# K260831: Z1 Hip System

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Jun 16, 2026 after 95 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: 11 generations back to K935452 (1994). 65 ancestors in all.
No later device cites it as a predicate yet.
0 of 66 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K251906: Z1 Hip System, Zimmer, Inc. (2025) Summary page 5.
- K233476: Z1 Hip System, Orchard Medical Development (2024) Summary page 5.

## Indications for use
Z1 Hip System is intended for total or hemi hip arthroplasty and is indicated for the following conditions: • Advanced wear of the joint due to degenerative, post-traumatic or rheumatic diseases. • Failed previous hip surgery including joint reconstruction (osteotomy), arthrodesis, hemi-arthroplasty or total hip replacement (THR). • Acute traumatic fracture of the femoral head or neck. • Avascular necrosis of the femoral head.

Source page: https://510kreport.com/device/K260831
Methodology: https://510kreport.com/methodology