# K030686: Optetrak Total Knee System - Molded Metal-Back Tibial Component

- Pathway: 510(k) (Special)
- Applicant: Exactech, Inc.
- Decided: Apr 2, 2003 after 28 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). 10 ancestors in all.
86 later devices descend from it; 2 cite it directly.
0 of 97 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K932776: Cruciate Retaining Cemented Tibial Components, Exactech, Inc. (1994) Summary page 1.
- K011976: Optetrak Total Knee System Size 0/1 Delta (Line Extension), Exactech, Inc. (2001)
- K933610: Exactech Cemented Total Knee System, Tibial Components, Exactech, Inc. (1995) Summary page 1.
- K833921: Agc Total Knee Prosthesis, Biomet, Inc. (1984) Summary page 1.
- K810520: Insall/Burstein Constrained Total Condyl, Zimmer, Inc. (1981) Summary page 1.

## Most influential descendants
- K100900: Motivation Knee System (2010), 72 descendants of its own
- K113756: Highly Cross Linked VE Central Peg Patella Highly Cross Linked VE Tri-Peg Patella Highly Cross Linked VE Metal Backed PA (2012), 35 descendants of its own
- K122870: Itotal Cruciate Retaining (CR) Knee Replacement System (2013), 33 descendants of its own
- K131467: Itotal Cruciate Retaining (CR) Knee Replacement System (2013), 30 descendants of its own
- K131019: Itotal Cruciate Retaining (C) Knee Replacement System (2013), 30 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 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/K030686
Methodology: https://510kreport.com/methodology