# K182048: Avenir Complete Hip System

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Dec 7, 2018 after 129 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: 7 generations back to K935452 (1994). 61 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 67 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123392: Avenir Muller Stem, Zimmer GmbH (2013) Summary page 4.
- K042992: Corail Amt Hip Prosthesis, DePuy Orthopaedics, Inc. (2005) Summary page 4.

## Most influential descendants
- K192189: Avenir Complete Hip System, Size 0 Coxa Vara (2019), 4 descendants of its own
- K233476: Z1 Hip System (2024), 2 descendants of its own
- K251906: Z1 Hip System (2025), 1 descendant of its own
- K260831: Z1 Hip System (2026), 0 descendants of its own
- K260182: Avenir® Müller Stem; Avenir Complete™ Hip System (2026), 0 descendants of its own

## Indications for use
Avenir Complete 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. Avenir Complete Hip System is for cementless use only.

Source page: https://510kreport.com/device/K182048
Methodology: https://510kreport.com/methodology
