Product code MBV— Orthopedic

FDA has cleared 14 devices under product code MBV between 1978 and 2001, filed by 6 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20011 clearance
• 19891 clearance
• 19871 clearance
• 19861 clearance
• 19836 clearances
• 19821 clearance
• 19811 clearance
• 19782 clearances

• Depuy, Inc.5 clearances
• Richards Medical Co., Inc.2 clearances
• Richard'S Medical Equip., Inc.2 clearances
• Protek, Inc.2 clearances
• Advanced Biosearch Assn.2 clearances
• Biomet, Inc.1 clearance

• K010212 — OFFSET TIBIAL TRAYBiomet, Inc.·2001-02-14
• K884824 — TRICON-M TOTAL KNEE SYSTEMRichards Medical Co., Inc.·1989-11-21
• K873429 — FREEMAN-SAMUELSON MARK II PRESS-FIT TOTAL KNEEProtek, Inc.·1987-10-28
• K853730 — FREEMAN-SAMUELSON MARK II PRESS-FIT TOTAL KNEE REPProtek, Inc.·1986-02-18
• K833200 — TRICON M TOTAL KNEE SYSTEMRichards Medical Co., Inc.·1983-11-29
• K831441 — POROCOAT FREEMAN/SAMUELSON TOTAL KNEEDepuy, Inc.·1983-09-01
• K832302 — MARK I TOTAL KNEE SYS. ARTHROPLASTYAdvanced Biosearch Assn.·1983-08-16
• K830726 — MARK I & II TOTAL KNEE REPLACE. SYSAdvanced Biosearch Assn.·1983-06-22
• K823837 — RMC TOTAL KNEE SYSTEMRichard'S Medical Equip., Inc.·1983-03-29
• K830408 — FREEMAN/SAMUELSON TOTAL KNEEDepuy, Inc.·1983-02-24
• K822583 — TOTAL KNEE SYSTEMRichard'S Medical Equip., Inc.·1982-10-04
• K802921 — ICLH TIBIAL PLATEAUDepuy, Inc.·1981-01-08
• K780904 — KNEE, TOTAL, FEMORAL & TIBIALDepuy, Inc.·1978-06-22
• K780284 — TIBIAL PLATEUDepuy, Inc.·1978-03-15