Cleared Special

K263421 - Veritas Shoulder System

K263421 is an FDA 510(k) clearance for Veritas Shoulder System, manufactured by Restor3D, Inc.. The device is a Class 2 Orthopedic device with product code PHX cleared through the Special 510(k) pathway after a 27-day FDA review.

K263421 · Restor3D, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
27d
Days
Class 2
Risk

K263421 is an FDA 510(k) clearance for the Veritas Shoulder System. Classified as Shoulder Prosthesis, Reverse Configuration (product code PHX), Class II - Special Controls.

Submitted by Restor3D, Inc. (Durham, US). The FDA issued a Cleared decision on October 22, 2026 after a review of 27 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 - K263421

510(k) Number K263421 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2026
Decision Date October 22, 2026
Days to Decision 27 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
95d faster than avg
Panel avg: 122d · This submission: 27d
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 K263421.
AltiVate Reverse® Glenosphere with RAVN™ Technology
K263086 · Encore Medical, L.P. · Oct 2026
Veritas Shoulder System
K260556 · Restor3d · Jul 2026
Augment Off-Axis Instrument System
K261683 · Zimmer, Inc. · Jun 2026
Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder System
K260102 · Stryker Corporation (Tornier, Inc.) · Jun 2026
MSS - Humeral reverse liners extension
K261016 · Medacta International, SA · Jun 2026
Veritas Reverse Total Shoulder System
K253992 · Restor3d · May 2026
K263421 · Veritas Shoulder System
Download PDF FDA Summary Restor3D, Inc.