Bio-Modular Shoulder System 113792
Bio-Modular Shoulder System 113792 is a Class II device made by Biomet Orthopedics, Inc., cleared under FDA 510(k) K032507 on 5 Sep 2003 (2 earlier submissions) and listed in FDA GUDID since 24 Oct 2015 (UDI-DI 00880304213739), 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 | Number00880304213739 | Date24 Oct 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK032507 | Date5 Sep 2003 | StatusActive |
Official records
- AccessGUDID record 00880304213739
- FDA 510(k) database K032507
- FDA 510(k) database K992119
- FDA 510(k) database K872454
Across registries
- FDA 510(k) K032507 decided 5 Sep 2003 Active
- FDA GUDID UDI-DI 00880304213739 listed 24 Oct 2015 Listed
Recalls
-
- Terminated Z-1859-2017
Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.
Timeline
- Cleared FDA 510(k) K872454
- Cleared FDA 510(k) K992119
- Cleared FDA 510(k) K032507
- Listed FDA GUDID 00880304213739
- Recall initiated FDA recalls Z-1859-2017
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Bio-Modular Shoulder System
- Generic name
- Orthopaedic cement spacer
- Model / Ref / Catalog
- 113792
- Primary DI / UDI-DI
- 00880304213739
- FDA product code
- HSD, KWT, KWS
- GMDN term
- Orthopaedic cement spacer
- Device class
- Class II
- Regulation number
- 888.3690, 888.3650, 888.3660
- GUDID distribution status
- In Commercial Distribution