510(k) K241609

Tornier Humeral Reconstruction System (Tornier HRS) by Stryker Corporation (Tornier, Inc.) — Product Code KWS

K241609 is an FDA 510(k) premarket notification submitted by Stryker Corporation (Tornier, Inc.) for the device "Tornier Humeral Reconstruction System (Tornier HRS)". The FDA issued a decision of Substantially Equivalent on September 10, 2024. The device falls under product code KWS (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented), a Class II device regulated under 21 CFR 888.3660. Stryker Corporation (Tornier, Inc.) has at least 2 other 510(k) clearances on record.