Devices · Restor3D

Veritas Reverse Total Shoulder System

Restor3D is listed for Veritas Reverse Total Shoulder System (K253992). The FDA list gives May 7, 2026 as the date of the final decision. The lead panel is Orthopedic, and the database link on the FDA list is the 510(k) pathway. openFDA describes product code PHX as “Shoulder Prosthesis, Reverse Configuration”: 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. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253992

Official FDA database record

Date of final decision

May 7, 2026

Company on the FDA list

Restor3D

Lead panel

Orthopedic

Primary product code

PHX

openFDA device name for the code

Shoulder Prosthesis, Reverse Configuration

Device class

2

Regulation number

888.3660

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary