Medical device licence · 81549 · Class 3
POLARSTEM HIP STEM SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed December 21, 2009. It is in Health Canada’s list of active licences.
- Licence number
- 81549
- Licence holder
- Smith & Nephew Orthopaedics AgWarwickshire, United Kingdom
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- December 21, 2009
- Devices covered
- 20
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- POLARSTEM - STEM STD. TI/HA WITH COLLAR
- POLARSTEM - STEM VALGUS WITH TI/HA
- POLARSTEM CALCAR PLANER
- POLARSTEM CALCAR REAMER
- POLARSTEM CALCAR REAMER GUIDE
- POLARSTEM DAA DOUBLE-OFFSET ADAPTER
- POLARSTEM DAA OFFSET ADAPTER, 45 DEGREE
- POLARSTEM DETACHABLE RASP
- POLARSTEM STARTER RASP
- POLARSTEM STEM LATERAL CEMENTED
- POLARSTEM STEM LATERAL TI/HA WITH COLLAR
- POLARSTEM STEM LATERAL WITH TI/HA
- POLARSTEM STEM STANDARD CEMENTED
- POLARSTEM STEM STANDARD WITH TI/HA
- POLARSTEM TRIAL BALL HEAD
- POLARSTEM TRIAL NECK LATERALIZED
- POLARSTEM TRIAL NECK STANDARD
- POLARSTEM TRIAL NECK WITH COLLAR LATERAL
- POLARSTEM TRIAL NECK WITH COLLAR STANDARD
- POLASTEM TRIAL NECK VALGUS
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 “polarstem”. A notice may cover another product or only some lots: read it to see what it covers.
- POLARSTEM COLLAR Reamer Guide (2020-07-22)August 14, 2020 · 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.