# K071471: Corin Adaptor Sleeve

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp.
- Decided: Sep 10, 2007 after 104 days
- Product code: KWL (Prosthesis, Hip, Hemi-, Femoral, Metal)
- Device class: 2
- Regulation: 21 CFR 888.3360
- Recalls of this device: 1 (0 Class I)
- 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) V40TM/C - Taper Adaptor Sleeve: named in the summary without a submission number
- (no number) Unitrax Unipolar System: named in the summary without a submission number

## Recalls of this device
- Jun 26, 2009 · Not classified · Z-2144-2009: The raw material used in the production of the Unipolar adaptor sleeve and the Restoration modular products are not affected by the previously mentioned metallurgical non-compliance issue. however, po

## Indications for use
The Corin Adaptor Sleeve is indicated for use with a Corin Unipolar Modular Head and a Howmedica Osteonics femoral hip stem with a V40TM trunnion in partial hip replacement procedures for patients suffering from pain and disability due to osteoarthritis, rheumatoid arthritis, avascular necrosis of the femoral head, femoral neck fracture and abnormalities where the major pathology affects the femoral head, the acetabular cavity is normal and acetabular replacement is either undesirable or not required.

Source page: https://510kreport.com/device/K071471
Methodology: https://510kreport.com/methodology