# K103120: Corin Biolox Delta Femoral Heads

- Pathway: 510(k) (Traditional)
- Applicant: Corin USA
- Decided: Feb 28, 2011 after 129 days
- Product code: LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3353
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K810258 (1981). 40 ancestors in all.
110 later devices descend from it; 5 cite it directly.
0 of 151 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992235: Zyranox Zirconia Ceramic Femoral Heads, Corin USA (1999) Summary page 1.
- K100412: Biolox Delta Ceramic Femoral Heads, Smith & Nephew, Inc. (2010) Summary page 1.

## Most influential descendants
- K110087: Corin Trinity Acetbular System with Hxlpe Liners (2011), 109 descendants of its own
- 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

## Indications for use
The Corin BIOLOX delta Modular Femoral Heads are used in combination with femoral hip stems and ultra high molecular weight polyethylene (UHI-IMWPE) acetabular cup liners to reinstate function following the degenerative effects of: Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis Rheumatoid arthritis Correction of functional deformity and Developmental dysplasia of the hip (DDH) or congenital dysplasia of the hip (CDH) The Corin I3IOLOX delta Modular Femoral Heads are intended for single use only.

Source page: https://510kreport.com/device/K103120
Methodology: https://510kreport.com/methodology