# K972752: Duracon Conversion Metal Backed Patella

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Corp.
- Decided: Oct 21, 1997 after 90 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) Duracon® Metal Backed Patella - Howmedica: named in the summary without a submission number
- (no number) Duracon® All Polyethylene Patella - Howmedica: named in the summary without a submission number
- (no number) PCA Modular Knee Tibial Baseplates and Tibial Inserts - Howmedica: named in the summary without a submission number
- (no number) Series 7000 Metal Backed Patella - Osteonics: named in the summary without a submission number

## Indications for use
The Duracon® Conversion Metal Backed Patella is intended to be used with Duracon® femoral and tibial components as part of a total knee system. This total knee system is intended to be used to relieve pain and instability of the knee joint as a result of non-inflammatory joint disease, inflammatory joint disease, trauma, or failed previous prosthesis. Specifically, this patellar component is intended to replace the articular surface of the natural patella in primary or revision total knee scenarios. The Duracon® Conversion Metal Backed Patella is intended to be a revisable component. The patellar component will be made available with the polyethylene insert assembled to the metal backing. Separate polyethylene patellar inserts will be made available so the physician can intraoperatively replace excessively worn polyethylene to a well-fixed metal patellar baseplate. The Duracon® Conversion Metal Backed Patella is intended to be implanted using bone cement.

Source page: https://510kreport.com/device/K972752
Methodology: https://510kreport.com/methodology