# K111911: Corin Optimom Modular Head

- Pathway: 510(k) (Special)
- Applicant: Corin USA
- Decided: Aug 4, 2011 after 30 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: 11 generations back to K810258 (1981). 101 ancestors in all.
62 later devices descend from it; 1 cites it directly.
0 of 163 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063791: Corin Unipolar Modular Head, Corin USA (2007) Summary page 1.
- K003666: Taper-Fit Total Hip System, Corin USA (2001) Summary page 1.
- K010243: Tri-Fit Femoral Stem, Corin USA (2001) Summary page 1.
- K110087: Corin Trinity Acetbular System with Hxlpe Liners, Corin USA (2011) Summary page 1.

## Most influential descendants
- 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
- K160907: DePuy Actis DuoFix Hip Prosthesis (2016), 26 descendants of its own

## Indications for use
The Corin Optimom 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/K111911
Methodology: https://510kreport.com/methodology