# K032606: Optetrak Total Knee System Asymmetric Femoral Components Size 6 Psoterior-Stabilizing, Cemented Femoral Components

- Pathway: 510(k) (Special)
- Applicant: Exactech, Inc.
- Decided: Sep 23, 2003 after 29 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: 2 generations back to K936079 (1994). 8 ancestors in all.
18 later devices descend from it; 2 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)
- K932690: Exactech Cruciate Retaining Cemented Total Knee SY, Exactech, Inc. (1995) Summary page 2.
- K933494: Exactech Posterior Stabilized Cemented Total Knee System, Exactech, Inc. (1995) Summary page 2.
- K935726: Exactech Porous Coated Cruciate Retained Femoral Component, Exactech, Inc. (1994) Summary page 2.
- K011976: Optetrak Total Knee System Size 0/1 Delta (Line Extension), Exactech, Inc. (2001)

## Most influential descendants
- K033883: Optetrak Total Knee System, HI-Flex Asymmetric Posterior-Stabilized Cemented Femoral Components, HI-Flex Posterior-Stabi (2004), 17 descendants of its own
- K093360: Optetrak Logic Total Knee System Trapezoidal Tibial Tray, Sizes 2.5F/1.5T-3.5F/4.5T (2010), 15 descendants of its own
- 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

## Indications for use
The OPTETRAK@Total Knee Systems are indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis andor 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/K032606
Methodology: https://510kreport.com/methodology