# K063791: Corin Unipolar Modular Head

- Pathway: 510(k) (Traditional)
- Applicant: Corin USA
- Decided: Apr 3, 2007 after 102 days
- Product code: KWL (Prosthesis, Hip, Hemi-, Femoral, Metal)
- Device class: 2
- Regulation: 21 CFR 888.3360
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K902365 (1991). 4 ancestors in all.
63 later devices descend from it; 1 cites it directly.
0 of 68 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K940190: Ultima Unipolar Modular Head, Johnson & Johnson Orthopaedics, Inc. (1994) Summary page 1.
- K902365: Modular Unipolar System, Howmedica Corp. (1991) Summary page 1.
- K992570: Unitrax C-Taper Neck Adjustment Sleeve, Howmedica Osteonics Corp. (1999) Summary page 1.
- K910988: Osteonics Ion Implanted Femoral Bearing Series, Osteonics Corp. (1991) Summary page 1.

## Most influential descendants
- K111911: Corin Optimom Modular Head (2011), 62 descendants of its own
- K120362: Metafix Femoral Stem for Hemi-Arthroplasty (2012), 61 descendants of its own
- K123991: Depuy Corail Amt Hip Prosthesis (2013), 48 descendants of its own
- K150862: DePuy Actis Duofox Hip Prosthesis (2015), 38 descendants of its own
- K170339: Summit Hip System (2018), 27 descendants of its own

## Indications for use
The Corin Unipolar Modular Head is indicated for hemi-arthroplasty in cemented and uncemented primary or revision femoral stem applications whose indications include procedures for patients suffering 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/K063791
Methodology: https://510kreport.com/methodology