# K991708: Zirconia 22.22MM Ceramic Modular Heads

- Pathway: 510(k) (Abbreviated)
- Applicant: Biomet, Inc.
- Decided: Jul 30, 1999 after 72 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: 1 generation back to K964431 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964431: Zirconia Ceramic Modular Heads (Norton Advanced Ceramics), Biomet, Inc. (1997) Summary page 2.

## Indications for use
The indications for use of the Zirconia Ceramic Modular Heads include: 1) noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis, 2) rheumatoid arthritis, 3) correction of functional deformity, and 4) revision of failed hip arthroplasty.

Source page: https://510kreport.com/device/K991708
Methodology: https://510kreport.com/methodology