# K955877: Zimmer Zirconia Ceramic Femoral Head

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Oct 8, 1996 after 287 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.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Zimmer® Zirconia Ceramic Femoral Heads, 22 through 28 mm: named in the summary without a submission number

## Most influential descendants
- K972690: Zirconia Ceramic Femoral Head (1997), 0 descendants of its own
- K971752: Zirconia Ceramic Femoral Head (12/14 Taper) (1997), 0 descendants of its own

## Indications for use
The Zimmer Zirconia Ceramic Femoral Head is designed to be implanted into the human hip as a component in total hip arthroplasty and is indicated for the following: Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur, patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis; patients suffering from disability due to previous fusion; patients with previously failed endoprostheses and/or total hip components in the operative extremity; and patients with acute neck fractures.

Source page: https://510kreport.com/device/K955877
Methodology: https://510kreport.com/methodology