# K241241: Z1 Cemented Hip System

- Pathway: 510(k) (Traditional)
- Applicant: Orchard Medical Development, LLC
- Decided: Aug 27, 2024 after 116 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: 8 generations back to K935452 (1994). 62 ancestors in all.
No later device cites it as a predicate yet.
0 of 63 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193030: Avenir Muller Stem, Avenir Cemented Hip Stem, Zimmer GmbH (2019) Summary page 5.

## Indications for use
Z1 Cemented Hip System is intended for total or partial (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 Cemented Hip System consists of implants that are for cemented use only.

Source page: https://510kreport.com/device/K241241
Methodology: https://510kreport.com/methodology