Cleared Traditional

K221725 - Advanced MyHip Planner (FDA 510(k) Clearance)

K221725 · Medacta International S.A. · Radiology device

Jan 2023

Decision

220d

Days

Class 2

Risk

K221725 is an FDA 510(k) clearance for the Advanced MyHip Planner. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).

Submitted by Medacta International S.A. (Castel San Pietro (Ch), CH). The FDA issued a Cleared decision on January 20, 2023, 220 days after receiving the submission on June 14, 2022.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K221725 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 14, 2022
Decision Date	January 20, 2023
Days to Decision	220 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF