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

Comp Revrs 1 PC Resect Guide Assy

Name: Comp Revrs 1 PC Resect Guide Assy
Brand: Comp Revrs 1 PC Resect Guide Assy

Catalogue number SSI005290, 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 Comp Revrs 1 PC Resect Guide Assy
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)	K080642
Record published	2020-02-03
Record revised	2025-05-30 (version 3)

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

Catalogue Numbers

Catalogue numbers for Comp Revrs 1 PC Resect Guide Assy
Catalogue number	Size	Status
SSI005290		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

4 recalls name this product by its own identifiers, the 510(k) it is cleared under.

Recalls naming the identifiers of Comp Revrs 1 PC Resect Guide Assy
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Biomet, Inc.	510(k) number	2020-04-17	Class II	Process control	Potential presence of elevated endotoxin levels that exceed the specification limit	122 units	2021-06-25
Biomet, Inc.	510(k) number	2020-03-13	Class II	Under Investigation by firm	There were unknown bioburden levels prior to sterilization, which may affect sterility of the product.	125	2021-07-21
Biomet, Inc.	510(k) number	2016-12-20	Class I	Device Design	Higher than anticipated rate of fracturing due to design. Risk of revision surgery due to fracturing.	4388	2017-08-29
Biomet, Inc.	510(k) number	2013-05-15	Class II	Device Design	Biomet has initiated this action following an investigation which identified that the slot on the resection guide is offset in the wrong direction. When the slot on the resection guide is offset in the wrong direction, the Steinman pin that	17	2014-06-09

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.