# K972643: Depuy Amk 3 Peg Patella

- Pathway: 510(k) (Traditional)
- Applicant: Depuy, Inc.
- Decided: Jan 21, 1998 after 190 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.
No later device cites it as a predicate yet.
0 of 1 device 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) DePuy AMK All Polyethylene Patella: named in the summary without a submission number
- (no number) DePuy LCS 3 Peg Patella: named in the summary without a submission number
- (no number) Johnson & Johnson PFC Oval Sombrero Patella: named in the summary without a submission number
- (no number) Zimmer NexGen All Polyethylene Patella: named in the summary without a submission number

## Indications for use
The DePuy AMK 3 Peg Patella is intended for use with the DePuy AMK Total Knee System for cemented, tricompartmental total knee arthroplasty, utilizing the AMK system's existing femoral components, tibial trays, and tibial inserts. The AMK system is intended to replace severely disabled or painful joints resulting from osteoarthritis or post-traumatic arthritis, joints with correctable varus or valgus deformity and joints with failed previous surgeries where pain, deformity or dysfunction persist.

Source page: https://510kreport.com/device/K972643
Methodology: https://510kreport.com/methodology