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..

146
Total
146
Cleared
121d
Avg days
2003
Since
146 devices
97–120 of 146
Cleared May 19, 2011
STRYKER PATIENT SPECIFIC CUTTING GUIDE
K110533
Stryker Corp.
Orthopedic · 84d
Cleared Feb 15, 2011
TRABECULAR METAL FEMORAL CONE AUGMENTS
K103517
Zimmer Trabecular Metal Technology, Inc.
Orthopedic · 77d
Cleared Jan 26, 2011
CONSENSUS KNEE SYSTEM
K102927
Consensus Orthopedics, Inc.
Orthopedic · 114d
Cleared Dec 13, 2010
TRABECULAR METAL TIBIAL CONE AUGMENTS
K102896
Zimmer Trabecular Metal Technology
Orthopedic · 74d
Cleared May 25, 2010
PROPHECY PRE-OPERATIVE NAVIGATION ALIGNMENT GUIDES
K093405
Wrightmedicaltechnologyinc
Orthopedic · 204d
Cleared May 13, 2010
LEGION POROUS + HA TIBIAL BASEPLATES
K100897
Smith & Nephew, Inc.
Orthopedic · 43d
Cleared Feb 17, 2010
ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM, VERSION 2.0
K093533
Materialise NV
Orthopedic · 93d
Cleared Dec 21, 2009
LEGION POROUS PLUS HA PRIMARY FEMORAL COMPONENTS
K091543
Smith & Nephew, Inc.
Orthopedic · 209d
Cleared Apr 03, 2009
REGENEREX PATELLA COMPONENTS
K083782
Biomet Manufacturing Corp
Orthopedic · 105d
Cleared Feb 20, 2009
ADVANCE A-CLASS TIBIAL INSERT
K081479
Wrightmedicaltechnologyinc
Orthopedic · 269d
Cleared May 23, 2008
APEX KNEE SYSTEM, MODEL KC-230XY, KC-240XY [ NO HOLES, 2 HOLES]
K080842
Omni Life Science, Inc.
Orthopedic · 59d
Cleared Apr 21, 2008
REGENEREX TIBIAL COMPONENTS
K080361
Biomet, Inc.
Orthopedic · 70d
Cleared Jan 07, 2008
TRIATHLON SCREW-FIXATION TIBIAL BASEPLATE
K072575
Stryker Orthopaedics
Orthopedic · 116d
Cleared Dec 20, 2007
LEGION POROUS PRIMARY
K073325
Smith & Nephew, Inc.
Orthopedic · 23d
Cleared Nov 21, 2007
NEXGEN COMPLETE KNEE SOLUTION LPS-FLEX AND KNEE GENDER SOLUTIONS FEMALE (GSF) POROUS FEMORAL COMPONENTS
K072619
Zimmer, Inc.
Orthopedic · 65d
Cleared Sep 05, 2007
NEXGEN TRABECULAR METAL TIBIAL TRAY
K072160
Zimmer, Inc.
Orthopedic · 30d
Cleared Aug 17, 2007
GENESIS II TOTAL KNEE SYSTEM, LEGION REVISION KNEE SYSTEM, JOURNEY BCS KNEE SYSTEM
K071790
Smith & Nephew, Inc.
Orthopedic · 46d
Cleared Aug 02, 2007
DEPUY LPS DIAPHYSEAL AND METAPHYSEAL SLEEVES
K071417
DePuy Orthopaedics, Inc.
Orthopedic · 73d
Cleared Jul 06, 2007
GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM
K071107
Zimmer, Inc.
Orthopedic · 78d
Cleared May 11, 2007
DURACON X3 CS TIBIAL INSERT
K070883
Howmedica Osteonics Corp.
Orthopedic · 42d
Cleared Mar 21, 2007
ADVANCE SPIKED POROUS TIBIAL BASE
K063128
Wrightmedicaltechnologyinc
Orthopedic · 159d
Cleared Mar 16, 2007
GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM
K070214
Zimmer, Inc.
Orthopedic · 52d
Cleared Mar 02, 2007
ADVANCE STATURE FEMORAL COMPONENT
K063731
Wrightmedicaltechnologyinc
Orthopedic · 74d
Cleared Sep 29, 2006
DEPUY SIGMA CRUCIATE RETAINING POROCOAT FEMORAL COMPONENTS
K062654
DePuy Orthopaedics, Inc.
Orthopedic · 22d