# K933494: Exactech Posterior Stabilized Cemented Total Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Exactech, Inc.
- Decided: Mar 10, 1995 after 599 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: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
108 later devices descend from it; 4 cite it directly.
0 of 109 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
- Aug 30, 2021 · Class II · Z-0019-2022: Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.
- Dec 7, 2006 · Not classified · Z-0522-2007: The outside profile on this manufactured lot of devices is oversized and does not meet specifications.

Source page: https://510kreport.com/device/K933494
Methodology: https://510kreport.com/methodology