Cleared Traditional

Catalyst OrthoScience R1 Reverse Shoulder System

K202611 · Catalyst Orthoscience, Inc. · Orthopedic

Feb 2021

Decision

156d

Days

Class 2

Risk

About This 510(k) Submission

K202611 is an FDA 510(k) clearance for the Catalyst OrthoScience 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 February 12, 2021, 156 days after receiving the submission on September 9, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3660.

Submission Details

510(k) Number	K202611 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 09, 2020
Decision Date	February 12, 2021
Days to Decision	156 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.