# K990183: Implex Alumina Femoral Head

- Pathway: 510(k) (Traditional)
- Applicant: Implex Corp.
- Decided: Jun 11, 1999 after 142 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
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 no predicate by number.

## Indications for use
The Implex Alumina Femoral Head is intended to provide articulation in total hip procedures in cases of: 1. Severely disabled joints as a result of degenerative arthritis or avascular necrosis. 2. Secondary revision of a previously unsuccessful femoral component or total hip replacement. 3. Other hip problems where clinical experience has shown that alternative modes of treatment are less likely to achieve satisfactory results. 4. Fracture dislocation of the hip or irreducible fractures in which adequate fixation cannot be obtained. 5. Non-Union of femoral neck or head fractures. 6. Salvage of a failed primary or secondary total hip or hemi-hip arthroplasty.

Source page: https://510kreport.com/device/K990183
Methodology: https://510kreport.com/methodology