ApprovalTrail

Medical device licence · 86718 · Class 3

FOUNDATION KNEE SYSTEM - REVISION

No longer licensed: discontinued at renewal

Licence status Discontinued at renewal; first licensed July 22, 2011; ended November 23, 2018. It is in Health Canada’s archive of licences no longer in force.
Licence number
86718
Licence holder
Encore Medical, L.P.Austin, TX, United States
Risk class
Class III (moderate to high risk)
Licence type
System
First licensed
July 22, 2011
Ended
November 23, 2018
Devices covered
32

Devices on this licence

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

  • FOUNDATION KNEE SYSTEM - CONSTRAINED PS INSERT 11MM
  • FOUNDATION KNEE SYSTEM - CONSTRAINED PS INSERT 11MM CM
  • FOUNDATION KNEE SYSTEM - CONSTRAINED PS INSERT 13MM
  • FOUNDATION KNEE SYSTEM - CONSTRAINED PS INSERT 13MM CM
  • FOUNDATION KNEE SYSTEM - CONSTRAINED PS INSERT 15MM
  • FOUNDATION KNEE SYSTEM - CONSTRAINED PS INSERT 15MM CM
  • FOUNDATION KNEE SYSTEM - CONSTRAINED PS INSERT 17MM
  • FOUNDATION KNEE SYSTEM - CONSTRAINED PS INSERT 17MM CM
  • FOUNDATION KNEE SYSTEM - CONSTRAINED PS INSERT 19MM
  • FOUNDATION KNEE SYSTEM - CONSTRAINED PS INSERT 19MM CM
  • FOUNDATION KNEE SYSTEM - CONSTRAINED PS INSERT 22MM
  • FOUNDATION KNEE SYSTEM - CONSTRAINED PS INSERT 22MM CM
  • FOUNDATION KNEE SYSTEM - CONSTRAINED PS INSERT 25MM
  • FOUNDATION KNEE SYSTEM - CONSTRAINED PS INSERT 25MM CM
  • FOUNDATION KNEE SYSTEM - DISTAL FEMORAL SPACER BLOCK, RIGHT LATERAL, LEFT MEDIAL, 10MM
  • FOUNDATION KNEE SYSTEM - DISTAL FEMORAL SPACER BLOCK, RIGHT LATERAL, LEFT MEDIAL, 5MM
  • FOUNDATION KNEE SYSTEM - METAL STEM SIZE 100MM
  • FOUNDATION KNEE SYSTEM - METAL STEM SIZE 150MM
  • FOUNDATION KNEE SYSTEM - NON-POROUS MODULAR REV STEMMED TIBIA LEFT
  • FOUNDATION KNEE SYSTEM - NON-POROUS MODULAR REV STEMMED TIBIA RIGHT
  • FOUNDATION KNEE SYSTEM - NON-POROUS PS-REVISION FEMUR LEFT
  • FOUNDATION KNEE SYSTEM - NON-POROUS PS-REVISION FEMUR RIGHT
  • FOUNDATION KNEE SYSTEM - TIBIAL STEM SIZE 100MM
  • FOUNDATION KNEE SYSTEM - TIBIAL STEM SIZE 150MM
  • FOUNDATION KNEE SYSTEM -DISTAL FEMORAL SPACER BLOCK, LEFT LATERAL, RIGHT MEDIAL, 5MM
  • FOUNDATION KNEE SYSTEM-DISTAL FEMORAL SPACER BLOCK, LEFT LATERAL, RIGHT MEDIAL, 10MM
  • FOUNDATION KNEE SYSTEM-POSTERIOR FEMORAL SPACER BLOCK 10MM
  • FOUNDATION KNEE SYSTEM-POSTERIOR FEMORAL SPACER BLOCK 5MM
  • FOUNDATION KNEE SYSTEM-TIBIAL SPACER BLOCK LEFT LATERAL RIGHT MEDIAL 10MM
  • FOUNDATION KNEE SYSTEM-TIBIAL SPACER BLOCK LEFT LATERAL RIGHT MEDIAL 5MM
  • FOUNDATION KNEE SYSTEM-TIBIAL SPACER BLOCK RIGHT LATERAL LEFT MEDIAL 10MM
  • FOUNDATION KNEE SYSTEM-TIBIAL SPACER BLOCK RIGHT LATERAL LEFT MEDIAL 5MM

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