Cleared Special

K193372 - Univers Revers Modular Glenoid System (Augemented baseplates)

K193372 is an FDA 510(k) clearance for Univers Revers Modular Glenoid System (..., manufactured by Arthrex, Inc.. The device is a Class 2 Orthopedic device with product code PHX cleared through the Special 510(k) pathway after a 36-day FDA review.

K193372 · Arthrex, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2020
Decision
36d
Days
Class 2
Risk

K193372 is an FDA 510(k) clearance for the Univers Revers Modular Glenoid System (Augemented baseplates). 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 January 10, 2020 after a review of 36 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3660 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K193372

510(k) Number K193372 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 2019
Decision Date January 10, 2020
Days to Decision 36 days
Submission Type Special
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
86d faster than avg
Panel avg: 122d · This submission: 36d
Pathway characteristics
Modification to existing cleared device.

PHX Device Classification - Class 2, Special Controls

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 206
Devices cleared under the same product code (PHX) and FDA review panel - the closest regulatory comparables to K193372.
Glenoid Baseplate with Screw
K192799 · Fx Shoulder USA, Inc. · Feb 2020
Exactech® Equinoxe® Reverse Shoulder Glenospheres
K193098 · Exactech, Inc. · Feb 2020
Anatomical Shoulder System
K193099 · Zimmer GmbH · Jan 2020
Arthrex Univers Revers Modular Glenoid System
K191960 · Arthrex, Inc. · Dec 2019
MyShoulder Placement Guides
K190738 · Medacta International S.A. · Dec 2019
Integra TITAN Reverse Shoulder System
K190588 · Integra LifeSciences Corporation · Dec 2019
K193372 · Univers Revers Modular Glenoid System (Augemented baseplates)
Download PDF FDA Summary Arthrex, Inc.