# K153595: Optetrak Logic Metaphyseal Cones

- Pathway: 510(k) (Traditional)
- Applicant: Exactech, Inc.
- Decided: Mar 25, 2016 after 100 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: 6 generations back to K982302 (1998). 15 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143393: Triathlon Tritanium Cone Augments, Stryker Orthopaedics (2015) Summary page 4.

## Most influential descendants
- K182346: TRULIANT Porous Tibial Tray and Exactech Alteon Bone Screws (2018), 5 descendants of its own
- K241597: Freedom® Total Knee System - Porous Tibial Base Plate (2025), 3 descendants of its own
- K251717: Freedom® Total Knee System – Titanium Tibial Base Plate (2025), 1 descendant of its own
- K200113: LINK TrabecuLink Tibial Cones (2020), 1 descendant of its own
- K252777: Freedom Metaphyseal Cone Implants (Metaphyseal Cones) (2025), 0 descendants of its own

## Indications for use
The Optetrak Logic Femoral and Tibial Metaphyseal Cones 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. The Cones are intended for press-fit or cemented fixation with the proximal tibial or distal femur. The final implant construct is completed by cementing a tibial tray or femoral component in place.

Source page: https://510kreport.com/device/K153595
Methodology: https://510kreport.com/methodology