TriFit TS Blade Stem 694.0001
by Corin Ltd
TriFit TS Blade Stem 694.0001 is a Class II device made by Corin Ltd, cleared under FDA 510(k) K121563 on 5 Oct 2012 and listed in FDA GUDID since 17 Aug 2016 (UDI-DI 05055343877173), active as of 22 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number05055343877173 | Date17 Aug 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK121563 | Date5 Oct 2012 | StatusActive |
Official records
- AccessGUDID record 05055343877173
- FDA 510(k) database K121563
Across registries
- FDA 510(k) K121563 decided 5 Oct 2012 Active
- FDA GUDID UDI-DI 05055343877173 listed 17 Aug 2016 Listed
Recalls
-
- Terminated Z-2603-2021
The packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or contamination of the devices.
Timeline
- Cleared FDA 510(k) K121563
- Listed FDA GUDID 05055343877173
- Recall initiated FDA recalls Z-2603-2021
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- TriFit TS Blade Stem
- Generic name
- Coated hip femur prosthesis, modular
- Model / Ref / Catalog
- 694.0001
- Primary DI / UDI-DI
- 05055343877173
- 510(k) Number
- FDA product code
- KWL, KWY, MEH, LZO
- GMDN term
- Coated hip femur prosthesis, modular
- Device class
- Class II
- Regulation number
- 888.3360, 888.3390, 888.3353
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Radiation Sterilization
Similar devices in this category
Other devices filed under Coated hip femur prosthesis, modular.