# K970031: Foundation Knee System Tibial Component

- Pathway: 510(k) (Traditional)
- Applicant: Encore Orthopedics, Inc.
- Decided: Apr 2, 1997 after 89 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
Longest line of descent: 1 generation back to K923277 (1993). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K923277: Foundation Knee System, Encore Orthopedics, Inc. (1993) Summary page 1.
- (no number) Biomet Maxim® Knee System: named in the summary without a submission number

## Recalls of this device
- Oct 26, 2011 · Not classified · Z-0349-2012: The strike plate may dislodge from the broach stem handle during impaction of the device.
- Aug 4, 2008 · Not classified · Z-2466-2008: Complaints received regarding the fracture of the Nitronic 60 screw on the Tibial Fixed Impactor during surgery.

## Indications for use
The indications for use of these tibial inserts are noninflammatory degenerative joint disease including osteoarthritis or traumatic 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, rheumatoid arthritis, treatment of fractures that are unmanageable using other techniques. This device is for cemented use only.

Source page: https://510kreport.com/device/K970031
Methodology: https://510kreport.com/methodology