Cleared Special

Aequalis PerFORM Reversed Glenoid, Aequalis PerFORM + Reversed Glenoid

K183696 · Tornier, Inc. · Orthopedic

Jan 2019

Decision

30d

Days

Class 2

Risk

About This 510(k) Submission

K183696 is an FDA 510(k) clearance for the Aequalis PerFORM Reversed Glenoid, Aequalis PerFORM + Reversed Glenoid, a Shoulder Prosthesis, Reverse Configuration (Class II — Special Controls, product code PHX), submitted by Tornier, Inc. (Bloomington, US). The FDA issued a Cleared decision on January 30, 2019, 30 days after receiving the submission on December 31, 2018. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3660.

Submission Details

510(k) Number	K183696 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 31, 2018
Decision Date	January 30, 2019
Days to Decision	30 days
Submission Type	Special
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.