Cleared Traditional

Anatomical Shoulder System

K193099 · Zimmer GmbH · Orthopedic

Jan 2020

Decision

83d

Days

Class 2

Risk

About This 510(k) Submission

K193099 is an FDA 510(k) clearance for the Anatomical Shoulder System, a Shoulder Prosthesis, Reverse Configuration (Class II — Special Controls, product code PHX), submitted by Zimmer GmbH (Winterthur, CH). The FDA issued a Cleared decision on January 29, 2020, 83 days after receiving the submission on November 7, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3660.

Submission Details

510(k) Number	K193099 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 07, 2019
Decision Date	January 29, 2020
Days to Decision	83 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.