# K971550: Kinematic All-Polyethylene Patella with Three Pegs

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Corp.
- Decided: Jul 8, 1997 after 71 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) Kinematic® All Poly Patella: named in the summary without a submission number
- (no number) Duracon® All Polyethylene Patella Il: named in the summary without a submission number

## Indications for use
The Kinematic® All-Polyethylene Patella with Three Pegs is intended to be used with the femoral and tibial components of the Kinematic® and Kinematic® Il total knee systems, and the distal femoral component of the Howmedica Modular Replacement System in primary and/or revision total knee arthroplasty. This component is intended to resurface the articular surface of the patella. It is intended to be implanted with bone cement.

Source page: https://510kreport.com/device/K971550
Methodology: https://510kreport.com/methodology