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
73–96 of 144
Cleared Oct 27, 2014
VANGUARD XP FEMORAL COMPONENT(GEN II)/VANGUARD XP FEMORAL TRIAL
K141407
Biomet, Inc.
Orthopedic · 152d
Cleared Sep 03, 2014
ARTHREX IBALANCE TKA SYSTEM
K141635
Arthrex, Inc.
Orthopedic · 76d
Cleared Sep 03, 2014
TRABECULAR METAL TIBIAL CONE BROACH, TRABECULAR METAL COUPLED TIBIAL CONE BROACH
K141840
Zimmer, Inc.
Orthopedic · 57d
Cleared Aug 29, 2014
EVOLUTION MP CS/CR POROUS FEMUR/EVOLUTION ADAPTIVE CS AND PS INSERTS
K140735
Microport Orthopedics, Inc.
Orthopedic · 158d
Cleared Aug 05, 2014
TRIATHLON KNEE SYSTEM POSTERIOR STABILIZED COMPONENTS
K141056
Stryker Orthopaedics
Orthopedic · 103d
Cleared Jul 30, 2014
OPTETRAK LOGIC POROUS FEMORAL COMPONENTS
K140302
Exactech, Inc.
Orthopedic · 174d
Cleared Jul 30, 2014
VANGUARD 360 OSSEOTI TIBIAL SLEEVE AUGMENT
K140883
Biomet, Inc.
Orthopedic · 114d
Cleared Jun 13, 2014
U2 FEMORAL COMPONENT, CR, POROUS COATED
K140075
United Orthopedic Corp.
Orthopedic · 151d
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 Nov 26, 2013
TRIATHLON TRITANIUM METAL-BACKED PATELLA
K132624
Stryker Orthopaedics
Orthopedic · 96d
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 Jun 29, 2012
NEXGEN LCCK TRABECULAR METAL (TM) COUPLED TIBIAL CONES PROVISIONALS TO NEXGEN LCCK TRABECULAR METAL (TM) COUPLED TIBIAL
K120990
Zimmer Trabecular Metal Technology
Orthopedic · 88d
Cleared Oct 17, 2011
PROPHECY PRE-OPERATIVE NAVIGATION ALIGNMENT GUIDES
K103598
Wrightmedicaltechnologyinc
Orthopedic · 313d
Cleared Jun 27, 2011
CONSENSUS KNEE SYSTEM
K110950
Consensus Orthopedics, Inc.
Orthopedic · 84d
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