# K042035: Alumina Head

- Pathway: 510(k) (Traditional)
- Applicant: Fournitures Hospitalieres Industrie
- Decided: Nov 17, 2004 after 111 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: 6 generations back to K933275 (1994). 26 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012918: Apex Modular Alumina Femoral Head, Apex Surgical, LLC (2001)
- K981847: Biolox Alumina Ceramic Femoral Head, Smith & Nephew, Inc. (1998) Summary page 2.
- K991162: Biolox Alumina Ceramic Femoral Head, Smith & Nephew, Inc. (2000) Summary page 2.
- K990261: Plus Ceramic Head Prostheses (Alumina and Zirkonia), Plus Orthopedics (1999) Summary page 2.

## Most influential descendants
- K050556: Alumina Head (2005), 0 descendants of its own

## Indications for use
Prosthetic replacement of the femoral head associated with a hip prosthesis having a taper compatible with the head taper, and with a prosthetic acetabulum having an inside diameter compatible with that of the head. The alumina head can only be used with polyethylene inserts. This prothesis may be used for degenerative joint disease such as osteoarthritis and avascular necrosis, correction of functional deformity, rheumatoid arthritis, revision procedure where other devices or treatments have failed, congenital dislocation, femoral neck and trochanteric fractures, traumatic arthritis, fused hip, diastrophic variant, slipped capital epiphysis, non-union.

Source page: https://510kreport.com/device/K042035
Methodology: https://510kreport.com/methodology