Cleared Traditional

MyPAO SA guides

K242603 · Medacta International S.A. · Orthopedic

Nov 2025

Decision

446d

Days

Class 2

Risk

About This 510(k) Submission

K242603 is an FDA 510(k) clearance for the MyPAO SA guides, a Orthopaedic Surgical Planning And Instrument Guides (Class II — Special Controls, product code PBF), submitted by Medacta International S.A. (Castel San Pietro, CH). The FDA issued a Cleared decision on November 19, 2025, 446 days after receiving the submission on August 30, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number	K242603 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 30, 2024
Decision Date	November 19, 2025
Days to Decision	446 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	PBF — Orthopaedic Surgical Planning And Instrument Guides
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3030
Definition	As A Surgical Instrument To Assist In Pre-operative Planning And/or Guiding The Marking Of Bone And/or Guide Surgical Instruments For Orthopedic Surgical Procedures.