Pinnacle 1217-20-044
Pinnacle 1217-20-044 (121720044) is a Class II device made by Depuy Orthopaedics, Inc., cleared under FDA 510(k) K001534 on 12 Jun 2000 (4 earlier submissions) and listed in FDA GUDID since 24 Sep 2015 (UDI-DI 10603295009580), 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 | Number10603295009580 | Date24 Sep 2015 | StatusListed |
| United States | FDA 510(k) | NumberK001534 | Date12 Jun 2000 | StatusActive |
Official records
- AccessGUDID record 10603295009580
- FDA 510(k) database K001534
- FDA 510(k) database K000306
- FDA 510(k) database K983491
- FDA 510(k) database K961186
- FDA 510(k) database K900832
Across registries
- FDA 510(k) K001534 decided 12 Jun 2000 Active
- FDA GUDID UDI-DI 10603295009580 listed 24 Sep 2015 Listed
Recalls
-
- Terminated Z-0569-2013
DePuy Orthopaedics, Inc. is issuing a voluntary recall of ten lots of the Pinnacle Cancellous Screw due to an incorrect description on the label. The label description reads Pinnacle Cannulated Screw and should read Pinnacle Cancellous Screw.
Timeline
- Cleared FDA 510(k) K900832
- Cleared FDA 510(k) K961186
- Cleared FDA 510(k) K983491
- Cleared FDA 510(k) K000306
- Cleared FDA 510(k) K001534
- Recall initiated FDA recalls Z-0569-2013
- Listed FDA GUDID 10603295009580
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Pinnacle
- Generic name
- Acetabular shell
- Model / Ref / Catalog
- 1217-20-044, 121720044
- Primary DI / UDI-DI
- 10603295009580
- FDA product code
- JDI, LPH
- GMDN term
- Acetabular shell
- Device class
- Class II
- Regulation number
- 888.3350, 888.3358
- GUDID distribution status
- In Commercial Distribution