FDA Product Code MBH: Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer
Under FDA product code MBH, semi-constrained patello/femorotibial knee prostheses are cleared for total knee arthroplasty with patellar resurfacing.
These implant systems include components for the femur, tibia, and patella, restoring all three compartments of the knee joint. They are designed to provide stability, range of motion, and durability in patients with tricompartmental arthritis.
MBH devices are Class II medical devices, regulated under 21 CFR 888.3565 and reviewed by the FDA Orthopedic panel.
Leading manufacturers include Zimmer, Inc., Smith & Nephew, Inc. and Howmedica Osteonics Corp..
143
Total
143
Cleared
119d
Avg days
2003
Since
143 devices
Cleared
May 28, 2004
SCORPIO TOTAL KNEE SYSTEM WITH PERI-APATITE COATING
Howmedica Osteonics Corp.
Orthopedic
158d
Cleared
Apr 12, 2004
SCORPIO TOTAL KNEE SYSTEM
Howmedica Osteonics Corp.
Orthopedic
112d
Cleared
Jan 15, 2004
SEARCH EVOLUTION (LC) TOTAL KNEE SYSTEM (POROUS COATED)
Aesculap, Inc.
Orthopedic
191d
Cleared
Oct 15, 2003
GENESIS II POROUS PLUS HA KNEE SYSTEM
Smith & Nephew, Inc.
Orthopedic
47d
Cleared
Oct 09, 2003
NEXGEN POROUS, UNCEMENTED FEMORAL AND TIBIAL BASEPLATE COMPONENTS
Zimmer, Inc.
Orthopedic
189d
Cleared
Sep 12, 2003
DURACON TOTAL KNEE SYSTEM
Howmedica Osteonics Corp.
Orthopedic
59d
Cleared
Sep 11, 2003
DURACON TOTAL KNEE SYSTEM WITH PERI-APATITE COATING
Howmedica Osteonics Corp.
Orthopedic
37d
Cleared
May 27, 2003
GENESIS II TOTAL KNEE SYSTEM
Smith & Nephew, Inc.
Orthopedic
90d
Cleared
May 22, 2003
SMITH & NEPHEW PROFIX TOTAL KNEE SYSTEM
Smith & Nephew, Inc.
Orthopedic
84d