# K971752: Zirconia Ceramic Femoral Head (12/14 Taper)

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Jul 30, 1997 after 79 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 K901480 (1990). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K944601: Zimmer Zirconia Ceramic Femoral Head, Zimmer, Inc. (1995) Summary page 1.
- K955877: Zimmer Zirconia Ceramic Femoral Head, Zimmer, Inc. (1996) Summary page 1.
- K901480: F-20 Total Hip Prosthesis, Med-Tek Corp. (1990) Summary page 1.
- K901594: H.N. Total Hip Prosthesis, Med-Tek Corp. (1990) Summary page 1.
- K953337: Beta Hip Prosthesis, Zimmer, Inc. (1996) Summary page 2.

## Indications for use
The 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/K971752
Methodology: https://510kreport.com/methodology