# K932690: Exactech Cruciate Retaining Cemented Total Knee SY

- Pathway: 510(k) (Traditional)
- Applicant: Exactech, Inc.
- Decided: Feb 9, 1995 after 616 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: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
109 later devices descend from it; 6 cite it directly.
0 of 110 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
- Apr 18, 2024 · Class II · Z-2155-2024: Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags.
- Apr 18, 2024 · Class II · Z-2157-2024: Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags.
- Apr 18, 2024 · Class II · Z-2158-2024: Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags.
- Apr 18, 2024 · Class II · Z-2156-2024: Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags.
- 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.
- Aug 30, 2021 · Class II · Z-0019-2022: Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.

Source page: https://510kreport.com/device/K932690
Methodology: https://510kreport.com/methodology