Cleared Traditional

restor3d Reverse Total Shoulder Arthroplasty System

K243643 · Restor3d · Orthopedic

May 2025

Decision

174d

Days

Class 2

Risk

About This 510(k) Submission

K243643 is an FDA 510(k) clearance for the restor3d Reverse Total Shoulder Arthroplasty System, a Shoulder Prosthesis, Reverse Configuration (Class II — Special Controls, product code PHX), submitted by Restor3d (Durham, US). The FDA issued a Cleared decision on May 19, 2025, 174 days after receiving the submission on November 26, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3660.

Submission Details

510(k) Number	K243643 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 26, 2024
Decision Date	May 19, 2025
Days to Decision	174 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.