Who else makes this device?

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

B-P Total Shoulder System · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented → Orthopedic

6manufacturers in China registered for this device type

8catalogue numbers in this listing

1510(k) clearance

Who Else Makes It

Concentrated in Jiangsu (3), Shanghai (2), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code KWT
Manufacturer	City	Province	Registered as	Device types
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
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	KWT
Device type	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
Device class	Class 2
Regulation	21 CFR 888.3650
510(k)	K982418
Record published	2015-09-17
Record revised	2024-03-15 (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 8 to 14 mm
Distribution end date	2024-03-04

Catalogue Numbers

Catalogue numbers for B-P Total Shoulder System
Catalogue number	Size	Status
02-04-0608	Outer Diameter 8 mm	In distribution
02-21-0201	SIZE 1	In distribution
02-04-0614	Outer Diameter 14 mm	In distribution
02-04-0610	Outer Diameter 10 mm	In distribution
02-21-0204	SIZE 4	In distribution
02-04-0612	Outer Diameter 12 mm	In distribution
02-21-0202	SIZE 2	In distribution
02-21-0203	SIZE 3	Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Equinoxe	Exactech, Inc.	336
SMR Shoulder	Limacorporate	289
Tornier Perform Humeral System	Tornier Inc.	119
Bigliani/Flatow®	Zimmer, Inc.	119
Trabecular Metal®	Zimmer, Inc.	115
Jarvis Glenoid Rerverse Shoulder Prosthesis	Fournitures Hospitalieres Industrie	103
Comprehensive® Shoulder System	Biomet Orthopedics	86
Alliance®	Zimmer, Inc.	68
Anatomical Shoulder™	Zimmer, Inc.	54
Aetos Shoulder System	Smith & Nephew, Inc.	53
Perform™ Humeral System	Tornier Inc.	47
Bio-Modular® Shoulder System	Biomet Orthopedics	43

Showing 12 of 164. All products under Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K960424	1996-08-26

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