510(k) K213615

Shoulder Innovations Total Shoulder System by Shoulder Innovations, Inc. — Product Code PKC

K213615 is an FDA 510(k) premarket notification submitted by Shoulder Innovations, Inc. for the device "Shoulder Innovations Total Shoulder System". The FDA issued a decision of Substantially Equivalent on March 11, 2022. The device falls under product code PKC (Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained), a Class II device regulated under 21 CFR 888.3660. Shoulder Innovations, Inc. has at least 10 other 510(k) clearances on record.