Avenir® Müller Stem; Avenir Complete Hip System— 510(k) K260182
Substantially EquivalentZimmer, Inc.
FDA 510(k) clearance K260182 for Avenir® Müller Stem; Avenir Complete Hip System, Substantially Equivalent on 2026-04-27. Applicant: Zimmer, Inc.. Device class: 2.
Summary
Zimmer's record names two items: the Avenir Müller Stem and the Avenir Complete Hip System. Both are filed under product code LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented).
Class II, 21 CFR 888.3353. Orthopedic is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Zimmer filed from Warsaw, Indiana. The decision came 96 calendar days after FDA received it (January 21 to April 27, 2026).
Clearance details
- Applicant
- Zimmer, Inc.
- Product code
- Product code LZO
- Device class
- Class 2
- Regulation
- 21 CFR 888.3353
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Warsaw, IN, US
Recent devices under product code LZO
view allMore clearances from Zimmer, Inc.
view all- K262955 — OsseoFit Stemless Shoulder System
- K261683 — Augment Off-Axis Instrument System
- K251840 — Zimmer® Persona® Personalized Knee System
- K253592 — Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter)
- K253566 — Affixus Retrograde Femoral Nailing System
Adverse events under product code LZO
product code LZO- Death
- 17
- Injury
- 12,942
- Malfunction
- 1,756
- Total
- 14,715
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.