Cleared Special

Shoulder Innovations Total Shoulder System

K192365 · Shoulder Innovations, Inc. · Orthopedic

Nov 2019

Decision

91d

Days

Class 2

Risk

About This 510(k) Submission

K192365 is an FDA 510(k) clearance for the Shoulder Innovations Total Shoulder System, a Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented (Class II — Special Controls, product code KWT), submitted by Shoulder Innovations, Inc. (Holland, US). The FDA issued a Cleared decision on November 29, 2019, 91 days after receiving the submission on August 30, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3650.

Submission Details

510(k) Number	K192365 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 30, 2019
Decision Date	November 29, 2019
Days to Decision	91 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	KWT — Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3650