Cleared Traditional

Simpliciti Shoulder System

K143552 · Tornier, Inc. · Orthopedic

Mar 2015

Decision

79d

Days

Class 2

Risk

About This 510(k) Submission

K143552 is an FDA 510(k) clearance for the Simpliciti Shoulder System, a Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-constrained (Class II — Special Controls, product code PKC), submitted by Tornier, Inc. (Bloomington, US). The FDA issued a Cleared decision on March 4, 2015, 79 days after receiving the submission on December 15, 2014. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3660.

Submission Details

510(k) Number	K143552 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 15, 2014
Decision Date	March 04, 2015
Days to Decision	79 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	PKC — Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-constrained
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3660
Definition	Replacement Of The Humeral Head For Total Anatomic Shoulder Arthroplasty