Cleared Traditional

AEQUALIS REVERSED SHOULDER PROSTHESIS

K041873 · Tornier · Orthopedic

Aug 2004

Decision

44d

Days

Class 2

Risk

About This 510(k) Submission

K041873 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 (Montbonnot, FR). The FDA issued a Cleared decision on August 25, 2004, 44 days after receiving the submission on July 12, 2004. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3660.

Submission Details

510(k) Number	K041873 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 12, 2004
Decision Date	August 25, 2004
Days to Decision	44 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.