Who else makes this device?

Name: B-P Total Shoulder System
Brand: B-P Total Shoulder System

B-P Total Shoulder System · Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented → Orthopedic

8manufacturers in China registered for this device type

5catalogue numbers in this listing

1510(k) clearance

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 B-P Total Shoulder System
Listed by	Endotec, Inc., United States
FDA product code	HSD
Device type	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Device class	Class 2
Regulation	21 CFR 888.3690
510(k)	K992394
Record published	2015-09-17
Record revised	2024-04-19 (version 6)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date
Storage	Storage environment temperature 5 to 40 °C; Handling environment temperature 5 to 40 °C
Sizes	Outer diameter 40 to 56 mm
Distribution end date	2024-03-04

Catalogue Numbers

Catalogue numbers for B-P Total Shoulder System
Catalogue number	Size	Status
02-03-0048	Outer Diameter 48 mm	In distribution
02-03-0052	Outer Diameter 52 mm	In distribution
02-03-0044	Outer Diameter 44 mm	In distribution
02-03-0040	Outer Diameter 40 mm	Withdrawn
02-03-0056	Outer Diameter 56 mm	Withdrawn

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
K992394	1999-10-15

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.

B-P Total Shoulder System