Who else makes this device?

Name: Humelock
Brand: Humelock

Humelock · Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented → Orthopedic

8manufacturers in China registered for this device type

2catalogue numbers in this listing

2510(k) clearances naming this product code

Who Else Makes It

Concentrated in Shanghai (3), Jiangsu (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 HSD
Manufacturer	City	Province	Registered as	Device types
Apex (Guangzhou) Tools & Orthopedics Company	Guangzhou	Guangdong	Contract manufacturer	62
Paragon Medical Device (Changzhou) Co., Ltd.	Changzhou	Jiangsu	Contract manufacturer	53
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

Record

Regulatory record for Humelock
Listed by	Fx Solutions, France
FDA product code	HSD
Device type	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Device class	Class 2
Regulation	21 CFR 888.3690
Record published	2026-06-25

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
Storage	Special storage condition: Store away from light and sunlight Store away from moisture

Catalogue Numbers

Catalogue numbers for Humelock
Catalogue number	Size	Status
903-4036		In distribution
903-4440		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Equinoxe	Exactech, Inc.	345
SMR Shoulder	Limacorporate	182
FX V135	Fx Shoulder Solutions SAS	127
Acumed	Acumed LLC	112
Promos	Smith & Nephew, Inc.	104
Trabecular Metal®	Zimmer, Inc.	90
Bigliani/Flatow®	Zimmer, Inc.	86
Comprehensive® Shoulder System	Biomet Orthopedics	85
Arthrex®	Arthrex, Inc.	75
SMR System	Limacorporate	72
DJO Surgical	Encore Medical, L.P.	70
Humeris Shoulder	Fx Solutions	69

Showing 12 of 241. All products under Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K130759	2013-11-09
K111097	2011-11-09

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.

Humelock