# K012251: Optetrak Total Knee System, Straight Stem Extensions - Additional Sizes

- Pathway: 510(k) (Special)
- Applicant: Exactech, Inc.
- Decided: Jul 31, 2001 after 13 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 K933610 (1995). 2 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 7 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 2.
- K954208: Optetrak Constrained Condylar Knee for Cemented Use Only, Exactech, Inc. (1996) Summary page 2.

## Most influential descendants
- K150890: Exactech Optetrak Logic CC (2015), 3 descendants of its own
- K152170: Exactech Optetrak Logic Enhanced Assembly (2015), 2 descendants of its own
- K171045: Exactech® Truliant™ Line Extensions (2017), 1 descendant of its own
- K223252: TRULIANT® E-PX Tibial Inserts; TRULIANT® E-PX Patellas (2023), 0 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. CAUTION: For cemented use only in the USA.

Source page: https://510kreport.com/device/K012251
Methodology: https://510kreport.com/methodology