# K964431: Zirconia Ceramic Modular Heads (Norton Advanced Ceramics)

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Aug 11, 1997 after 279 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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) Zirconia Ceramic Heads (Type I Taper) (Biomet, Warsaw, IN): named in the summary without a submission number
- (no number) Zirconia Femoral Heads (Smith & Nephew Richards, Memphis, TN): named in the summary without a submission number
- (no number) Biolox® Al₂O₃ Ceramic Femoral Heads (Dow Corning Wright, Arlington, TN): named in the summary without a submission number
- (no number) Biolox® Al₂O₃ Ceramic Femoral Heads (Smith and Nephew Richards, Memphis, TN): named in the summary without a submission number
- (no number) Modular Ceramic Heads (DePuy, Warsaw, IN): named in the summary without a submission number
- (no number) Modular Ceramic Heads (Thackray, Orlando, FL): named in the summary without a submission number
- (no number) Modular Ceramic Heads (Protek, Indianapolis, IN): named in the summary without a submission number

## Most influential descendants
- K991708: Zirconia 22.22MM Ceramic Modular Heads (1999), 0 descendants of its own

## Indications for use
The Zirconia Ceramic Modular Heads (Norton Advanced Ceramics) are indicated for use in Non-inflammatory Degenerative Joint Disease including osteoarthritis and avascular necrosis, Rheumatoid Arthritis, correction of functional deformity, and revision of failed hip arthroplasty. This device is a single use implant.

Source page: https://510kreport.com/device/K964431
Methodology: https://510kreport.com/methodology