Cleared Traditional

MyShoulder Planner (5.3SSWPL)

K241292 · Medacta International S.A. · Orthopedic

Jan 2025

Decision

267d

Days

Class 2

Risk

About This 510(k) Submission

K241292 is an FDA 510(k) clearance for the MyShoulder Planner (5.3SSWPL), a Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented (Class II — Special Controls, product code KWS), submitted by Medacta International S.A. (Castel San Pietro, CH). The FDA issued a Cleared decision on January 30, 2025, 267 days after receiving the submission on May 8, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3660.

Submission Details

510(k) Number	K241292 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 08, 2024
Decision Date	January 30, 2025
Days to Decision	267 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	KWS — Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3660