ApprovalTrail

Medical device licence · 83247 · Class 3

GMK PRIMARY TOTAL KNEE SYSTEM

Yes: licensed in Canada

Licence status Issued (active); first licensed July 5, 2010. It is in Health Canada’s list of active licences.
Licence number
83247
Licence holder
Medacta International SaCastel San Pietro, Switzerland
Risk class
Class III (moderate to high risk)
Licence type
System
First licensed
July 5, 2010
Devices covered
16

Devices on this licence

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

  • GMK PRIMARY TOTAL KNEE SYSTEM - CEMENTED FIXED TIBIAL TRAY
  • GMK PRIMARY TOTAL KNEE SYSTEM - CEMENTED MOBILE TIBIAL TRAY
  • GMK PRIMARY TOTAL KNEE SYSTEM - CEMENTED POSTERO-STABILIZED FEMURS
  • GMK PRIMARY TOTAL KNEE SYSTEM - CEMENTED STANDARD FEMURS
  • GMK PRIMARY TOTAL KNEE SYSTEM - CEMENTLESS FIXED TIBIAL TRAY
  • GMK PRIMARY TOTAL KNEE SYSTEM - CEMENTLESS MOBILE TIBIAL TRAY
  • GMK PRIMARY TOTAL KNEE SYSTEM - CEMENTLESS POSTERO-STABILIZED FEMURS
  • GMK PRIMARY TOTAL KNEE SYSTEM - CEMENTLESS STANDARD FEMURS
  • GMK PRIMARY TOTAL KNEE SYSTEM - EXTENSION STEM
  • GMK PRIMARY TOTAL KNEE SYSTEM - INSET PATELLA
  • GMK PRIMARY TOTAL KNEE SYSTEM - POSTERO-STABILIZED FIXED TIBIAL INSERT
  • GMK PRIMARY TOTAL KNEE SYSTEM - RESURFACING PATELLA
  • GMK PRIMARY TOTAL KNEE SYSTEM - STANDARD FIXED TIBIAL INSERT
  • GMK PRIMARY TOTAL KNEE SYSTEM - STANDARD MOBILE TIBIAL INSERT
  • GMK PRIMARY TOTAL KNEE SYSTEM - ULTRA CONGRUENT FIXED TIBIAL INSERT
  • GMK PRIMARY TOTAL KNEE SYSTEM - ULTRA CONGRUENT MOBILE TIBIAL INSERT

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