Smartset 5450-35-500
Smartset 5450-35-500 (545035500) is a Class I device made by Depuy (Ireland), cleared under FDA 510(k) K081163 on 14 May 2008 (6 earlier submissions) and listed in FDA GUDID since 24 Sep 2015 (UDI-DI 10603295174288), active as of 9 Nov 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 | Number10603295174288 | Date24 Sep 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK081163 | Date14 May 2008 | StatusActive |
Official records
- AccessGUDID record 10603295174288
- FDA 510(k) database K081163
- FDA 510(k) database K061144
- FDA 510(k) database K053445
- FDA 510(k) database K053002
- FDA 510(k) database K033382
- FDA 510(k) database K033563
- FDA 510(k) database K023012
Across registries
- FDA 510(k) K081163 decided 14 May 2008 Active
- FDA GUDID UDI-DI 10603295174288 listed 24 Sep 2015 Listed
Recalls
-
- Terminated Z-1246-2015
One lot of SMARTSET GHV Gentamicin Bone Cement is partially agglomerated . This may result in surgical delays while a replacement package of cement is retrieved and mixed.
Timeline
- Cleared FDA 510(k) K023012
- Cleared FDA 510(k) K033382
- Cleared FDA 510(k) K033563
- Cleared FDA 510(k) K053002
- Cleared FDA 510(k) K053445
- Cleared FDA 510(k) K061144
- Cleared FDA 510(k) K081163
- Recall initiated FDA recalls Z-1246-2015
- Listed FDA GUDID 10603295174288
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Smartset
- Generic name
- Orthopaedic cement, antimicrobial
- Model / Ref / Catalog
- 5450-35-500, 545035500
- Primary DI / UDI-DI
- 10603295174288
- FDA product code
- JDZ, LOD, MBB, KIH
- GMDN term
- Orthopaedic cement, antimicrobial
- Device class
- Class I
- Regulation number
- 888.4210, 888.3027, 888.4200
- GUDID distribution status
- In Commercial Distribution