Cleared Traditional

LINK Embrace Shoulder System - Reverse Configuration

K231445 · Waldemar Link GmbH & Co. KG · Orthopedic

Nov 2023

Decision

182d

Days

Class 2

Risk

About This 510(k) Submission

K231445 is an FDA 510(k) clearance for the LINK Embrace Shoulder System - Reverse Configuration, a Shoulder Prosthesis, Reverse Configuration (Class II — Special Controls, product code PHX), submitted by Waldemar Link GmbH & Co. KG (Hamburg, DE). The FDA issued a Cleared decision on November 16, 2023, 182 days after receiving the submission on May 18, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3660.

Submission Details

510(k) Number	K231445 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 18, 2023
Decision Date	November 16, 2023
Days to Decision	182 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	PHX — Shoulder Prosthesis, Reverse Configuration
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3660
Definition	Intended To Be Used To Relieve Pain And To Replace The Glenoid And Humeral Side Of The Shoulder Joint In Order To Restore Mobility In A Grossly Rotator Cuff Deficient Joint With Severe Arthropathy Or A Previous Joint Replacement With A Grossly Rotator Cuff Deficient Joint.