# K954208: Optetrak Constrained Condylar Knee for Cemented Use Only

- Pathway: 510(k) (Traditional)
- Applicant: Exactech, Inc.
- Decided: Feb 26, 1996 after 172 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
110 later devices descend from it; 5 cite it directly.
0 of 111 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K011976: Optetrak Total Knee System Size 0/1 Delta (Line Extension) (2001), 107 descendants of its own
- K030686: Optetrak Total Knee System - Molded Metal-Back Tibial Component (2003), 86 descendants of its own
- 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

## Recalls of this device
- Nov 21, 2023 · Class II · Z-0582-2024: Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.

Source page: https://510kreport.com/device/K954208
Methodology: https://510kreport.com/methodology