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..

143
Total
143
Cleared
119d
Avg days
2003
Since
143 devices
73–96 of 143
Cleared Apr 02, 2014
SIGNATURE PLANNER, SIGNATURE GUIDES
K140257
Materialise NV
Orthopedic · 58d
Cleared Dec 11, 2013
VANGUARD XP KNEE SYSTEM
K132873
Biomet, Inc.
Orthopedic · 89d
Cleared May 03, 2013
TRIATHLON TRITANIUM TIBIAL BASEPLATE
K123486
Stryker
Orthopedic · 171d
Cleared Mar 21, 2013
ADVANCE TOTAL KNEE SYSTEM-PATELLA
K122218
Wrightmedicaltechnologyinc
Orthopedic · 239d
Cleared Mar 20, 2013
VANGUARD XP KNEE SYSTEM
K122160
Biomet Manufacturing Corp
Orthopedic · 243d
Cleared Feb 22, 2013
ZIMMER PERSONA TM PERSONALIZED KNEE SYSTEM
K123459
Zimmer, Inc.
Orthopedic · 105d
Cleared Dec 05, 2012
ZIMMER PERSONA THE PERSONALIZED KNEE SYSTEM
K122745
Zimmer, Inc.
Orthopedic · 89d
Cleared Nov 07, 2012
ZIMMER PERSONA THE PERSONALIZED KNEE SYSTEM
K121771
Zimmer, Inc.
Orthopedic · 145d
Cleared Oct 24, 2012
SHAPEMATCH CUTTING GUIDE
K122053
Stryker Corp.
Orthopedic · 103d
Cleared Aug 07, 2012
SMITH & NEPHEW, INC. TOTAL KNEE SYSTEM INSTRUMENTATION
K121393
Smith & Nephew, Inc.
Orthopedic · 90d
Cleared Oct 17, 2011
PROPHECY PRE-OPERATIVE NAVIGATION ALIGNMENT GUIDES
K103598
Wrightmedicaltechnologyinc
Orthopedic · 313d
Cleared May 19, 2011
STRYKER PATIENT SPECIFIC CUTTING GUIDE
K110533
Stryker Corp.
Orthopedic · 84d
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 Apr 21, 2008
REGENEREX TIBIAL COMPONENTS
K080361
Biomet, Inc.
Orthopedic · 70d
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