Arcos® One-Piece Revision System

22 catalogue numbers from 110024884, listed by Biomet Orthopedics, United States, under Prosthesis, Hip, Hemi-, Femoral, Metal. 10 manufacturers in China are registered for this product code.

Registry build 21.09.26
10manufacturers in China registered for this device type
22catalogue 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 Arcos® One-Piece Revision System
Listed by Biomet Orthopedics, United States
FDA product code KWL
Device type Prosthesis, Hip, Hemi-, Femoral, Metal
Device class Class 2
Regulation 21 CFR 888.3360
510(k) K151603
Record published 2022-04-23
Record revised 2025-05-30 (version 5)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date, manufacturing date

Catalogue Numbers

Catalogue numbers for Arcos® One-Piece Revision System
Catalogue number Size Status
110024884 Sizes 15 – 18 In distribution
11-304112 12 MM 210 MM TYPE 1 TAPER In distribution
110024880 In distribution
110024840 In distribution
11-304421 21 MM 210 MM TYPE 1 TAPER In distribution
11-304420 20 MM 210 MM TYPE 1 TAPER In distribution
11-304017 17 MM 175 MM TYPE 1 TAPER In distribution
110024829 14 mm X 175 mm In distribution
110024887 In distribution
11-303026 26 MM 175 MM TYPE 1 TAPER In distribution
11-304011 11 MM 175 MM TYPE 1 TAPER In distribution
11-304014 14 MM 175 MM TYPE 1 TAPER In distribution
11-304416 16 MM 210 MM TYPE 1 TAPER In distribution
11-303013 13 MM 175 MM TYPE 1 TAPER In distribution
110024882 In distribution
11-304118 18 MM 210 MM TYPE 1 TAPER In distribution
11-304425 25 MM 210 MM TYPE 1 TAPER In distribution
11-303000 9.5 MM 175 MM TYPE 1 TAPER In distribution
11-304018 18 MM 175 MM TYPE 1 TAPER In distribution
110024881 Sizes 19 – 26 In distribution
110024843 11 mm X 210 mm In distribution
110024884 In distribution

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