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

Arcos Modular Revision Hip System

41 catalogue numbers from 11-301336, listed by Biomet Orthopedics, United States, under Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented. 13 manufacturers in China are registered for this product code.

Registry build 21.09.26
13manufacturers in China registered for this device type
41catalogue numbers in this listing
3510(k) clearances naming this product code

Who Else Makes It

Concentrated in Jiangsu (6), Shanghai (3), Zhejiang (2). 9 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code JDI
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
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
b-ONE Medical (Beijing) Co., Ltd. Beijing Beijing Contract manufacturer 7
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

Showing 12 of 13. All 13 manufacturers in China registered for Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

Record

Regulatory record for Arcos Modular Revision Hip System
Listed by Biomet Orthopedics, United States
FDA product code JDI
Device type Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Device class Class 2
Regulation 21 CFR 888.3350
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
11-301336 F SIZE 70 MM TYPE 1 TAPER In distribution
11-300927 27 MM 190 MM In distribution
11-301924 24 MM 250 MM In distribution
11-300525 25 MM 150 MM In distribution
11-300515 15 MM 150 MM In distribution
11-301522 22 MM 150 MM In distribution
11-300926 26 MM 190 MM In distribution
11-301525 25 MM 150 MM In distribution
11-300824 24 MM 150 MM In distribution
11-302137 37 MM In distribution
11-301222 B SIZE 60 MM TYPE I TAPER In distribution
11-301919 19 MM 250 MM In distribution
11-301018 18 MM 250 MM In distribution
11-300913 13 MM 190 MM In distribution
11-301333 C SIZE 70 MM TYPE 1 TAPER In distribution
11-300621 21 MM 200 MM In distribution
11-302140 40 MM In distribution
11-301025 25 MM 250 MM In distribution
11-301823 23 MM 200 MM In distribution
11-301517 17 MM 150 MM In distribution
11-302018 18 MM 300 MM In distribution
11-301344 D SIZE 80 MM TYPE I TAPER In distribution
11-300716 16 MM 250 MM In distribution
11-301026 26 MM 250 MM In distribution
11-300919 19 MM 190 MM In distribution
11-300626 26 MM 200 MM In distribution
11-301015 15 MM 250 MM In distribution
11-301414 14 MM 115 MM In distribution
11-301210 A SIZE 50 MM TYPE 1 TAPER In distribution
11-301317 G SIZE 60 MM TYPE 1 TAPER In distribution
11-301314 D SIZE 60 MM TYPE 1 TAPER In distribution
11-301200 A SIZE 50 MM TYPE I TAPER In distribution
11-301723 23 MM 250 MM In distribution
11-301014 14 MM 250 MM In distribution
11-301102 B SIZE 60 MM TYPE I TAPER In distribution
11-301300 A SIZE 50 MM TYPE I TAPER In distribution
11-301915 15 MM 250 MM In distribution
11-301202 B SIZE 60 MM TYPE I TAPER In distribution
11-301301 A SIZE 60 MM TYPE I TAPER In distribution
11-302152 52 MM In distribution
11-301111 A SIZE 60 MM TYPE 1 TAPER In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Zimmer, Inc. 836
R3 Smith & Nephew, Inc. 497
UniSyn Hip System Shalby Advanced Technologies, Inc. 247
UniSyn® Hip System Consensus Orthopedics, Inc. 247
Reflection Smith & Nephew, Inc. 170
Instrument Howmedica Osteonics Corp 167
Echelon Smith & Nephew, Inc. 159
B-P Total HIP System Endotec, Inc. 151
ZCA® Zimmer, Inc. 149
Omnifit Howmedica Osteonics Corp 149
Ringloc HIP System Biomet Orthopedics 139
Profemur Microport Orthopedics Inc. 113

Showing 12 of 444. All products under Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K253515 2026-08-24
K023085 2002-10-17
K020076 2002-01-30

Recalls Naming This Product

5 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 2022-01-07 Class II Process control The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing indicated that the parts may not have sufficient adhesion strength. The scope was identified to be all lots that were poro 19 units 2023-04-13
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		 88 units 2022-07-06
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		 10 units 2022-07-06
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		 12 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