Cleared Special

K212710 - GLOBAL UNITE™ Platform Shoulder System

K212710 is an FDA 510(k) clearance for GLOBAL UNITE Platform Shoulder System, manufactured by Depuy Ireland UC. The device is a Class 2 Orthopedic device with product code PHX cleared through the Special 510(k) pathway after a 20-day FDA review.

K212710 · Depuy Ireland UC · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2021
Decision
20d
Days
Class 2
Risk

K212710 is an FDA 510(k) clearance for the GLOBAL UNITE™ Platform Shoulder System. Classified as Shoulder Prosthesis, Reverse Configuration (product code PHX), Class II - Special Controls.

Submitted by Depuy Ireland UC (Cork, IE). The FDA issued a Cleared decision on September 15, 2021 after a review of 20 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 - K212710

510(k) Number K212710 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 2021
Decision Date September 15, 2021
Days to Decision 20 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
102d faster than avg
Panel avg: 122d · This submission: 20d
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 Consultant

DePuy Mitek, Inc.
Yayoi Fujimaki

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K212710.
Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient Specific Instrumentation
K211359 · Tornier, Inc. · Nov 2021
Comprehensive® Convertible Glenoid - Vivacit-E Liner
K211729 · Biomet Manufacturing Corp · Nov 2021
Tomier Perform™ Reversed Glenoid Cannulated Glenospheres
K213124 · Tornier, Inc. · Oct 2021
Univers Revers Modular Glenoid System, Standard Augment Baseplates
K211074 · Arthrex, Inc. · Sep 2021
Lateralized and Augmented Baseplates
K210790 · Fx Shoulder USA, Inc. · Aug 2021
Inset Reverse Total Shoulder System
K210533 · Shoulder Innovations, Inc. · Aug 2021
K212710 · GLOBAL UNITE™ Platform Shoulder System
Download PDF FDA Summary Depuy Ireland UC