# K233476: Z1 Hip System

- Pathway: 510(k) (Traditional)
- Applicant: Orchard Medical Development
- Decided: Feb 8, 2024 after 106 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K935452 (1994). 63 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 66 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182048: Avenir Complete Hip System, Zimmer, Inc. (2018) Summary page 5.
- K192189: Avenir Complete Hip System, Size 0 Coxa Vara, Zimmer, Inc. (2019) Summary page 5.

## Most influential descendants
- K251906: Z1 Hip System (2025), 1 descendant of its own
- K260831: Z1 Hip System (2026), 0 descendants of its own

## Recalls of this device
- Feb 12, 2025 · Class II · Z-1329-2025: There is a potential design issue with the Z1 Offset Stem Inserter leading to fracturing of the distal tip.

## 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. Z1 Hip System is for cementless use only.

Source page: https://510kreport.com/device/K233476
Methodology: https://510kreport.com/methodology