# K943025: Freeman/Samuelson Total Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Mar 13, 1996 after 625 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) AGC 2000 Total Knee Prosthesis: named in the summary without a submission number
- (no number) Maxim Knee System: named in the summary without a submission number
- (no number) Freeman/Samuelson Total Knee (Depuy): named in the summary without a submission number
- (no number) Freeman/Samuelson Mark Il Press-fit (Protek): named in the summary without a submission number

## Most influential descendants
- K020214: Medial Rotation Knee System (2002), 1 descendant of its own
- K140222: Saiph Knee System (2014), 0 descendants of its own

## Indications for use
Indications include the relief of pain and restoration of motion due to non-inflammatory degenerative joint diseases, rheumatoid arthritis, deformities of the knee and revisions of previously failed knee replacements.

Source page: https://510kreport.com/device/K943025
Methodology: https://510kreport.com/methodology