TaperSet™ Hip System

Femoral Stem, Standard, Cementless, PC, Plasma

Registry build 21.09.26
10manufacturers in China registered for this device type
24catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (4), Shanghai (3), Zhejiang (2). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code KWL
Manufacturer City Province Registered as Device types
MicroPort Orthopedics Global Supply Center Limited Shanghai Shanghai Contract manufacturer 82
Zhejiang Biomet Medical Products Co., Ltd. Jinhua Zhejiang Contract manufacturer 74
Canwell Medical Co., Ltd. Jinhua Zhejiang Contract manufacturer 42
Suzhou Elite Precision Machinery Co., Ltd. Kunshan Jiangsu Contract manufacturer 35
Stryker (Suzhou) Medical Technology Co., Ltd. Suzhou Jiangsu Contract manufacturer 19
Xian Airfoil Technology Co., Ltd. Xian Shaanxi Contract manufacturer 8
Zimmer (Shanghai) Medical International Trading Co., Ltd. Shanghai Shanghai Exporter 106
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 TaperSet™ Hip System
Listed by Consensus Orthopedics, Inc., United States
FDA product code KWL
Device type Prosthesis, Hip, Hemi-, Femoral, Metal
Device class Class 2
Regulation 21 CFR 888.3360
Record published 2015-10-24
Record revised 2021-07-29 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Latex Labelled latex-free
Label carries lot or batch number, expiry date
Sizes Outer diameter 5 to 24 mm
Distribution end date 2021-07-28
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for TaperSet™ Hip System
Catalogue number Size Status
1210-0-0185 Outer Diameter 18.5 mm Withdrawn
1211-0-0185 Outer Diameter 18.5 mm Withdrawn
1211-0-0060 Outer Diameter 6 mm Withdrawn
1210-0-0050 Outer Diameter 5 mm Withdrawn
1210-0-0165 Outer Diameter 16.5 mm Withdrawn
1210-0-0135 Outer Diameter 13.5 mm Withdrawn
1211-0-0210 Outer Diameter 21 mm Withdrawn
1211-0-0240 Outer Diameter 24 mm Withdrawn
1210-0-0075 Outer Diameter 7.5 mm Withdrawn
1210-0-0120 Outer Diameter 12 mm Withdrawn
1211-0-0075 Outer Diameter 7.5 mm Withdrawn
1210-0-0150 Outer Diameter 15 mm Withdrawn
1210-0-0210 Outer Diameter 21 mm Withdrawn
1210-0-0090 Outer Diameter 9 mm Withdrawn
1211-0-0120 Outer Diameter 12 mm Withdrawn
1210-0-0060 Outer Diameter 6 mm Withdrawn
1211-0-0105 Outer Diameter 10.5 mm Withdrawn
1211-0-0050 Outer Diameter 5 mm Withdrawn
1211-0-0135 Outer Diameter 13.5 mm Withdrawn
1210-0-0105 Outer Diameter 10.5 mm Withdrawn
1211-0-0150 Outer Diameter 15 mm Withdrawn
1211-0-0090 Outer Diameter 9 mm Withdrawn
1210-0-0240 Outer Diameter 24 mm Withdrawn
1211-0-0165 Outer Diameter 16.5 mm Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Ustar II Knee System United Orthopedic Corp. 115
Consensus Hip System Shalby Advanced Technologies, Inc. 95
Consensus® Hip System Consensus Orthopedics, Inc. 95
Instrument Howmedica Osteonics Corp 94
UHR Howmedica Osteonics Corp 75
Austin Moore Howmedica Osteonics Corp 67
B-P Total HIP System Endotec, Inc. 66
CS2 Acetabular Cup System Consensus Orthopedics, Inc. 64
DJO Surgical Encore Medical, L.P. 62
Restoration Howmedica Osteonics Corp 56
Optimom Modular Heads Corin Limited 49
Corin Unipolar Modular Head Corin Limited 36

Showing 12 of 167. All products under Prosthesis, Hip, Hemi-, Femoral, Metal

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer