K170748 is an FDA 510(k) clearance for the GLOBAL UNITE Platform Shoulder System. This device is classified as a Shoulder Prosthesis, Reverse Configuration (Class II - Special Controls, product code PHX).
Submitted by Depuy Ireland UC (Ringaskiddy, IE). The FDA issued a Cleared decision on January 11, 2018, 307 days after receiving the submission on March 10, 2017.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3660. Intended To Be Used To Relieve Pain And To Replace The Glenoid And Humeral Side Of The Shoulder Joint In Order To Restore Mobility In A Grossly Rotator Cuff Deficient Joint With Severe Arthropathy Or A Previous Joint Replacement With A Grossly Rotator Cuff Deficient Joint..
| 510(k) Number | K170748 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 10, 2017 |
| Decision Date | January 11, 2018 |
| Days to Decision | 307 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | PHX — Shoulder Prosthesis, Reverse Configuration |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3660 |
| Definition | Intended To Be Used To Relieve Pain And To Replace The Glenoid And Humeral Side Of The Shoulder Joint In Order To Restore Mobility In A Grossly Rotator Cuff Deficient Joint With Severe Arthropathy Or A Previous Joint Replacement With A Grossly Rotator Cuff Deficient Joint. |