Who else makes this device?

Name: Chisel
Brand: Chisel

Orthopedic › ProstheticProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

Chisel

Catalogue number 261103, listed by Fournitures Hospitalieres Industrie, United States, under Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented. 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). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code KWS
Manufacturer	City	Province	Registered as	Device types
Paragon Medical Device (Changzhou) Co., Ltd.	Changzhou	Jiangsu	Contract manufacturer	53
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

Record

Regulatory record for Chisel
Listed by	Fournitures Hospitalieres Industrie, United States
FDA product code	KWS
Device type	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Device class	Class 2
Regulation	21 CFR 888.3660
510(k)	K093599
Record published	2019-03-13
Record revised	2023-05-03 (version 2)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Sterilisation	Moist Heat or Steam Sterilization
Label carries	lot or batch number, manufacturing date

Catalogue Numbers

Catalogue numbers for Chisel
Catalogue number	Size	Status
261103		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Equinoxe	Exactech, Inc.	442
Reunion	Stryker GmbH	321
DJO Surgical	Encore Medical, L.P.	266
SMR Shoulder	Limacorporate	209
Tornier Flex Shoulder System	Tornier Inc.	187
Anatomical Shoulder™	Zimmer, Inc.	166
Arthrex®	Arthrex, Inc.	154
Comprehensive Shoulder System	Biomet Orthopedics	111
Flex Shoulder System	Tornier Inc.	109
Aequalis™ PerFORM+	Tornier Inc.	108
Aequalis™ Ascend™ Flex	Tornier Inc.	102
Anatomic Shoulder Prosthesis	Medacta International SA	90

Showing 12 of 326. All products under Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K093599	2010-11-24

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.