K193226 is an FDA 510(k) clearance for the AltiVate Anatomic Canal-Sparing (CS) Shoulder. 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 Encore Medical, L.P. (Austin, US). The FDA issued a Cleared decision on June 3, 2020, 194 days after receiving the submission on November 22, 2019.
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 | K193226 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 22, 2019 |
| Decision Date | June 03, 2020 |
| Days to Decision | 194 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 |