# K193030: Avenir Muller Stem, Avenir Cemented Hip Stem

- Pathway: 510(k) (Special)
- Applicant: Zimmer GmbH
- Decided: Dec 6, 2019 after 37 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.
3 later devices descend from it; 3 cite it directly.
0 of 65 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 5.

## Most influential descendants
- K260182: Avenir® Müller Stem; Avenir Complete™ Hip System (2026), 0 descendants of its own
- K241241: Z1 Cemented Hip System (2024), 0 descendants of its own
- K200112: Zimmer Hip Joint Replacement (2020), 0 descendants of its own

## Indications for use
• Advanced wear of the joint due to degenerative, post-traumatic or rheumatic diseases. • Failed previous hip surgery (not THA) where pain, deformity, or dysfunction persists. • Optional use in revision: in some medical conditions (e.g., early revision when healthy and good bone stock exists), the surgeon may opt to use primary implants in a revision procedure. • Acute traumatic fracture of the femoral head or neck. • Avascular necrosis of the femoral head. Avenir® Müller Stems are for cementless use only. The product is intended for total or hemi hip arthroplasty with cemented applications for rehabilitating hips damaged as a result of: • Advanced wear of the joint due to degenerative, post-traumatic, or rheumatic diseases • Failed previous hip surgery including joint reconstruction (osteotomy), arthrodesis, hemiarthroplasty 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/K193030
Methodology: https://510kreport.com/methodology