K213615 is an FDA 510(k) clearance for the Shoulder Innovations Total Shoulder System. This device is classified as a Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-constrained (Class II - Special Controls, product code PKC).
Submitted by Shoulder Innovations, Inc. (Holland, US). The FDA issued a Cleared decision on March 11, 2022, 116 days after receiving the submission on November 15, 2021.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3660. Replacement Of The Humeral Head For Total Anatomic Shoulder Arthroplasty.
| 510(k) Number | K213615 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 15, 2021 |
| Decision Date | March 11, 2022 |
| Days to Decision | 116 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | PKC - Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-constrained |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3660 |
| Definition | Replacement Of The Humeral Head For Total Anatomic Shoulder Arthroplasty |