Bio-Modular 406533
Bio-Modular 406533 is a Class II device made by Biomet Orthopedics, Inc., cleared under FDA 510(k) K140652 on 3 Jul 2014 (1 earlier submission) and listed in FDA GUDID since 20 Mar 2017 (UDI-DI 00880304006799), active as of 23 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 | Number00880304006799 | Date20 Mar 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK140652 | Date3 Jul 2014 | StatusActive |
Official records
- AccessGUDID record 00880304006799
- FDA 510(k) database K140652
- FDA 510(k) database K030710
Across registries
- FDA 510(k) K140652 decided 3 Jul 2014 Active
- FDA GUDID UDI-DI 00880304006799 listed 20 Mar 2017 Listed
Recalls
-
- Terminated Z-0474-2013
The items in this lot are missing the ion implantation feature. The surface of the head may be softer and more prone to scratching, which in tum could potentially cause higher wear of the poly bearing. Increased wear could potentially lead to a shorter implant life.
Timeline
- Cleared FDA 510(k) K030710
- Recall initiated FDA recalls Z-0474-2013
- Cleared FDA 510(k) K140652
- Listed FDA GUDID 00880304006799
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Bio-Modular
- Generic name
- Humeral head prosthesis trial, reusable
- Model / Ref / Catalog
- 406533
- Primary DI / UDI-DI
- 00880304006799
- FDA product code
- KWT, HSD, MBF, KWS, PHX
- GMDN term
- Humeral head prosthesis trial, reusable
- Device class
- Class II
- Regulation number
- 888.3650, 888.3690, 888.3670, 888.3660
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization