MBH · Class II · 21 CFR 888.3565

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..

144
Total
144
Cleared
120d
Avg days
2003
Since
144 devices
121–144 of 144
Cleared Aug 11, 2006
TRIATHLON METAL BACKED PATELLA
K061521
Howmedica Osteonics Corp.
Orthopedic · 70d
Cleared Mar 30, 2006
VANGUARD PS OPEN BOX POROUS FEMORAL COMPONENTS
K060303
Biomet Manufacturing Corp
Orthopedic · 52d
Cleared Mar 22, 2006
SIGNAL MEDICAL CORPORATION BEACON KNEE SYSTEM
K051510
Signal Medical Corp.
Orthopedic · 288d
Cleared Aug 30, 2005
TRIATHLON PRESS-FIT TOTAL KNEE SYSTEM
K051380
Howmedica Osteonics Corp.
Orthopedic · 95d
Cleared Aug 16, 2005
VANGUARD ANTERIOR STABILIZED TIBIAL BEARINGS
K050222
Biomet, Inc.
Orthopedic · 197d
Cleared Apr 18, 2005
ADVANCE HA COATED SPIKED TIBIAL BASE AND ADVANCE HA COATED MODULAR KEEL
K043083
Wrightmedicaltechnologyinc
Orthopedic · 161d
Cleared Feb 16, 2005
DURACON CONVERSION AND X-SMALL SYMMETRIC PATELLA WITH PERI-APATITE COATING
K043374
Howmedica Osteonics Corp.
Orthopedic · 70d
Cleared Dec 21, 2004
TRABECULAR METAL KNEE SYSTEM AUGMENTS
K040487
Implex Corp.
Orthopedic · 300d
Cleared Oct 29, 2004
NEXGEN POROUS, HA/TCP, UNCEMENTED FEMORAL AND TIBIAL BASEPLATE COMPONENTS
K041100
Zimmer, Inc.
Orthopedic · 185d
Cleared Sep 08, 2004
ASCENT POROUS OPEN BOX PS COMPONENT/ASCENT POSTERIOR STABALIZED (PS) DISTAL FEMORAL PEGS
K041872
Biomet Manufacturing Corp
Orthopedic · 61d
Cleared Jul 06, 2004
3DKNEE POROUS COATED FEMORAL COMPONENT
K032905
Encore Orthopedics, Inc.
Orthopedic · 293d
Cleared Jun 02, 2004
AGC TOTAL KNEE SYSTEM KNEE, ASCENT TOTAL KNEE SYSTEM, MAXIM COMPLETE KNEE SYSTEM, MAXIM ACCEL KNEE SYSTEM ALSO KNOWN
K033489
Biomet, Inc.
Orthopedic · 211d
Cleared May 28, 2004
SCORPIO TOTAL KNEE SYSTEM WITH PERI-APATITE COATING
K033971
Howmedica Osteonics Corp.
Orthopedic · 158d
Cleared Apr 12, 2004
SCORPIO TOTAL KNEE SYSTEM
K033972
Howmedica Osteonics Corp.
Orthopedic · 112d
Cleared Jan 15, 2004
SEARCH EVOLUTION (LC) TOTAL KNEE SYSTEM (POROUS COATED)
K032108
Aesculap, Inc.
Orthopedic · 191d
Cleared Oct 15, 2003
GENESIS II POROUS PLUS HA KNEE SYSTEM
K032683
Smith & Nephew, Inc.
Orthopedic · 47d
Cleared Oct 09, 2003
NEXGEN POROUS, UNCEMENTED FEMORAL AND TIBIAL BASEPLATE COMPONENTS
K031061
Zimmer, Inc.
Orthopedic · 189d
Cleared Sep 12, 2003
DURACON TOTAL KNEE SYSTEM
K032163
Howmedica Osteonics Corp.
Orthopedic · 59d
Cleared Sep 11, 2003
DURACON TOTAL KNEE SYSTEM WITH PERI-APATITE COATING
K032418
Howmedica Osteonics Corp.
Orthopedic · 37d
Cleared Aug 06, 2003
THE NEXGEN KNEE SYSTEM UNCEMENTED COMPONENTS
K031462
Implex Corp.
Orthopedic · 90d
Cleared May 27, 2003
GENESIS II TOTAL KNEE SYSTEM
K030612
Smith & Nephew, Inc.
Orthopedic · 90d
Cleared May 22, 2003
SMITH & NEPHEW PROFIX TOTAL KNEE SYSTEM
K030623
Smith & Nephew, Inc.
Orthopedic · 84d