K221758 is an FDA 510(k) clearance for the SMR Stemless Anatomic. 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 Lima Corporate S.P.A. (Villanova Di San Daniele Del Friuli, IT). The FDA issued a Cleared decision on March 17, 2023, 274 days after receiving the submission on June 16, 2022.
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 | K221758 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 16, 2022 |
| Decision Date | March 17, 2023 |
| 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 |