FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Avenir® Müller Stem; Avenir Complete Hip System
K Number: K260182
·
Decision Apr 27, 2026
Classifications
1
FEI Numbers
276
Registration Numbers
276
Same Product Code
530
Applicant Total
376
Review Days
96
Basic Information
- Device Name
- Avenir® Müller Stem; Avenir Complete Hip System
- K Number
- K260182
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3353
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Zimmer, Inc.
- Date Received
- January 21, 2026
- Decision Date
- April 27, 2026
- Product Code
- LZO
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
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Other Clearances by Zimmer, Inc.
| K Number | Device Name | ||
|---|---|---|---|
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| K260831 | Z1 Hip System | Jun 16, 2026 | Substantially Equivalent |
| K251840 | Zimmer® Persona® Personalized Knee System | May 28, 2026 | Substantially Equivalent |
| K253592 | Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter) | Apr 13, 2026 | Substantially Equivalent |
| K253566 | Affixus Retrograde Femoral Nailing System | Mar 12, 2026 | Substantially Equivalent |
| K253189 | Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs) | Mar 9, 2026 | Substantially Equivalent |
| K252623 | G7® Revision Acetabular System | Feb 4, 2026 | Substantially Equivalent |
| K251098 | Identity Revision Humeral Stems | Aug 11, 2025 | Substantially Equivalent |
| K251906 | Z1 Hip System | Jul 18, 2025 | Substantially Equivalent |
| K250848 | Identity Shoulder System | Jul 2, 2025 | Substantially Equivalent |