FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Porous Patella
K Number: K212941
·
Decision Jan 20, 2022
Classifications
1
FEI Numbers
219
Registration Numbers
219
Same Product Code
142
Applicant Total
1
Review Days
127
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
- Porous Patella
- K Number
- K212941
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3565
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Encore Medical, L.P. Dba Djo Surgical
- Date Received
- September 15, 2021
- Decision Date
- January 20, 2022
- Product Code
- MBH
- 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 |
|---|---|---|---|
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MBH), ordered by most recent decision date.
Zimmer® Persona® Personalized Knee System
FDA 510(k)
FDA Class 2
·Orthopedic
Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)
FDA 510(k)
FDA Class 2
·Orthopedic
GMK 3D Metal Tibial Tray Extension
FDA 510(k)
FDA Class 2
·Orthopedic
Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing Insert
FDA 510(k)
FDA Class 2
·Orthopedic
Active-V Total Knee System; World Total Knee System
FDA 510(k)
FDA Class 2
·Orthopedic
Balanced Knee System TriMax Porous Femoral Components
FDA 510(k)
FDA Class 2
·Orthopedic