insert, Optetrak Logic CR Femoral Component, Exactech, Inc. (2011) Summary page 1.
- 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.
- K935726: Exactech Porous Coated Cruciate Retained Femoral Component, Exactech, Inc. (1994) Summary page 1.
- K935773: Exactech Porous Coated Posterior Stabilized Femoral Component, Exactech, Inc. (1994) Summary page 1.

## Most influential descendants
- K153776: Optetrak One Logic Femoral Components (2016), 4 descendants of its own
- K170240: Truliant Femoral Components (2017), 2 descendants of its own
- K171045: Exactech® Truliant™ Line Extensions (2017), 1 descendant of its own
- K140302: Optetrak Logic Porous Femoral Components (2014), 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 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/K123687
Methodology: https://510kreport.com/methodology