# K093360: Optetrak Logic Total Knee System Trapezoidal Tibial Tray, Sizes 2.5F/1.5T-3.5F/4.5T

- Pathway: 510(k) (Special)
- Applicant: Exactech, Inc.
- Decided: Jan 11, 2010 after 75 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: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K936079 (1994). 11 ancestors in all.
15 later devices descend from it; 7 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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.
- K033883: Optetrak Total Knee System, HI-Flex Asymmetric Posterior-Stabilized Cemented Femoral Components, HI-Flex Posterior-Stabi, Exactech, Inc. (2004) Summary page 1.
- K933494: Exactech Posterior Stabilized Cemented Total Knee System, Exactech, Inc. (1995) Summary page 1.
- K032606: Optetrak Total Knee System Asymmetric Femoral Components Size 6 Psoterior-Stabilizing, Cemented Femoral Components, Exactech, Inc. (2003) Summary page 1.

## Most influential descendants
- K111400: Optetrak Logic CR Tibial Insert, Optetrak Logic CR Femoral Component (2011), 12 descendants of its own
- 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

## 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.
- Aug 19, 2011 · Class II · Z-2310-2012: Exactech, Inc. of Gainesville, FL is recalling their Optetrak Logic Posterior Stabilized Tibial Insert, Size 6 after the device was determined to be out of dimensional specification.

## 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 revijsion of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present. The OPTETRAK Logic Total Knee System is indicated for cemented use only.

Source page: https://510kreport.com/device/K093360
Methodology: https://510kreport.com/methodology