Medical device licence · 27660 · Class 3
PROFEMUR HIP SYSTEM
Yes: licensed in Canada
Licence status Issued with conditions; first licensed February 26, 2001. It is in Health Canada’s list of active licences.
- Licence number
- 27660
- Licence holder
- Microport Orthopedics Inc.Arlington, TN, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- February 26, 2001
- Devices covered
- 74
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ANTERIOR FEMORAL BURR
- LINE TO LINE BROACH "PROFEMUR E"
- PROFEMUR CEMENTED STEM INSERT FOR CEMENTED STEMS
- PROFEMUR DISTAL BROACH TRIAL
- PROFEMUR DISTAL RASP
- PROFEMUR DISTAL TRIAL
- PROFEMUR E INITIAL REAMER
- PROFEMUR FEMORAL REAMER
- PROFEMUR FULLY TAPERED REAMER
- PROFEMUR GLADIATOR STARTER BROACH
- PROFEMUR GLADIATOR STARTER REAMER
- PROFEMUR HIP SYSTEM - E HIP STEM
- PROFEMUR HIP SYSTEM - NECK VAR/VAL 8DG LONG COBALT CHROME
- PROFEMUR HIP SYSTEM - PLASMA Z CLASSIC FEMORAL STEM, MONOLITHIC STANDARD
- PROFEMUR HIP SYSTEM - STEM BOWED/SPLINED/SLOTTED
- PROFEMUR HIP SYSTEM - TAPERED HIP STEM
- PROFEMUR HIP SYSTEM - Z CLASSIC FEMORAL STEM, EXT MONOLITHIC
- PROFEMUR HIP SYSTEM - Z STEM
- PROFEMUR HIP SYSTEM FEM NECK EXTRACTOR BARREL
- PROFEMUR LONG TRIAL NECK RADIO OPAQUE RADEL
- PROFEMUR LX BROACH
- PROFEMUR LX HIP STEM
- PROFEMUR METAL TRIAL NECK SHORT
- PROFEMUR MODULAR NECK (TITANIUM)
- PROFEMUR PLASMA Z CLASSIC FEMORAL STEM W/ SHORT NECK
- PROFEMUR PLASMA Z CLASSIC FEMORAL STEM W/LONG NECK (VARUS)
- PROFEMUR PLUS COCR MODULAR NECK
- PROFEMUR POCKET STEM INSERTER MODULAR
- PROFEMUR PRESERVE CANAL FINDER
- PROFEMUR PRESERVE STARTER BROACH
- PROFEMUR PRESERVE STEM PRESENTER
- PROFEMUR PROXIMAL BODY RASP
- PROFEMUR R STRAIGHT DISTAL STEM
- PROFEMUR R BOWED DISTAL STEM
- PROFEMUR R CYLINDRICAL STEM (BOWED)
- PROFEMUR R CYLINDRICAL STEM (STRAIGHT)
- PROFEMUR R DISTAL BROACH TRIAL
- PROFEMUR R FEMORAL STEM
- PROFEMUR R PROXIMAL BODY
- PROFEMUR R PROXIMAL BODY- TI PLASMA
- PROFEMUR R STEM EXTENSION
- PROFEMUR R TAPERED TRIAL STEM
- PROFEMUR RAZ HIP STEM
- PROFEMUR RENAISSANCE BROACH
- PROFEMUR RENAISSANCE CLASSIC FEMORAL STEM W/ SHORT NECK
- PROFEMUR RENAISSANCE CLASSIC FEMORAL STEM W/LONG NECK
- PROFEMUR RENAISSANCE PROXIMAL REAMER
- PROFEMUR RENAISSANCE STEMREDUCED
- PROFEMUR S ALPHA HIP STEMPLUS
- PROFEMUR S ALPHA HIP STEMREDUCED
- PROFEMUR SHORT TRIAL NECK RADIO OPAQUE RADEL
- PROFEMUR TAP METAPHYSEAL REAM
- PROFEMUR TAPERED BROACH
- PROFEMUR TAPERED REAMER STARTER REAMER
- PROFEMUR THREADED IN LINE STEM INSERTER
- PROFEMUR TL FEMORAL STEM
- PROFEMUR TL STARTER REAMER
- PROFEMUR TRIAL DISTAL STEM
- PROFEMUR WOODPECKER PNEUMATIC RASP HAMMER
- PROFEMUR Z CLASSIC FEMORAL STEM W/ LONG NECK (STRAIGHT)
- PROFEMUR Z CLASSIC FEMORAL STEM W/SHORT NECK
- PROFEMUR Z REVISION RASP
- PROFEMUR Z REVISION SLOT BROACH
- PROFEMUR Z REVISION STEM
- PROFEMUR Z SLOT BROACH
- PROFEMUR Z SLOTTED TRIAL
- PROFEMUR Z STEM MODULAR RASP CEMENTLESS
- PROFEMUR Z TI TRIAL NECK
- RASP "PROFEMUR E"
- RASP TRIAL NECK METAL
- STANDARD BROACH "PROFEMUR E"
- STEM INITIAL RASP CEMENTLESS "PROFEMUR Z"
- TAPERED DISTAL BROACH LONG "PROFEMUR R"
- TAPERED DISTAL BROACH SHORT "PROFEMUR R"
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 “profemur”. A notice may cover another product or only some lots: read it to see what it covers.
- PROFEMUR Long Titanium Modular Necks (2020-07-31)August 14, 2020 · Medical devices · Medical devices · Type II
- PROFEMUR Neck VAR/VAL 8DG Long Cobalt Chrome Neck (2015-08-07)September 1, 2015 · Medical devices · Health products · Type II
- Procotyl and Profemur ProductsOctober 1, 2012 · Medical devices · Type II
- Profemur Tapered Hip System - Profemur Z Femoral Stem - Profemur TL SystemSeptember 17, 2012 · Medical devices · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.