510(k) K203108

Ignite Stemless Anatomic Shoulder System by Ignite Orthopedics, LLC — Product Code PKC

K203108 is an FDA 510(k) premarket notification submitted by Ignite Orthopedics, LLC for the device "Ignite Stemless Anatomic Shoulder System". The FDA issued a decision of Substantially Equivalent on July 16, 2021. 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. Ignite Orthopedics, LLC has at least 2 other 510(k) clearances on record.