Cleared Traditional

AltiVate Anatomic to Reverse Conversion Module

K173073 · Encore Medical, L.P. · Orthopedic

Dec 2017

Decision

88d

Days

Class 2

Risk

About This 510(k) Submission

K173073 is an FDA 510(k) clearance for the AltiVate Anatomic to Reverse Conversion Module, a Shoulder Prosthesis, Reverse Configuration (Class II — Special Controls, product code PHX), submitted by Encore Medical, L.P. (Austin, US). The FDA issued a Cleared decision on December 26, 2017, 88 days after receiving the submission on September 29, 2017. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3660.

Submission Details

510(k) Number	K173073 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 29, 2017
Decision Date	December 26, 2017
Days to Decision	88 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.