# K980545: The Nuffield Total Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Corin USA
- Decided: Apr 29, 1998 after 76 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 Knee System: named in the summary without a submission number
- (no number) Nuffield Total Knee System: named in the summary without a submission number

## Indications for use
Relief of pain and restoration of knee function following the effects of osteo-, rheumatoid and inflammatory arthritis, post-trauma disease effects, avascular necrosis, and total knee revision with or without varus, valgus or flexion deformity. The tibial and femoral components are intended for use only with bone cement.

Source page: https://510kreport.com/device/K980545
Methodology: https://510kreport.com/methodology