Device type
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Product code MBH · Class II · 21 CFR 888.3565 · Orthopedic
Recent 510(k)s
Sep 17, 2026
K261275
Unity Total Knee System, Unity Knee Cementless CR Femur
Corin, Ltd.
- MBH
- Class II
Sep 8, 2026
K261462
LANDMARK Total Knee System
Smith & Nephew, Inc.
- MBH
- Class II
Aug 21, 2026
K253728
EVOLUTION® AM BIOFOAM® Tibial System
Microport Orthopedics, Inc.
- MBH
- Class II
Recent recalls
Sep 23, 2026
Z-3203-2026
SCORPIO RECESSED METAL BACKED PATELLA 3045-0026 3045-0028 3045-0030 3045-0032 Orthopaedic implant components manufactured from UHMWPE (polyethylene)
Howmedica Osteonics Corp.
- MBH
- Class II
- Ongoing