# K153776: Optetrak One Logic Femoral Components

- Pathway: 510(k) (Special)
- Applicant: Exactech, Inc.
- Decided: Mar 10, 2016 after 70 days
- Product code: MBH (Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3565
- Recalls of this device: none
- 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.
4 later devices descend from it; 2 cite it directly.
0 of 22 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.
- K123687: Optetrak Logic Porous Femoral Component, Exactech, Inc. (2013) Summary page 4.

## Most influential descendants
- K170240: Truliant Femoral Components (2017), 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
- K162256: Klassic Femur, Porous, Klassic Tibial Baseplate, Porous (2016), 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 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.

Source page: https://510kreport.com/device/K153776
Methodology: https://510kreport.com/methodology