Cleared Traditional

OVOMotion Reverse Shoulder Arthroplasty System

K203375 · Arthrosurface, Inc. · Orthopedic

Jun 2021

Decision

220d

Days

Class 2

Risk

About This 510(k) Submission

K203375 is an FDA 510(k) clearance for the OVOMotion Reverse Shoulder Arthroplasty System, a Shoulder Prosthesis, Reverse Configuration (Class II — Special Controls, product code PHX), submitted by Arthrosurface, Inc. (Franklin, US). The FDA issued a Cleared decision on June 24, 2021, 220 days after receiving the submission on November 16, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3660.

Submission Details

510(k) Number	K203375 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 16, 2020
Decision Date	June 24, 2021
Days to Decision	220 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.