Medical device licence · 61084 · Class 3
DURACON TOTAL KNEE SYSTEM
No longer licensed: merged into another licence
Licence status Merged into another licence; first licensed November 28, 2002; ended January 25, 2005. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 61084
- Licence holder
- Howmedica Osteonics CorporationMahwah, NJ, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- November 28, 2002
- Ended
- January 25, 2005
- Devices covered
- 13
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 ASYMMETRIC PATELLA - METAL
- DURACON TOTAL KNEE CONDYLAR TIBIAL INSERTS
- DURACON TOTAL KNEE INSET PATELLA - ALL-POLY
- DURACON TOTAL KNEE SYMMETRIC PATELLA - ALL-POLY
- DURACON TOTAL KNEE SYSTEM - CONSTRAINED PS TIBIAL BEARING INSERTS
- DURACON TOTAL KNEE SYSTEM - PCA REVIEW - TIBIAL INSERT
- 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
- DURACON TOTAL KNEE SYSTEM - TIBIAL INSERT CONSTRAINED
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.
- Scorpio and Duracon Total Knee SystemsDecember 21, 2023 · Orthopaedics · Performance · Type II
- DURACON TOTAL KNEE SYSTEM - HEMI,FLAT, TIBIAL AUGMENTS(2015-09-22)October 8, 2015 · Medical devices · Health products · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.