Cleared Traditional

K173900 - Arthrex Univers Revers Modular Glenoid ...

K173900 is the FDA 510(k) clearance for Arthrex Univers Revers Modular Glenoid ... by Arthrex, Inc.. It is a Class 2 Orthopedic device (product code PHX) cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K173900 · Arthrex, Inc. · Orthopedic device
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Apr 2018
Decision
119d
Days
Class 2
Risk

K173900 is an FDA 510(k) clearance for the Arthrex Univers Revers Modular Glenoid System. Classified as Shoulder Prosthesis, Reverse Configuration (product code PHX), Class II - Special Controls.

Submitted by Arthrex, Inc. (Naples, US). The FDA issued a Cleared decision on April 20, 2018 after a review of 119 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3660 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Arthrex, Inc. devices

Submission Details

510(k) Number K173900 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2017
Decision Date April 20, 2018
Days to Decision 119 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
3d faster than avg
Panel avg: 122d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PHX Shoulder Prosthesis, Reverse Configuration
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3660
Definition Intended To Be Used To Relieve Pain And To Replace The Glenoid And Humeral Side Of The Shoulder Joint In Order To Restore Mobility In A Grossly Rotator Cuff Deficient Joint With Severe Arthropathy Or A Previous Joint Replacement With A Grossly Rotator Cuff Deficient Joint.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - PHX Shoulder Prosthesis, Reverse Configuration

All 178
Devices cleared under the same product code (PHX) and FDA review panel - the closest regulatory comparables to K173900.
Comprehensive Reverse Shoulder System
K181611 · Biomet Manufacturing Corp · Sep 2018
Exactech Equinoxe Small Reverse Shoulder System
K180632 · Exactech, Inc. · Jul 2018
Integra TITAN Reverse Shoulder System
K173717 · Integra LifeSciences Corporation · Jun 2018
Medacta Shoulder System Short Humeral Diaphysis
K180089 · Medacta International S.A. · Apr 2018
Arthrex UNIVERS REVERS COATED BASEPLATE
K172371 · Arthrex, Inc. · Mar 2018
Comprehensive Segmental Revision System (SRS)
K173411 · Biomet Manufacturing Corp · Feb 2018