Cleared Traditional

Arthrex Virtual Implant Positioning (VIP) System Software

K241097 · Arthrex, Inc. · Orthopedic

Oct 2024

Decision

163d

Days

Class 2

Risk

About This 510(k) Submission

K241097 is an FDA 510(k) clearance for the Arthrex Virtual Implant Positioning (VIP) System Software, a Shoulder Arthroplasty Implantation System (Class II — Special Controls, product code QHE), submitted by Arthrex, Inc. (Naples, US). The FDA issued a Cleared decision on October 2, 2024, 163 days after receiving the submission on April 22, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3660.

Submission Details

510(k) Number	K241097 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 22, 2024
Decision Date	October 02, 2024
Days to Decision	163 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	QHE — Shoulder Arthroplasty Implantation System
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3660
Definition	Intended To Be Used To Assist In The Implantation Of A Specific Shoulder Arthroplasty Device Or A Set Of Specific Shoulder Arthroplasty Devices. Indicated To Include Guiding Alignment, Making Or Establishing Cuts, Selecting, Sizing, Attaching, Positioning Or Orienting Implant Components.