# K964008: Foundation Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Encore Orthopedics, Inc.
- Decided: Dec 27, 1996 after 81 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: 1 generation back to K923277 (1993). 1 ancestor in all.
21 later devices descend from it; 1 cites it directly.
0 of 23 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

## Most influential descendants
- K122239: Foundation Knee System with Tinbn Coating Foundation PS Knee System with Tinbn Coating 3DKNEE System with Tinbn Coating (2013), 20 descendants of its own
- K152431: LINK Endo-Model Knee System with PorEx (TiNbN) coating, Link Sled Knee System with PorEx (TiNbN) coating (2016), 9 descendants of its own
- K182872: LINK GEMINI SL Total Knee System (2019), 8 descendants of its own
- K202684: GMK Total Knee System - TiNbN Coating (2020), 3 descendants of its own
- K202924: LinkSymphoKnee System (2021), 2 descendants of its own

## Indications for use
The indications for use of this femoral insert 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.

Source page: https://510kreport.com/device/K964008
Methodology: https://510kreport.com/methodology