# K082022: Optetrak 9MM Cruciate Retaining Tibial Insert, Slope ++

- Pathway: 510(k) (Special)
- Applicant: Exactech, Inc.
- Decided: Sep 2, 2008 after 48 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: 1 generation back to K932690 (1995). 1 ancestor in all.
13 later devices descend from it; 1 cites it directly.
0 of 15 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 2.

## 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

## 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, Qsteonecrosis, 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.

Source page: https://510kreport.com/device/K082022
Methodology: https://510kreport.com/methodology