510(k) K241292

MyShoulder Planner (5.3SSWPL) by Medacta International S.A. — Product Code KWS

K241292 is an FDA 510(k) premarket notification submitted by Medacta International S.A. for the device "MyShoulder Planner (5.3SSWPL)". The FDA issued a decision of Substantially Equivalent on January 30, 2025. The device falls under product code KWS (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented), a Class II device regulated under 21 CFR 888.3660. Medacta International S.A. has at least 10 other 510(k) clearances on record.