Cleared Special

AEQUALIS REVERSED SHOULDER PROSTHESIS

K081059 · Tornier · Orthopedic

Jul 2008

Decision

94d

Days

Class 2

Risk

About This 510(k) Submission

K081059 is an FDA 510(k) clearance for the AEQUALIS REVERSED SHOULDER PROSTHESIS, a Shoulder Prosthesis, Reverse Configuration (Class II — Special Controls, product code PHX), submitted by Tornier (Monbonnot Saint Martin, FR). The FDA issued a Cleared decision on July 17, 2008, 94 days after receiving the submission on April 14, 2008. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3660.

Submission Details

510(k) Number	K081059 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 14, 2008
Decision Date	July 17, 2008
Days to Decision	94 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.