Cleared Traditional

Archer PSI System

K243509 · 3D-Side · Orthopedic

May 2025

Decision

181d

Days

Class 2

Risk

About This 510(k) Submission

K243509 is an FDA 510(k) clearance for the Archer PSI System, a Shoulder Arthroplasty Implantation System (Class II — Special Controls, product code QHE), submitted by 3D-Side (Mont-Saint-Guibert, BE). The FDA issued a Cleared decision on May 12, 2025, 181 days after receiving the submission on November 12, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3660.

Submission Details

510(k) Number	K243509 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 12, 2024
Decision Date	May 12, 2025
Days to Decision	181 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.