510(k) K251686

Tornier Humeral Reconstruction System Max (Tornier HRS Max) by Tornier, Inc. — Product Code KWT

K251686 is an FDA 510(k) premarket notification submitted by Tornier, Inc. for the device "Tornier Humeral Reconstruction System Max (Tornier HRS Max)". The FDA issued a decision of Substantially Equivalent on October 30, 2025. The device falls under product code KWT (Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented), a Class II device regulated under 21 CFR 888.3650. Tornier, Inc. has at least 10 other 510(k) clearances on record.