510(k) K241878

Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem) by Stryker Corporation (Tornier, Inc.) — Product Code KWS

K241878 is an FDA 510(k) premarket notification submitted by Stryker Corporation (Tornier, Inc.) for the device "Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem)". The FDA issued a decision of Substantially Equivalent on December 6, 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.