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

Comprehensive® Shoulder System

Name: Comprehensive® Shoulder System
Brand: Comprehensive® Shoulder System

Catalogue number 110030060, listed by Biomet Orthopedics, United States, under Shoulder Prosthesis, Reverse Configuration. 9 manufacturers in China are registered for this product code.

Registry build 21.09.26

9manufacturers in China registered for this device type

1catalogue number

1510(k) clearance

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 Comprehensive® Shoulder System
Listed by	Biomet Orthopedics, United States
FDA product code	PHX
Device type	Shoulder Prosthesis, Reverse Configuration
Device class	Class 2
Regulation	21 CFR 888.3660
510(k)	K152754
Record published	2016-09-24
Record revised	2025-05-30 (version 12)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Sterilisation	Moist Heat or Steam Sterilization
Prescription	Prescription only
Label carries	lot or batch number, manufacturing date

Catalogue Numbers

Catalogue numbers for Comprehensive® Shoulder System
Catalogue number	Size	Status
110030060		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
K252404	2026-04-15

Recalls Naming This Product

1 recall names this product by its own identifier, the 510(k) it is cleared under.

Recalls naming the identifiers of Comprehensive® Shoulder System
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Biomet, Inc.	510(k) number	2020-05-11	Class II	Under Investigation by firm	The product is being recalled due to the central screw drill seizing inside the Comprehensive VRS Inserter, which may lead to an extension of surgery to find a replacement device.	38	2020-11-04

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.