K203108 is an FDA 510(k) clearance for the Ignite Stemless Anatomic 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 Ignite Orthopedics, LLC (Winona Lake, US). The FDA issued a Cleared decision on July 16, 2021, 274 days after receiving the submission on October 15, 2020.
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 | K203108 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 15, 2020 |
| Decision Date | July 16, 2021 |
| Days to Decision | 274 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 |