Cleared Traditional

OVOMotion Shoulder Arthroplasty System

K173964 · Arthrosurface, Inc. · Orthopedic
Apr 2018
Decision
110d
Days
Class 2
Risk

About This 510(k) Submission

K173964 is an FDA 510(k) clearance for the OVOMotion Shoulder Arthroplasty System, a Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented (Class II — Special Controls, product code HSD), submitted by Arthrosurface, Inc. (Franklin, US). The FDA issued a Cleared decision on April 18, 2018, 110 days after receiving the submission on December 29, 2017. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3690.

Submission Details

510(k) Number K173964 FDA.gov
FDA Decision Cleared SESE
Date Received December 29, 2017
Decision Date April 18, 2018
Days to Decision 110 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HSD — Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3690

Similar Devices — HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

All 70
Univers Revers CA Head and Adapter
K233260 · Arthrex, Inc. · Feb 2024
Univers Revers Humeral Cup Implant
K221232 · Arthrex, Inc. · May 2022
AGILON? XO Shoulder Replacement System
K191433 · Implantcast GmbH · Nov 2020
Biocore9 Humeral Resurfacing System
K193122 · Biocore9, LLC · May 2020
Arthrex Univers Revers Shoulder Prosthesis System
K161782 · Arthrex, Inc. · Nov 2016
Anatomical Shoulder Domelock Dome centric
K161620 · Zimmer GmbH · Nov 2016