# K131884: Avenir Cemented Hip Stem

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer GmbH
- Decided: Aug 22, 2013 after 58 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). 65 ancestors in all.
1 later device descends from it; 1 cites 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)
- K993043: MS-30 Femoral Stem, Sulzer Orthopedics, Inc. (1999) Summary page 1.
- K020713: MS-30 Lateral Femoral Stem, Sulzer Orthopedics, Inc. (2002) Summary page 1.
- K040803: MS-30 Femoral Stem Standard and Lateral, Zimmer, Inc. (2004) Summary page 1.
- K123392: Avenir Muller Stem, Zimmer GmbH (2013) Summary page 2.

## Cited in the summary but kept off the family tree
- K010078: Guthrie Shield Plus Blue Latex Examination Gloves (Powder-Free), Guthrie Medicare Products (Melaka) Sdn Bhd (2001). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K182462: Exactech Alteon Highly Polished Femoral Stem (2018), 0 descendants of its own

## Indications for use
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, hemniarthroplasty 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/K131884
Methodology: https://510kreport.com/methodology