ApprovalTrail

Medical device licence · 60534 · Class 3

DURACON TOTAL KNEE SYSTEM

Yes: licensed in Canada

Licence status Issued (active); first licensed September 26, 2002. It is in Health Canada’s list of active licences.
Licence number
60534
Licence holder
Howmedica Osteonics CorporationMahwah, NJ, United States
Risk class
Class III (moderate to high risk)
Licence type
System
First licensed
September 26, 2002
Devices covered
18

Devices on this licence

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

  • DURACON TOTAL KNEE A/P LIPPED TIBIAL INSERTS
  • DURACON TOTAL KNEE ASYMMETRIC PATELLA - ALL-POLY
  • DURACON TOTAL KNEE INSET PATELLA - ALL-POLY
  • DURACON TOTAL KNEE SML A/P LIPPED TRIAL INSERT
  • DURACON TOTAL KNEE SYMMETRIC PATELLA - ALL-POLY
  • DURACON TOTAL KNEE SYSTEM - FLAT TIBIAL WEDGE AUGMENTS
  • DURACON TOTAL KNEE SYSTEM - FLUTED STEM
  • DURACON TOTAL KNEE SYSTEM - HEMI,FLAT, TIABIAL AUGMENTS
  • DURACON TOTAL KNEE SYSTEM - OFFSET STEM
  • DURACON TOTAL KNEE SYSTEM - PCA REVIEW - TIBIAL INSERT
  • DURACON TOTAL KNEE SYSTEM - PRESSFIT TIBIAL STEM
  • DURACON TOTAL KNEE SYSTEM - PS LIPPED TB INSERTS
  • DURACON TOTAL KNEE SYSTEM - REVISION TIBIAL INSERT - MOD REV/DUR REV
  • DURACON TOTAL KNEE SYSTEM - STABILIZED TIBIAL INSERT
  • DURACON TOTAL KNEE SYSTEM - TIBIAL INSERT CONSTRAINED
  • DURACON TROL SPCR FULL
  • MONOGRAM KNEE DURACON FULL FLAT TIBIAL WEDGE TRIAL
  • SPECIALTY DURACON INSET PATELLA REAMING CUTTER

Recalls and safety alerts that mention it

Health Canada’s recall notices do not carry licence numbers, so these are matched by name: notices whose title or product names “duracon”. A notice may cover another product or only some lots: read it to see what it covers.

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