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

SmartBase Core

Name: SmartBase Core
Brand: SmartBase Core

The SmartBase Core is the base component of the SmartBase Assembly, which is used to set the Intelligent Reusable Instrument (IRI). The SmartBase Assembly is indicated for use as part of…

Registry build 21.09.26

The SmartBase Core is the base component of the SmartBase Assembly, which is used to set the Intelligent Reusable Instrument (IRI). The SmartBase Assembly is indicated for use as part of the Arthrex Glenoid Intelligent Reusable Instrument System (IRIS) in Total Shoulder Arthroplasty (TSA).

9manufacturers in China registered for this device type

1catalogue number

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 SmartBase Core
Listed by	Custom Orthopaedic Solutions, Inc., United States
FDA product code	PHX
Device type	Shoulder Prosthesis, Reverse Configuration
Device class	Class 2
Regulation	21 CFR 888.3660
Record published	2016-09-02
Record revised	2024-03-12 (version 8)

Specifications

Specifications
MRI safety	MR Unsafe
Sterilisation	Moist Heat or Steam Sterilization
Prescription	Prescription only
Latex	Labelled latex-free
Label carries	lot or batch number
Storage	Special storage condition: Store in a dry, dark, cool place.
Sizes	Lumen/inner diameter 4.9 mm; height 42 mm
Distribution end date	2019-06-21

Catalogue Numbers

Catalogue numbers for SmartBase Core
Catalogue number	Size	Status
J	Lumen/Inner Diameter 4.9 mm	Withdrawn

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

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.