Medical device licence · 81891 · Class 2
TRIATHLON KNEE TRIALS
Yes: licensed in Canada
Licence status Issued (active); first licensed January 27, 2010. It is in Health Canada’s list of active licences.
- Licence number
- 81891
- Licence holder
- Howmedica Osteonics CorporationMahwah, NJ, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- January 27, 2010
- Devices covered
- 17
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- FEMORAL POSTERIOR AUGMENT TRIAL
- TRIATHLON - ASYMMETRIC PATELLA TRIAL
- TRIATHLON - CR FEMORAL TRIAL
- TRIATHLON - CR TIBIAL TRIALS
- TRIATHLON - CS TIBIAL INSERT TRIAL
- TRIATHLON - PKR DRILL THRU FEMORAL TRIAL
- TRIATHLON - PKR TIBIAL TRIAL
- TRIATHLON - PS FEMORAL TRIAL
- TRIATHLON - PS TIBIAL INSERT TRIAL
- TRIATHLON - SYMMETRIC PATELLA TRIAL
- TRIATHLON FEMORAL DISTAL AUGMENT TRIAL
- TRIATHLON SOLID CR TIBIAL INSERT TRIAL
- TRIATHLON SOLID CS TIBIAL INSERT TRIAL
- TRIATHLON SOLID PS TIBIAL INSERT TRIAL
- TRIATHLON TS FEMUR TRIAL
- TRIATHLON TS UNIVERSAL BASEPLATE TRIAL
- TS + TIBIAL INSERT TRIAL
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 “triathlon”. A notice may cover another product or only some lots: read it to see what it covers.
- Triathlon Total Knee SystemsFebruary 16, 2024 · Orthopaedics · Performance · Type II
- Stryker Triathlon Fixation PegAugust 31, 2023 · Orthopaedics · Performance · Type II
- Triathlon SystemMarch 14, 2022 · Orthopaedics · Labelling and packaging · Type II
- SPECIALTY TRIATHLON TS TRIAL CUTTING GUIDE (2021-03-04)March 16, 2021 · Medical devices · Medical devices · Type I
- Triathlon Femoral Distal Augments (10 AND 15 mm, SIZE 2, LEFT and RIGHT) (2019-08-09)August 23, 2019 · Medical devices · Medical devices · Type II
- Triathlon Total Knee System - Tibial Augment (2018-02-02)February 16, 2018 · Medical devices · Medical devices · Type III
- Triathlon Total Knee System - Ts Femoral ComponentJuly 18, 2017 · Medical devices · Type II
- TRIATHLON MODULAR HANDLE (2016-06-29)July 19, 2016 · Medical devices · Medical devices · Type II
- TRIATHLON MIS DISTAL CAPTURE (2015-10-01)October 22, 2015 · Medical devices · Health products · Type II
- Triathlon Distal Capture Assembly (2015-02-12)March 20, 2015 · Medical devices · Health products · Type II
- Triathlon Tibial Alignment HandleJanuary 9, 2012 · Medical devices · Medical devices · Type II
- Triathlon Mobile Bearing Knee Surgical ProtocolJanuary 9, 2012 · 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.