# K260182: Avenir® Müller Stem; Avenir Complete™ Hip System

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Apr 27, 2026 after 96 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: 9 generations back to K935452 (1994). 64 ancestors in all.
No later device cites it as a predicate yet.
0 of 65 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 6.
- K182048: Avenir Complete Hip System, Zimmer, Inc. (2018) Summary page 6.
- K192189: Avenir Complete Hip System, Size 0 Coxa Vara, Zimmer, Inc. (2019) Summary page 6.

## Indications for use
The Avenir Müller Uncemented Hip Stems are intended for cementless use in total or hemi hip arthroplasty and are indicated for the following conditions: • Noninflammatory degenerative joint disease (NIDJD), e.g. avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g. rheumatoid arthritis. • Acute traumatic fracture of the femoral head or neck. The Avenir Complete Hip System is intended for cementless use in in total or hemi hip arthroplasty and is indicated in 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/K260182
Methodology: https://510kreport.com/methodology