# K971721: Whiteside Biomechanics, Inc. Zirconia Ceramic Femoral Head

- Pathway: 510(k) (Traditional)
- Applicant: Whiteside Biomechanics, Inc.
- Decided: Jul 30, 1997 after 82 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
1. noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis, rheumatoid arthritis, correction of functional deformity, revision procedures where other treatments or devices have failed, treatment of non-unions, femoral neck and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques, treatment of osteomyelitis, endoprosthesis femoral osteotomy. use with a polyethylene cup with or without metal backed shell.

Source page: https://510kreport.com/device/K971721
Methodology: https://510kreport.com/methodology