# K111400: Optetrak Logic CR Tibial Insert, Optetrak Logic CR Femoral Component

- Pathway: 510(k) (Special)
- Applicant: Exactech, Inc.
- Decided: Jul 28, 2011 after 70 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: 5 generations back to K936079 (1994). 13 ancestors in all.
12 later devices descend from it; 6 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K932690: Exactech Cruciate Retaining Cemented Total Knee SY, Exactech, Inc. (1995) Summary page 1.
- K093360: Optetrak Logic Total Knee System Trapezoidal Tibial Tray, Sizes 2.5F/1.5T-3.5F/4.5T, Exactech, Inc. (2010) Summary page 1.
- K082022: Optetrak 9MM Cruciate Retaining Tibial Insert, Slope ++, Exactech, Inc. (2008) Summary page 1.

## Most influential descendants
- K121307: Optetrak Logic CR Tibial Insert, Size 0 Optetrak Logic CR Tibial Insert, Size 6 Optetrak Logic CR Femoral Component, Siz (2012), 11 descendants of its own
- K123687: Optetrak Logic Porous Femoral Component (2013), 7 descendants of its own
- K153776: Optetrak One Logic Femoral Components (2016), 4 descendants of its own
- K123342: Optetrak Logic CRC Tibial Insert (2013), 4 descendants of its own
- K132161: Optetrak Logic PS 17MM & 19MM Thick Inserts, Optetrak Logic PSC 17MM & 19MM Thick Inserts (2013), 3 descendants of its own

## Recalls of this device
- Nov 21, 2023 · Class II · Z-0583-2024: Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.

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

Source page: https://510kreport.com/device/K111400
Methodology: https://510kreport.com/methodology