Cleared Traditional

Glenoid Baseplate with Screw (K192799) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K192799 · Fx Shoulder USA, Inc. · Orthopedic device
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Feb 2020
Decision
144d
Days
Class 2
Risk

K192799 is an FDA 510(k) clearance for the Glenoid Baseplate with Screw. Classified as Shoulder Prosthesis, Reverse Configuration (product code PHX), Class II - Special Controls.

Submitted by Fx Shoulder USA, Inc. (Dallas, US). The FDA issued a Cleared decision on February 21, 2020 after a review of 144 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 Fx Shoulder USA, Inc. devices

Submission Details

510(k) Number K192799 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2019
Decision Date February 21, 2020
Days to Decision 144 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
22d slower than avg
Panel avg: 122d · This submission: 144d
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 139
Devices cleared under the same product code (PHX) and FDA review panel - the closest regulatory comparables to K192799.
Comprehensive® Reverse Shoulder
K193373 · Biomet, Inc. · Apr 2020
Medacta Shoulder System
K192967 · Medacta International S.A. · Mar 2020
DELTA XTEND(TM) Reverse Shoulder System
K192855 · Depuy(Ireland) · Feb 2020
Exactech® Equinoxe® Reverse Shoulder Glenospheres
K193098 · Exactech, Inc. · Feb 2020
Anatomical Shoulder System
K193099 · Zimmer GmbH · Jan 2020
Univers Revers Modular Glenoid System (Augemented baseplates)
K193372 · Arthrex, Inc. · Jan 2020