Cleared Special

AEQUALIS SHOULDER FRACTURE SYSTEM, AEQUALIS REVERSED SHOULDER PROSTHESIS, AEQUALIS REVERSED FRACTURE SHOULDER PROSTHESIS

K112144 · Tornier · Orthopedic

Mar 2012

Decision

231d

Days

Class 2

Risk

About This 510(k) Submission

K112144 is an FDA 510(k) clearance for the AEQUALIS SHOULDER FRACTURE SYSTEM, AEQUALIS REVERSED SHOULDER PROSTHESIS, AEQUALIS REVERSED FRACTURE 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 March 13, 2012, 231 days after receiving the submission on July 26, 2011. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3660.

Submission Details

510(k) Number	K112144 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 26, 2011
Decision Date	March 13, 2012
Days to Decision	231 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.