K241043 is an FDA 510(k) clearance for the Augment Off-Axis Instrument System. This device is classified as a Shoulder Prosthesis, Reverse Configuration (Class II - Special Controls, product code PHX).
Submitted by Fix Surgical (Conshohocken, US). The FDA issued a Cleared decision on May 15, 2024, 28 days after receiving the submission on April 17, 2024.
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 | K241043 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 17, 2024 |
| Decision Date | May 15, 2024 |
| Days to Decision | 28 days |
| Submission Type | Special |
| 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. |