Medical device licence · 70354 · Class 3
JOURNEY KNEE SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed January 31, 2006. It is in Health Canada’s list of active licences.
- Licence number
- 70354
- Licence holder
- Smith & Nephew, Inc.Mississauga, Ontario, Canada
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- January 31, 2006
- Devices covered
- 21
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- JOURNE KNEE SYSTEM - PATELLA RESURFACING
- JOURNEY KNEE SYSTEM - ARTICULAR INSERT BICRUCIATE STABILIZED (BCS) STANDARD
- JOURNEY KNEE SYSTEM - BI-CRUCIATE STABILIZED ARTICULAR INSERT TRIAL STANDARD
- JOURNEY KNEE SYSTEM - BICONVEX PATELLAR TRIAL STANDARD
- JOURNEY KNEE SYSTEM - PATELLA BICONVEX
- JOURNEY KNEE SYSTEM - RESURFACING PATELLAR TRIAL STANDARD
- JOURNEY KNEE SYSTEM - UNI ALL POLY TIBIAL BASE
- JOURNEY KNEE SYSTEM - UNI ALL POLY TIBIAL INSERT TRIAL
- JOURNEY KNEE SYSTEM - UNI ARTICULAR INSERT TRIAL
- JOURNEY KNEE SYSTEM - UNI COCR FEMORAL COMPONENT
- JOURNEY KNEE SYSTEM - UNI FEMORAL LUG DRILL
- JOURNEY KNEE SYSTEM - UNI FIXED BEARING FEMORAL TRIAL
- JOURNEY KNEE SYSTEM - UNI OXINIUM FEMORAL COMPONENT
- JOURNEY KNEE SYSTEM - UNI TIBIAL BASEPLATE TRIAL LEFT MEDIAL / RIGHT LATERAL
- JOURNEY KNEE SYSTEM - UNI TIBIAL BASEPLATE TRIAL RIGHT MEDIAL / LEFT LATERAL
- JOURNEY KNEE SYSTEM - UNI TIBIAL INSERT
- JOURNEY KNEE SYSTEM - UNICONDYLAR TIBIAL BASEPLATE
- JOURNEY NON-POROUS TIBIAL BASEPLATE
- JOURNEY TIBIAL BASEPLATE TRIAL
- JOURNEYD KNEE SYSTEM - INTRAMEDULLARY DRILL
- REVISION JOURNEY BCS STANDARD ARTICULAR INSERT BI-CRUCIATE STABILIZED
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 “journey”. A notice may cover another product or only some lots: read it to see what it covers.
- JOURNEY Knee System - Femoral OXINIUM and COCR Nonporous Bi-Cruciate Stabilized (BCS) (2018-06-19)July 5, 2018 · Medical devices · Medical devices · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.