# K970846: 22.2/+4MM CO CR & Zirconia Femoral Head

- Pathway: 510(k) (Traditional)
- Applicant: Landos, Inc.
- Decided: Jun 5, 1997 after 90 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 K935185 (1994). 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)
- K935185: Morphometric Total Hip Prosthesis, Landos, Inc. (1994) Summary page 1.

## Indications for use
The intended use for the 22.2/+4 Femoral Head is to complete the assembly of a Ti-6Al-4V semi-constrained femoral hip stem with a 9/11 Morse-like taper, identical to the taper of the Morphometric Hip, manufactured by Medinov-AMP. The indications for use are arthritis, arthrosis or any joint disease at the hip level, osteosynthesis, failed previous surgery or joint reconstruction.

Source page: https://510kreport.com/device/K970846
Methodology: https://510kreport.com/methodology