Cleared Traditional

Catalyst R1 Reverse Shoulder System

K213349 · Catalyst Orthoscience, Inc. · Orthopedic

Jun 2022

Decision

258d

Days

Class 2

Risk

About This 510(k) Submission

K213349 is an FDA 510(k) clearance for the Catalyst R1 Reverse Shoulder System, a Shoulder Prosthesis, Reverse Configuration (Class II — Special Controls, product code PHX), submitted by Catalyst Orthoscience, Inc. (Naples, US). The FDA issued a Cleared decision on June 23, 2022, 258 days after receiving the submission on October 8, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3660.

Submission Details

510(k) Number	K213349 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 08, 2021
Decision Date	June 23, 2022
Days to Decision	258 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.