# K123392: Avenir Muller Stem

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer GmbH
- Decided: Mar 4, 2013 after 122 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: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K935452 (1994). 60 ancestors in all.
41 later devices descend from it; 6 cite it directly.
0 of 102 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042992: Corail Amt Hip Prosthesis, DePuy Orthopaedics, Inc. (2005) Summary page 2.
- K071723: Zimmer Porolock Mis Stem, Zimmer GmbH (2008) Summary page 2.

## Most influential descendants
- K130899: Biolox Delta Ceramic Femoral Heads (2013), 19 descendants of its own
- K161635: AMIStem-H Proximal Coating (2017), 10 descendants of its own
- K173794: AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P Collared (2018), 9 descendants of its own
- K163577: Ecofit® Hip System (2017), 9 descendants of its own
- K181254: Quadra P (2018), 7 descendants of its own

## Recalls of this device
- Oct 31, 2018 · Class II · Z-0644-2019: Mislabeled Labeled Avenir Mller Stem size 1, the stem inside the packaging is an Avenir Mller Stem size 2 .
- Feb 28, 2018 · Class II · Z-1524-2018: A potential commingle that could result in the product in the package not matching the product on the outer label.
- Feb 28, 2018 · Class II · Z-1525-2018: A potential commingle that could result in the product in the package not matching the product on the outer label.
- Jun 30, 2016 · Class II · Z-2292-2016: Product mix-up. The Avenir M¿ller Stem 6 lateral uncemented might be placed in the packaging of the Avenir M¿ller Stem 4 standard uncemented and vice versa. Potential for delay in surgery, and/or pote

## Indications for use
* 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 MUller Sterns are for cementless use only.

Source page: https://510kreport.com/device/K123392
Methodology: https://510kreport.com/methodology