# K093567: Active Knee Total Knee Replacement System

- Pathway: 510(k) (Traditional)
- Applicant: Anova Implant Solutions, LLC
- Decided: Feb 5, 2010 after 79 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: 2 generations back to K973412 (1997). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021740: Total Knee Cemented, Semi-Constrained, Dj Orthopedics, LLC (2002) Summary page 1.

## Indications for use
The Active Knee Total Knee Replacement System is indicated to be used only with bone cement in patients suffering from the following conditions: * Noninflarnmatory degenerative joint disease including osreoarthritis, traumatic arthritis, or avascular necrosis. * Inflammatory degenerative joint disease including rheumatoid arthritis. * Correction of functional deformity such as varus, valgus, or flexion deformities. * Revision procedures where other treatments or devices have failed. * Treatment of fractures that are unmanageable using other techniques. The device is intended for single use only.

Source page: https://510kreport.com/device/K093567
Methodology: https://510kreport.com/methodology