TaperFit Cemented Hip System 279.000
by Corin Ltd
TaperFit Cemented Hip System 279.000 is a Class II device made by Corin Ltd, cleared under FDA 510(k) K142761 on 3 Apr 2015 and listed in FDA GUDID since 17 Aug 2016 (UDI-DI 05055343888056), 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 | Number05055343888056 | Date17 Aug 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK142761 | Date3 Apr 2015 | StatusActive |
Official records
- AccessGUDID record 05055343888056
- FDA 510(k) database K142761
Across registries
- FDA 510(k) K142761 decided 3 Apr 2015 Active
- FDA GUDID UDI-DI 05055343888056 listed 17 Aug 2016 Listed
Recalls
-
- Terminated Z-1667-2022
Some of the devices did not pass fatigue testing.
Timeline
- Cleared FDA 510(k) K142761
- Listed FDA GUDID 05055343888056
- Recall initiated FDA recalls Z-1667-2022
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- TaperFit Cemented Hip System
- Generic name
- Orthopaedic inorganic implant inserter/extractor, reusable
- Model / Ref / Catalog
- 279.000
- Primary DI / UDI-DI
- 05055343888056
- 510(k) Number
- FDA product code
- JDG, JDI
- GMDN term
- Orthopaedic inorganic implant inserter/extractor, reusable
- Device class
- Class II
- Regulation number
- 888.3360, 888.3350
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
Similar devices in this category
Other devices filed under Orthopaedic inorganic implant inserter/extractor, reusable.