510(k) K213827

TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Humeral Resurfacing Arthroplasty System (HRA), Modular Radial Head System (MRH), Katalyst Bipolar Radial Head System (Katalyst) by Smith & Nephew, Inc. — Product Code KWS

K213827 is an FDA 510(k) premarket notification submitted by Smith & Nephew, Inc. for the device "TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Humeral Resurfacing Arthroplasty System (HRA), Modular Radial Head System (MRH), Katalyst Bipolar Radial Head System (Katalyst)". The FDA issued a decision of Substantially Equivalent on March 11, 2022. The device falls under product code KWS (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented), a Class II device regulated under 21 CFR 888.3660. Smith & Nephew, Inc. has at least 10 other 510(k) clearances on record.