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

Identity Humeral

Name: Identity Humeral
Brand: Identity Humeral

4 catalogue numbers from 110047153, listed by Zimmer, Inc., 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

4catalogue numbers in this listing

10510(k) clearances naming this product code

5recalls on this code

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 Identity Humeral
Listed by	Zimmer, Inc., United States
FDA product code	PHX
Device type	Shoulder Prosthesis, Reverse Configuration
Device class	Class 2
Regulation	21 CFR 888.3660
Establishment	Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter
510(k)	K251098
Record published	2025-09-17

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Sterilisation	Moist Heat or Steam Sterilization
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date, manufacturing date
Sizes	Outer diameter 4 to 11 mm

Catalogue Numbers

Catalogue numbers for Identity Humeral
Catalogue number	Size	Status
110047153	Outer Diameter 11 mm	In distribution
110047148	Outer Diameter 6 mm	In distribution
110047150	Outer Diameter 8 mm	In distribution
110047164	Outer Diameter 4 mm	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
K261683	2026-06-16
K193099	2020-01-29
K172767	2017-11-30
K170711	2017-06-01
K133378	2014-05-12
K130661	2013-05-09
K122692	2012-12-03
K060704	2006-05-19
K053274	2006-01-25
K052906	2005-12-19

Recalls

5 of these are 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
2026-05-20	Class II	Under Investigation by firm	Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.	13 units
2026-05-20	Class II	Under Investigation by firm	Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.	435 units
2026-05-20	Class II	Under Investigation by firm	Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.	11 units
2026-05-20	Class II	Under Investigation by firm	Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.	429 units
2026-05-20	Class II	Under Investigation by firm	Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.	474 units

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.