FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ZIMMER TRABECULAR METAL TOTAL ANKLE
K Number: K120906
·
Decision Aug 24, 2012
Classifications
1
FEI Numbers
92
Registration Numbers
92
Same Product Code
67
Applicant Total
376
Review Days
151
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- ZIMMER TRABECULAR METAL TOTAL ANKLE
- K Number
- K120906
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3110
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Zimmer, Inc.
- Date Received
- March 26, 2012
- Decision Date
- August 24, 2012
- Product Code
- HSN
- 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 |
|---|---|---|---|
| HSN | Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HSN), ordered by most recent decision date.
Prophecy Incompass Surgical Planning System
FDA 510(k)
FDA Class 2
·Orthopedic
Kinos Total Ankle System
FDA 510(k)
FDA Class 2
·Orthopedic
Incompass Total Ankle System
FDA 510(k)
FDA Class 2
·Orthopedic
APEX 3D Total Ankle Replacement System
FDA 510(k)
FDA Class 2
·Orthopedic
Hintermann Series H2 Total Ankle System
FDA 510(k)
FDA Class 2
·Orthopedic
Prophecy Surgical Planning System
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Zimmer, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K261683 | Augment Off-Axis Instrument System | Jun 16, 2026 | Substantially Equivalent |
| K260831 | Z1 Hip System | Jun 16, 2026 | Substantially Equivalent |
| K251840 | Zimmer® Persona® Personalized Knee System | May 28, 2026 | Substantially Equivalent |
| K260182 | Avenir® Müller Stem; Avenir Complete Hip System | Apr 27, 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 |