# K941306: Foundation Knee Augmentation Blocks

- Pathway: 510(k) (Traditional)
- Applicant: Encore Orthopedics, Inc.
- Decided: Feb 8, 1995 after 328 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K161945: EXPRT Revision Knee Femoral Augment (5mm), EXPRT Revision Knee Stem Extension (40mm) (2016), 0 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.

Source page: https://510kreport.com/device/K941306
Methodology: https://510kreport.com/methodology