Medical device licence · 10580 · Class 3
DURACON TOTAL KNEE SYSTEM
No longer licensed: discontinued at renewal
Licence status Discontinued at renewal; first licensed August 26, 1999; ended November 26, 2003. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 10580
- Licence holder
- Howmedica Osteonics CorporationMahwah, NJ, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- August 26, 1999
- Ended
- November 26, 2003
- Devices covered
- 42
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- DURACON PS LIPPED TB INSERTS - LARGE
- DURACON PS LIPPED TB INSERTS - MEDIUM
- DURACON PS LIPPED TB INSERTS - SMALL
- DURACON PS LIPPED TB INSERTS - XLARGE
- DURACON TOTAL KNEE SYSTEM - STABILIZER FEMORAL COMPONENT
- DURACON TOTAL KNEE SYSTEM - A/P LIPPED TIBIAL INSERT
- DURACON TOTAL KNEE SYSTEM - ALL PLASTIC TIBIAL COMPONENT
- DURACON TOTAL KNEE SYSTEM - CONSTRAINED PS TIBIAL BEARING INSERTS
- DURACON TOTAL KNEE SYSTEM - CRUCIFORM TIBIAL BASEPLATE
- DURACON TOTAL KNEE SYSTEM - CRUCIFORM TIBIAL BASEPLATE - POROUS
- DURACON TOTAL KNEE SYSTEM - DISTAL FEMORAL LOCKING SCREW
- DURACON TOTAL KNEE SYSTEM - DISTAL FEMORAL SPACER 5MM&10MM(MEDIAL&LATERAL)
- DURACON TOTAL KNEE SYSTEM - FEMORAL BEADED
- DURACON TOTAL KNEE SYSTEM - FEMORAL NON-BEADED
- DURACON TOTAL KNEE SYSTEM - FEMORAL PEG
- DURACON TOTAL KNEE SYSTEM - FLAT TIBIAL WEDGE
- DURACON TOTAL KNEE SYSTEM - FLAT TIBIAL WEDGE AUGMENTS
- DURACON TOTAL KNEE SYSTEM - FLUTED STEM
- DURACON TOTAL KNEE SYSTEM - FULL FEMORAL SPACER 5MM & 10MM
- DURACON TOTAL KNEE SYSTEM - HALF POSTERIOR FEMORAL SPACER
- DURACON TOTAL KNEE SYSTEM - INSET PATELLA
- DURACON TOTAL KNEE SYSTEM - MODULAR FEMORAL COMPONENT (POROUS & NON-POROUS)
- DURACON TOTAL KNEE SYSTEM - MONOLITHIC STABILIZER FEMORAL COMPONENT
- DURACON TOTAL KNEE SYSTEM - OFFSET STEM ADAPTER
- DURACON TOTAL KNEE SYSTEM - PATELLA METAL BACKED
- DURACON TOTAL KNEE SYSTEM - PATELLA PLASTIC
- DURACON TOTAL KNEE SYSTEM - POSTERIOR FEMORAL SPACER
- DURACON TOTAL KNEE SYSTEM - PRESS FIT STEMS
- DURACON TOTAL KNEE SYSTEM - REVISION TIBIAL INSERT
- DURACON TOTAL KNEE SYSTEM - STABILIZER BOX
- DURACON TOTAL KNEE SYSTEM - STABILIZER TIBIAL INSERT
- DURACON TOTAL KNEE SYSTEM - STABILIZER TIBIAL INSERT ASSEMBLY W/SCREW
- DURACON TOTAL KNEE SYSTEM - STEMMED STABILIZER FEMORAL COMPONENT
- DURACON TOTAL KNEE SYSTEM - SYMMETRIC PATELLA
- DURACON TOTAL KNEE SYSTEM - TIBIAL INSERT
- DURACON TOTAL KNEE SYSTEM - TIBIAL INSERT CONSTRAINED
- DURACON TOTAL KNEE SYSTEM - TIBIAL WEDGE
- DURACON TOTAL KNEE SYSTEM - UNIVERSAL BASEPLATE
- DURACON TOTAL KNEE SYSTEM - UNIVERSAL SCREW FIXATION BASEPLATE - POROUS
- DURACON TOTAL KNEE SYSTEM - VITALLIUM CANCELLOUS SCREW
- DURACON TOTAL KNEE SYSTEM- CONDYLAR TIBIAL INSERT
- DURACON TOTAL KNEE SYSTEM- DISTAL/POST. FEMORAL SPACER 5MM,10MM,MEDIAL&LATE
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.