Medical device licence · 101712 · Class 3

ATTUNE REVISION KNEE SYSTEM

Yes: licensed in Canada

Licence status Issued (active); first licensed September 11, 2018. It is in Health Canada’s list of active licences.

Licence number: 101712
Licence holder: Depuy Ireland UcRingaskiddy, CK, Ireland
Risk class: Class III (moderate to high risk)
Licence type: System
First licensed: September 11, 2018
Devices covered: 130

Devices on this licence

By name, as listed. The official record lists model numbers and identifiers.

ATTUNE KNEE SYSTEM REVISION CONE CONCENTRIC
ATTUNE KNEE SYSTEM REVISION CONE CONCENTRIC TRIAL
ATTUNE KNEE SYSTEM REVISION CONE FEMORAL
ATTUNE KNEE SYSTEM REVISION CONE FEMORAL TRIAL
ATTUNE KNEE SYSTEM REVISION CONE REAMER
ATTUNE KNEE SYSTEM REVISION CONE TIBIAL BI-LOBE TRIAL
ATTUNE KNEE SYSTEM REVISION CONE TIBIAL BILOBE
ATTUNE KNEE SYSTEM REVISION CONE TIBIAL KEEL TRIAL
ATTUNE KNEE SYSTEM REVISION CONE TIBIAL TRI-LOBE TRIAL
ATTUNE KNEE SYSTEM REVISION CONE TIBIAL TRILOBE
ATTUNE KNEE SYSTEM REVISION CONE TRIAL EXTRACTOR
ATTUNE KNEE SYSTEM REVISION FEMORAL TEMPLATE
ATTUNE KNEE SYSTEM REVISION HINGE BASE TRIAL ADAPTOR
ATTUNE KNEE SYSTEM REVISION HINGE FEMORAL
ATTUNE KNEE SYSTEM REVISION HINGE FEMORAL SHIM
ATTUNE KNEE SYSTEM REVISION HINGE FEMORAL TRIAL
ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN
ATTUNE KNEE SYSTEM REVISION HINGE HOUSING SPARE CROSSPIN
ATTUNE KNEE SYSTEM REVISION HINGE INSERT
ATTUNE KNEE SYSTEM REVISION HINGE INSERT TRIAL
ATTUNE KNEE SYSTEM REVISION HINGE PIN EXTRACTOR
ATTUNE KNEE SYSTEM REVISION HINGE RP TRIAL IMPLANT POST
ATTUNE KNEE SYSTEM REVISION RP THICK BASE TRIAL
ATTUNE KNEE SYSTEM REVISION RP THICK BASE TRIAL ADAPTOR
ATTUNE KNEE SYSTEM REVISION THICK TIBIAL SLEEVE SEPARATOR WEDGE
ATTUNE REVISION ANTERIOR CUT BLOCK
ATTUNE REVISION ASSEMBLY BASE
ATTUNE REVISION ASSEMBLY FEMORAL IMPLANT POST
ATTUNE REVISION ASSEMBLY FEMORAL SHIM
ATTUNE REVISION ASSEMBLY FEMORAL TRIAL POST
ATTUNE REVISION ASSEMBLY OFFSET STABILIZER
ATTUNE REVISION AUGMENT WOBBLE BIT
ATTUNE REVISION BASE MOUNT
ATTUNE REVISION BOSS ADAPTOR TRIAL
ATTUNE REVISION BOSS AND STEM ADAPTOR TRIAL EXTRACTOR
ATTUNE REVISION BOSS REAMER
ATTUNE REVISION BOX CUT PLATFORM
ATTUNE REVISION BROACH ADAPTOR
ATTUNE REVISION BROACH MOUNT
ATTUNE REVISION BROACH STOP SHIM
ATTUNE REVISION CANAL REAMER
ATTUNE REVISION CEMENTED FEMORAL STEM REAMER
ATTUNE REVISION CEMENTED STEM TRIAL
ATTUNE REVISION CEMENTED STEMS
ATTUNE REVISION CONVENTIONAL CUT GUIDE
ATTUNE REVISION CONVENTIONAL CUT GUIDE REAMER GUIDE
ATTUNE REVISION CRS FEMORAL COMPONENTS
ATTUNE REVISION CRS FIXED BEARING INSERT
ATTUNE REVISION CRS ROTATING PLATFORM INSERT
ATTUNE REVISION DISTAL FEMORAL AUGMENT TRIAL
ATTUNE REVISION DISTAL FEMORAL AUGMENTS
ATTUNE REVISION DISTALIZING GAUGE
ATTUNE REVISION FB ADAPTOR TRIAL
ATTUNE REVISION FB BASE TRIAL
ATTUNE REVISION FB CONICAL REAMER
ATTUNE REVISION FB INSERT TRIAL
ATTUNE REVISION FB STEM ADAPTOR TRIAL
ATTUNE REVISION FE GUIDE
