# K972995: The C-Fit & DC-Fit Acetabular Cup System

- Pathway: 510(k) (Traditional)
- Applicant: Corin USA
- Decided: Nov 10, 1997 after 90 days
- Product code: JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3350
- 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) Mallory Head Acetabular Cup range: named in the summary without a submission number

## Indications for use
Relief of pain and restoration of hip function following the effects of osteo, rheumatoid and inflammatory arthritis, post-trauma disease effects, avascular necrosis, and total hip revision. The C-Fit and DC-Fit plasma sprayed acetabular components are intended for use ONLY with bone cement.

Source page: https://510kreport.com/device/K972995
Methodology: https://510kreport.com/methodology