What is FDA product code PHX?

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.

Orthopedic › ProstheticShoulder Prosthesis, Reverse Configuration

Veritas Reverse Total Shoulder

Name: Veritas Reverse Total Shoulder
Brand: Veritas Reverse Total Shoulder

The Veritas patient specific glenoid baseplate is a component of a reverse total shoulder replacement. It is designed from CT imaging with a patient specific backside shape and central…

Registry build 21.09.26

The Veritas patient specific glenoid baseplate is a component of a reverse total shoulder replacement. It is designed from CT imaging with a patient specific backside shape and central fixation location to fit the planned glenoid anatomy.

The baseplate supports a glenosphere attached during surgery. Other system components include a humeral stem and polymer bearing, which together form the reverse shoulder articulation. Patient specific components are indicated only for primary shoulder replacement.

Listed Item

Patient specific glenoid baseplate – primary, small augment

Patient and Fixation Requirements

Patients require a functional deltoid muscle and suitable anatomy, with gross rotator cuff deficiency and severe arthropathy. Porous glenoid components are used uncemented with screw fixation. The system’s broader revision indications do not extend to its patient specific components.

9manufacturers in China registered for this device type

5catalogue numbers in this listing

3510(k) clearances naming this product code

1recall

Who Else Makes It

Concentrated in Jiangsu (5), Shanghai (3), Zhejiang (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code PHX
Manufacturer	City	Province	Registered as	Device types
Stryker Orthmed (Changzhou) Medical Instrument Co., Ltd.	Changzhou	Jiangsu	Contract manufacturer	10
Stryker Trauson (Changzhou) Medical Technology Co., Ltd.	Changzhou	Jiangsu	Contract manufacturer	3
Zimmer (Shanghai) Medical International Trading Co., Ltd.	Shanghai	Shanghai	Exporter	106
Zhejiang Biomet Medical Products Co., Ltd.	Jinhua	Zhejiang	Contract manufacturer	74
Shanghai JPY ION-Tech Co., Ltd.	Shanghai	Shanghai	Contract manufacturer	70
Changzhou Biomet Medical Devices Co., Ltd.	Changzhou	Jiangsu	Contract manufacturer	54
Arthrex (Shanghai) Co., Ltd.	Shanghai	Shanghai	Exporter	38
Johnson & Johnson Medical (Depuy – Suzhou) Ltd.	Suzhou	Jiangsu	Manufacturer	34
Changzhou Atomic HI-Tech Radiation Co., Ltd.	Changzhou	Jiangsu	Contract manufacturer	8

Record

Regulatory record for Veritas Reverse Total Shoulder
Listed by	restor3d, inc., United States
FDA product code	PHX
Device type	Shoulder Prosthesis, Reverse Configuration
Device class	Class 2
Regulation	21 CFR 888.3660
Establishment	Complaint-file establishment, Manufacturer
510(k)	K253992
Record published	2026-07-24

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Sterilisation	Moist Heat or Steam Sterilization
Single use	Yes
Prescription	Prescription only
Label carries	expiry date, serial number

Catalogue Numbers

Catalogue numbers for Veritas Reverse Total Shoulder
Catalogue number	Size	Status
6500-9002		In distribution
1500-9001-P01		In distribution
1500-9001-P02		In distribution
6500-9003		In distribution
6500-9001		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Arthrex®	Arthrex, Inc.	297
FX V135	Fx Shoulder Solutions SAS	131
Prima TT Glenoid	Limacorporate	129
Shoulder Innovations Inset Reverse Total Shoulder	Shoulder Innovations, Inc	124
Equinoxe	Exactech, Inc.	123
Veritas rTSA	restor3d, inc.	112
DJO Surgical	Encore Medical, L.P.	109
R1 Reverse Shoulder System	Catalyst Orthoscience Inc	100
Tornier Perform™ Humeral System	Tornier Inc.	96
MSS – Monobloc stem	Medacta International SA	92
SMR Shoulder	Limacorporate	90
Humelock II Cemented Reversible Shoulder	Fx Solutions	83

Showing 12 of 232. All products under Shoulder Prosthesis, Reverse Configuration

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K260556	2026-07-01
K253992	2026-05-07
K243643	2025-05-19

Recalls

1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity
2026-06-30	Class II	Device Design	Due to incorrect machining of peripheral screw hole resulting in potential for improper engagement of the peripheral screws.	59

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.