ATTUNE REVISION FE POSTERIOR STABILIZING SPACER
ATTUNE REVISION FEMORAL BOX TRIAL
ATTUNE REVISION FEMORAL BROACH STARTER REAMER
ATTUNE REVISION FEMORAL BROACH STOP
ATTUNE REVISION FEMORAL BROACH TRIAL BOLT
ATTUNE REVISION FEMORAL CTT TRIAL
ATTUNE REVISION FEMORAL IM ADAPTOR
ATTUNE REVISION FEMORAL IM CONNECTOR
ATTUNE REVISION FEMORAL OFFSET ADAPTOR TRIAL
ATTUNE REVISION FEMORAL OFFSET DIAL
ATTUNE REVISION FEMORAL OFFSET GUIDE
ATTUNE REVISION FEMORAL POSITIONER
ATTUNE REVISION FEMORAL REAMER BUSHING
ATTUNE REVISION FEMORAL REAMER REFERENCE TOOL
ATTUNE REVISION FEMORAL SLEEVE SEPARATOR PUSH ROD
ATTUNE REVISION FEMORAL SLEEVE TAPER SEPARATOR BASE
ATTUNE REVISION FEMORAL SLEEVE TAPER SEPARATOR DRIVER
ATTUNE REVISION FEMORAL SLEEVES
ATTUNE REVISION FEMORAL SOLID TRIAL
ATTUNE REVISION FEMORAL STEM TRIAL BOLT
ATTUNE REVISION FEMORAL TRIAL EXTRACTOR
ATTUNE REVISION FEMORAL TRIAL REAMER GUIDE
ATTUNE REVISION GUIDE DISTAL SPACER
ATTUNE REVISION IM MOUNT
ATTUNE REVISION LPS INSERT AOX
ATTUNE REVISION LPS INSERT BASE TRIAL ADAPTER
ATTUNE REVISION LPS INSERT TRIAL
ATTUNE REVISION LPS INSERT TRIAL POST
ATTUNE REVISION MODULAR STOP
ATTUNE REVISION NOTCH CUT GUIDE
ATTUNE REVISION OFFSET DRILL
ATTUNE REVISION OFFSET REAMER REFERENCE TOOL
ATTUNE REVISION OFFSET STEM ADAPTORS
ATTUNE REVISION POSTERIOR CAPTURE
ATTUNE REVISION POSTERIOR FEMORAL AUGMENT TRIAL
ATTUNE REVISION POSTERIOR FEMORAL AUGMENTS
ATTUNE REVISION PRESS-FIT STEM TRIAL
ATTUNE REVISION PRESSFIT STEMS
ATTUNE REVISION RP BASE TRIAL
ATTUNE REVISION RP CONICAL REAMER
ATTUNE REVISION RP INSERT TRIAL
ATTUNE REVISION RP STEM ADAPTOR TRIAL
ATTUNE REVISION SLAP HAMMER ADAPTOR - IMPLANT
ATTUNE REVISION SLEEVE LIMB PRESERVATION SYSTEM FEMORAL ADAPTOR
ATTUNE REVISION SLEEVE LIMB PRESERVATION SYSTEM FEMORAL ADAPTOR TRIAL
ATTUNE REVISION SPACER BLOCK SHIM
ATTUNE REVISION STEM TRIAL AND STABILIZER EXTRACTOR
ATTUNE REVISION STEM TRIAL DRIVER BIT
ATTUNE REVISION SYSTEM HEX ATTACHMENT
ATTUNE REVISION TAPER SEPARATOR ROD
ATTUNE REVISION THICK TIBIAL BASE ROTATING PLATFORM
ATTUNE REVISION TIBIAL AUGMENT
ATTUNE REVISION TIBIAL AUGMENT TRIAL
ATTUNE REVISION TIBIAL BASE FIXED BEARING
ATTUNE REVISION TIBIAL BASE ROTATING PLATFORM
ATTUNE REVISION TIBIAL BASE TRIAL EXTRACTOR
ATTUNE REVISION TIBIAL CEMENTED CONICAL REAMER
ATTUNE REVISION TIBIAL CEMENTED REAMER BUSHING
ATTUNE REVISION TIBIAL CUT BLOCK MOUNT
ATTUNE REVISION TIBIAL CUTTING BLOCK
ATTUNE REVISION TIBIAL OFFSET ADAPTOR TRIAL
ATTUNE REVISION TIBIAL OFFSET GUIDE
ATTUNE REVISION TIBIAL PREP PLATE
ATTUNE REVISION TIBIAL PREP TOWER
ATTUNE REVISION TIBIAL PREP TOWER OFFSET BUSHING
ATTUNE REVISION TIBIAL REAMER REFERENCE TOOL
ATTUNE REVISION TIBIAL SLEEVE SEPARATOR - ATTUNE SLEEVE WEDGE
ATTUNE REVISION TIBIAL SLEEVE SEPARATOR - BASE ATTACHMENT
ATTUNE REVISION TIBIAL SLEEVE SEPARATOR - DRIVER
ATTUNE REVISION TIBIAL SLEEVE TRIAL
ATTUNE REVISION TIBIAL SLEEVES
KINCISE ATTUNE REVISION BROACH ADAPTER

Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.