# K063406: Encore Knee System Ifu

- Pathway: 510(k) (Traditional)
- Applicant: Encore Medical L.P.
- Decided: Jan 8, 2007 after 60 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
Joint replacement is indicated for patients suffering from disability due to: · degenerative; post-traumatic or rheumatoid arthritis; * avascular necrosis of the femoral condyle; * post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy; · moderate valgus, varus or flexion deformities; This device may also be indicated in the salvage of previously failed surgical attempts. While knee replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients.

Source page: https://510kreport.com/device/K063406
Methodology: https://510kreport.com/methodology