Hexloc Modular Hip System 12-104354
Hexloc Modular Hip System 12-104354 is a Class II device made by Biomet Orthopedics, Inc., cleared under FDA 510(k) K023357 on 6 Nov 2002 (1 earlier submission) and listed in FDA GUDID since 24 Oct 2015 (UDI-DI 00880304220195), 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 | Number00880304220195 | Date24 Oct 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK023357 | Date6 Nov 2002 | StatusActive |
Official records
- AccessGUDID record 00880304220195
- FDA 510(k) database K023357
- FDA 510(k) database K926107
Across registries
- FDA 510(k) K023357 decided 6 Nov 2002 Active
- FDA GUDID UDI-DI 00880304220195 listed 24 Oct 2015 Listed
Recalls
-
- Terminated Z-1860-2017
Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.
Timeline
- Cleared FDA 510(k) K926107
- Cleared FDA 510(k) K023357
- Listed FDA GUDID 00880304220195
- Recall initiated FDA recalls Z-1860-2017
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Hexloc Modular Hip System
- Generic name
- Non-constrained polyethylene acetabular liner
- Model / Ref / Catalog
- 12-104354
- Primary DI / UDI-DI
- 00880304220195
- FDA product code
- JDI, LPH, LZO
- GMDN term
- Non-constrained polyethylene acetabular liner
- Device class
- Class II
- Regulation number
- 888.3350, 888.3358, 888.3353
- GUDID distribution status
- In Commercial Distribution