Cleared Traditional

K200895 - Univers Revers Modular Glenoid System

K200895 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 Traditional 510(k) pathway after a 132-day FDA review.

K200895 · Arthrex, Inc. · Orthopedic device
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Aug 2020
Decision
132d
Days
Class 2
Risk

K200895 is an FDA 510(k) clearance for the Univers Revers Modular Glenoid System, Half Augment Baseplate. 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 August 13, 2020 after a review of 132 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

FDA 510(k) Submission Details - K200895

510(k) Number K200895 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 2020
Decision Date August 13, 2020
Days to Decision 132 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
10d slower than avg
Panel avg: 122d · This submission: 132d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 183
Devices cleared under the same product code (PHX) and FDA review panel - the closest regulatory comparables to K200895.
LINK Embrace Shoulder System - Reverse Configuration
K200368 · Waldemar Link GmbH & Co. KG · Feb 2021
GLOBAL UNITE™ Platform Shoulder System
K202098 · Depuy Ireland UC · Nov 2020
SMR TT Augmented Glenoid System
K200171 · Lima Corporate S.P.A. · Nov 2020
Lateralized Glenosphere
K193175 · Medacta Inernational SA · Aug 2020
Humelock TiN Coated Glenosphere
K191146 · Fx Shoulder USA, Inc. · Jul 2020
Humeral Cup Stability & Humeral Cup 135/145o Stability
K193394 · Fx Shoulder USA, Inc. · Apr 2020