Medical device licence · 983 · Class 3
GENESIS II TOTAL KNEE SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed February 4, 1999. It is in Health Canada’s list of active licences.
- Licence number
- 983
- Licence holder
- Smith & Nephew, Inc.Mississauga, Ontario, Canada
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- February 4, 1999
- Devices covered
- 72
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- GENESIS II ALL POLY CRUCIATE RETAINING TIBIAL BASE
- GENESIS II ALL POLY PATELLAR COMPONENT WITH FLEX-LOK
- GENESIS II ALL POLY POSTERIOR STABILIZED TIBIAL BASE
- GENESIS II BICONVEX PATELLAR COMPONENT
- GENESIS II BICONVEX PATELLAR COMPONENT TRIAL
- GENESIS II CONSTRAINED ARTICULAR INSERT
- GENESIS II CONSTRAINED ARTICULAR INSERT TRIAL
- GENESIS II CONSTRAINED ARTICULAR INSERT WITH JOURNEY LOCK DETAIL
- GENESIS II CONTRAINED ARTICULAR INSERT TRIAL WITH JOURNEY LOCK DETAIL
- GENESIS II CR DEEP FLEXION ARTICULAR INSERT
- GENESIS II CRUCIATE RETAINING ARTICULAR INSERT
- GENESIS II CRUCIATE RETAINING ARTICULAR INSERT TRIAL
- GENESIS II CRUCIATE RETAINING DEEP FLEXION ARTICULAR INSERT TRIAL
- GENESIS II CRUCIATE RETAINING OXINIUM FEMORAL COMPONENT
- GENESIS II DISHED ARTICULAR INSERT
- GENESIS II DISHED ARTICULAR INSERT TRIAL
- GENESIS II DISHED ARTICULAR INSERT TRIAL
- GENESIS II FEMORAL DRILL
- GENESIS II FEMORAL FLEX-LOK PEG
- GENESIS II FEMORAL LUG TRIAL
- GENESIS II KNEE SYSTEM - INSTRUMENTATION
- GENESIS II KNEE SYSTEM - NON-POR REVISION TIBIAL PLATE
- GENESIS II LONG STEM REAMER
- GENESIS II LONG STEM TRIAL
- GENESIS II LONG STEM, NON-SLOTTED
- GENESIS II LONG STEM, SLOTTED
- GENESIS II NON-POROUS CRUCIATE RETAINING FEMORAL COMPONENT
- GENESIS II NON-POROUS CRUCIATE RETAINING FEMORAL COMPONENT TRIAL
- GENESIS II NON-POROUS POSTERIOR STABILIZED FEMORAL COMPONENT
- GENESIS II NON-POROUS TIBIAL BASE
- GENESIS II NON-POROUS TIBIAL BASE TRIAL
- GENESIS II OVAL RESURFACING PATELLAR COMPONENT
- GENESIS II OVAL RESURFACING PATELLAR COMPONENT TRIAL
- GENESIS II OVAL RESURFACING PATELLAR DRILL GUIDE
- GENESIS II OVAL RESURFACING PATELLAR PEG DRILL
- GENESIS II P/S HOUSING RESECTION BLOCK
- GENESIS II PATELLAR COMPONENT WITH FLEX-LOK PEG TRIAL
- GENESIS II PATELLAR REAMER SHAFT
- GENESIS II POROUS CRUCIATE RETAINING FEMORAL COMPONENT
- GENESIS II POROUS POSTERIOR STABILIZED FEMORAL COMPONENT
- GENESIS II POROUS TIBIAL COMPONENT TRIAL
- GENESIS II POSTERIOR STABILIZED ARTICULAR INSERT
- GENESIS II POSTERIOR STABILIZED ARTICULAR INSERT TRIAL
- GENESIS II POSTERIOR STABILIZED FEMORAL COMPONENT TRIAL
- GENESIS II POSTERIOR STABILIZED HIGH FLEXION ARTICULAR INSERT TRIAL
- GENESIS II POSTERIOR STABILIZED HIGH FLEXION ARTICULAR INSERT TRIAL WITH JOURNEY LOCK DETAIL
- GENESIS II POSTERIOR STABILIZED OXINIUM FEMORAL COMPONENT
- GENESIS II PS HIGH FLEXION ARTICULAR INSERT
- GENESIS II PS HIGH FLEXION ARTICULAR INSERT WITH JOURNEY LOCK DETAIL
- GENESIS II RESURFACING PATELLA
- GENESIS II RESURFACING PATELLAR COMPONENT TRIAL
- GENESIS II RESURFACING PATELLAR DRILL
- GENESIS II RESURFACING PATELLAR REAMER
- GENESIS II REVISION BICONVEX PATELLAR COMPONENT
- GENESIS II REVISION BICONVEX PATELLAR COMPONENT TRIAL
- GENESIS II SCREW-ON HEMI STEPPED TIBIAL WEDGE TRIAL
- GENESIS II SPC CONSTRAINED ARTICULAR INSERT TRIAL
- GENESIS II SPC POSTERIOR STABILIZED CAM MODULE
- GENESIS II SPC REAM THROUGH CRUCIATE RETAINING FEMORAL COMPONENT TRIAL
- GENESIS II STEMLESS TIBIAL COMPONENT TRIAL
- GENESIS II STEPPED HEMI TIBIAL WEDGE
- GENESIS II STRYKER SAWBLADE
- GENESIS II TIBIAL BASE WITH GROOVES
- GENESIS II TIBIAL BONE SCREW
- GENESIS II TIBIAL DRILL
- GENESIS II TIBIAL OFFSET COUPLER WITH SLEEVE
- REVISION PRESS FIT NON-SLOTTED STEM
- REVISION PRESS FIT SLOTTED STEM
- SCREW-ON FULL STEP, TIBIAL WEDGE TRIAL
- SCREW-ON FULL STEPPED TIBIAL WEDGE
- SCREW-ON HEMI STEPPED TIBIAL WEDGE
- TIBIAL WEDGE SCREW
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.