Cleared Traditional

Humeral Short Stem System

K173824 · Shoulder Innovations, Inc. · Orthopedic

Oct 2018

Decision

309d

Days

Class 2

Risk

About This 510(k) Submission

K173824 is an FDA 510(k) clearance for the Humeral Short Stem System, a Prosthesis, Shoulder, Semi-constrained, Metal/polymer, Uncemented (Class II — Special Controls, product code MBF), submitted by Shoulder Innovations, Inc. (Holland, US). The FDA issued a Cleared decision on October 23, 2018, 309 days after receiving the submission on December 18, 2017. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3670.

Submission Details

510(k) Number	K173824 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 18, 2017
Decision Date	October 23, 2018
Days to Decision	309 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	MBF — Prosthesis, Shoulder, Semi-constrained, Metal/polymer, Uncemented
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3670