# K923277: Foundation Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Encore Orthopedics, Inc.
- Decided: Feb 9, 1993 after 218 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: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
238 later devices descend from it; 11 cite it directly.
0 of 239 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K020114: 3D KNEE (2002), 143 descendants of its own
- K091956: Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts, Model 391/392-09_19-702_712 (2010), 119 descendants of its own
- K000666: TC-Plus Solution Knee (2000), 115 descendants of its own
- K100900: Motivation Knee System (2010), 72 descendants of its own
- K022204: VKS Knee System (2002), 70 descendants of its own

## Recalls of this 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.
- Nov 3, 2005 · Not classified · Z-0331-06: The product is mislabeled in that Size 6 right Foundation may contain size 8 right 3D knee non-porous baseplates and vice versa. Device is intended to aid surgeon in relieving knee pain and restoring 
- May 10, 2004 · Not classified · Z-1010-04: Labeling is switched for the two products recalled. 3DKNEE is labeled as Foundation and Foundation is labeled as 3DKNEE
- Apr 24, 2003 · Not classified · Z-1069-03: Product container was labeled incorrectly indicating left femur instead of right.

Source page: https://510kreport.com/device/K923277
Methodology: https://510kreport.com/methodology