Cleared Traditional

CORE Shoulder System

K241470 · LinkBio Corp. · Orthopedic

Feb 2025

Decision

272d

Days

Class 2

Risk

About This 510(k) Submission

K241470 is an FDA 510(k) clearance for the CORE Shoulder System, a Shoulder Arthroplasty Implantation System (Class II — Special Controls, product code QHE), submitted by LinkBio Corp. (Dover, US). The FDA issued a Cleared decision on February 20, 2025, 272 days after receiving the submission on May 24, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3660.

Submission Details

510(k) Number	K241470 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 24, 2024
Decision Date	February 20, 2025
Days to Decision	272 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.