Total Shoulder Arthroplasty System
FDA product code QHQ · Class II (moderate risk) · 21 CFR 888.3660 · Orthopedic
To treat pain and lack of function in the shoulder.
1510(k) clearances
0PMA approvals
1recalls
Implantimplanted device
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K183194 | Arthrex Eclipse Shoulder Prosthesis SystemQHQ · Traditional | Arthrex, Inc. | 07/26/2019SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2042-2025 Class II | My3D Personalized Solutions Humeral Cup, Model Number: C24-0223-0003. It is a component…Required inspections were not performed on finished product prior to release and distribution. | Onkos Surgical, Inc. | 05/20/2025Open, Classified |