Zimmer, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Zimmer® Persona® Personalized Knee System, Avenir® Müller Stem, Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter)
374
Total
353
Cleared
0
Denied
FDA 510(k) Regulatory Record - Zimmer, Inc. Orthopedic ✕
337 devices
Cleared
May 28, 2026
Zimmer® Persona® Personalized Knee System
Orthopedic
346d
Cleared
Apr 27, 2026
Avenir® Müller Stem
Orthopedic
96d
Cleared
Apr 13, 2026
Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings,...
Orthopedic
147d
Cleared
Mar 12, 2026
Affixus Retrograde Femoral Nailing System
Orthopedic
115d
Cleared
Mar 09, 2026
Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)
Orthopedic
164d
Cleared
Feb 04, 2026
G7® Revision Acetabular System
Orthopedic
169d
Cleared
Aug 11, 2025
Identity Revision Humeral Stems
Orthopedic
123d
Cleared
Jul 18, 2025
Z1 Hip System
Orthopedic
28d
Cleared
Jul 02, 2025
Identity Shoulder System
Orthopedic
104d
Cleared
Mar 06, 2025
Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components)
Orthopedic
93d
Cleared
Feb 12, 2025
Affixus Tibial Nailing System - 4mm screws
Orthopedic
55d
Cleared
Dec 11, 2024
OsseoFit Stemless Shoulder System
Orthopedic
167d
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