Cleared Traditional

Shoulder Innovations Total Shoulder System

K213615 · Shoulder Innovations, Inc. · Orthopedic

Mar 2022

Decision

116d

Days

Class 2

Risk

About This 510(k) Submission

K213615 is an FDA 510(k) clearance for the Shoulder Innovations Total 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 Shoulder Innovations, Inc. (Holland, US). The FDA issued a Cleared decision on March 11, 2022, 116 days after receiving the submission on November 15, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3660.

Submission Details

510(k) Number	K213615 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 15, 2021
Decision Date	March 11, 2022
Days to Decision	116 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