Orthopedic › ProstheticProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate

Arcos Modular Revision Hip System

44 catalogue numbers from 11-301925, listed by Biomet Orthopedics, United States, under Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate. 14 manufacturers in China are registered for this product code.

Registry build 21.09.26
14manufacturers in China registered for this device type
44catalogue numbers in this listing
2510(k) clearances naming this product code

Who Else Makes It

Concentrated in Jiangsu (8), Shanghai (2), Zhejiang (2). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code MEH
Manufacturer City Province Registered as Device types
Canwell Medical Co., Ltd. Jinhua Zhejiang Contract manufacturer 42
Suzhou Elite Precision Machinery Co., Ltd. Kunshan Jiangsu Contract manufacturer 35
B-ONE Medical (Suzhou) Co., Ltd. Suzhou Jiangsu Contract manufacturer 23
Stryker (Suzhou) Medical Technology Co., Ltd. Suzhou Jiangsu Contract manufacturer 19
APS Materials Suzhou Suzhou Jiangsu Contract manufacturer 18
Xian Airfoil Technology Co., Ltd. Xian Shaanxi Contract manufacturer 8
Lincotek (Wuxi) Co., Ltd. Wuxi Jiangsu Contract manufacturer 7
b-ONE Medical (Beijing) Co., Ltd. Beijing Beijing Contract manufacturer 7
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

Showing 12 of 14. All 14 manufacturers in China registered for Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate

Record

Regulatory record for Arcos Modular Revision Hip System
Listed by Biomet Orthopedics, United States
FDA product code MEH
Device type Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Device class Class 2
Regulation 21 CFR 888.3353
510(k) K100469
Record published 2015-10-24
Record revised 2025-05-30 (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

Catalogue Numbers

Catalogue numbers for Arcos Modular Revision Hip System
Catalogue number Size Status
11-301925 25 MM 250 MM In distribution
11-301028 28 MM 250 MM In distribution
11-300723 23 MM 250 MM In distribution
11-301620 20 MM 200 MM In distribution
11-300818 18 MM 150 MM In distribution
11-302125 25 MM In distribution
11-300612 12 MM 200 MM In distribution
11-300812 12 MM 150 MM In distribution
11-301326 F SIZE 70 MM TYPE I TAPER In distribution
11-302154 54 MM In distribution
11-300813 13 MM 150 MM In distribution
11-300622 22 MM 200 MM In distribution
11-301412 12 MM 115 MM In distribution
11-301725 25 MM 250 MM In distribution
11-301212 B SIZE 60 MM TYPE 1 TAPER In distribution
11-301415 15 MM 115 MM In distribution
11-302020 20 MM 300 MM In distribution
11-301718 18 MM 250 MM In distribution
11-301204 D SIZE 60 MM TYPE I TAPER In distribution
11-301518 18 MM 150 MM In distribution
11-301815 15 MM 200 MM In distribution
11-301345 E SIZE 80 MM TYPE I TAPER In distribution
11-301826 26 MM 200 MM In distribution
11-301201 A SIZE 60 MM TYPE I TAPER In distribution
11-302145 45 MM In distribution
11-300617 17 MM 200 MM In distribution
11-301029 29 MM 250 MM In distribution
11-301420 20 MM 115 MM In distribution
11-300815 15 MM 150 MM In distribution
11-300921 21 MM 190 MM In distribution
11-301316 F SIZE 60 MM TYPE 1 TAPER In distribution
11-301825 25 MM 200 MM In distribution
11-301916 16 MM 250 MM In distribution
11-300726 26 MM 250 MM In distribution
11-301242 B SIZE 60 MM TYPE I TAPER In distribution
11-300928 28 MM 190 MM In distribution
11-301621 21 MM 200 MM In distribution
11-301923 23 MM 250 MM In distribution
11-301322 B SIZE 70 MM TYPE I TAPER In distribution
11-301332 B SIZE 70 MM TYPE 1 TAPER In distribution
11-302129 29 MM In distribution
11-302127 27 MM In distribution
11-301027 27 MM 250 MM In distribution
11-301715 15 MM 250 MM In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Alteon Exactech, Inc. 326
Novation Exactech, Inc. 317
Pinnacle Depuy Orthopaedics, Inc. 305
SP-CL Hip Stem Waldemar Link GmbH & Co. KG 219
Emperion Smith & Nephew, Inc. 201
MobileLink Acetabular Cup System Waldemar Link GmbH & Co. KG 154
Instrument Howmedica Osteonics Corp 145
Restoration Howmedica Osteonics Corp 144
Mfinity Femoral System Medacta International SA 138
Echelon Smith & Nephew, Inc. 134
Trinity Acetabular Hip System Corin Limited 128
Redapt Smith & Nephew, Inc. 127

Showing 12 of 805. All products under Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K021403 2002-05-31
K020963 2002-04-16

Recalls Naming This Product

2 recalls name this product by its own identifiers, the UDI on its label or the 510(k) it is cleared under.

Recalls naming the identifiers of Arcos Modular Revision Hip System
Recalled by Identified by Initiated FDA class Root cause Reason Quantity Closed
Biomet, Inc. UDI-DI 2021-06-02 Class II Process control Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion
and device failure in vivo leading to surgical intervention		 11 units 2022-07-06
Biomet, Inc. 510(k) number 2018-06-08 Class II Process control Two lots of the Echo BI-Metric Hip Stem and ARCOS Modular Revision Hip Stem may have been comingled. Potential health consequences include extension of surgery time to find a replacement component. 12 2020-04-14

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