Arcos® Modular Revision System
67 catalogue numbers from 31-301327, listed by Biomet Orthopedics, United States, under Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented. 14 manufacturers in China are registered for this product code.
14manufacturers in China registered for this device type
67catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (7), Shanghai (3), Zhejiang (2). 9 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| 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 |
Showing 12 of 14. All 14 manufacturers in China registered for Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Record
| Listed by | Biomet Orthopedics, United States |
|---|---|
| FDA product code | KWY |
| Device type | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3390 |
| 510(k) | K100469 |
| Record published | 2022-05-08 |
| Record revised | 2025-05-30 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 31-301327 | 70 mm Size G | In distribution |
| 31-300963 | 13MM X 190MM | In distribution |
| 31-302026 | 26 mm X 300 mm | In distribution |
| 31-301819 | 16 mm | In distribution |
| 31-301523 | 23 mm X 150 mm | In distribution |
| 31-301715 | 15MM X 250MM | In distribution |
| 31-301620 | 20 mm X 200 mm | In distribution |
| 31-301353 | 80 mm Size C | In distribution |
| 31-301343 | 80 mm Size C | In distribution |
| 31-302021 | 21 mm X 300 mm | In distribution |
| 31-301817 | 15 mm | In distribution |
| 31-301101 | 60 mm Size A | In distribution |
| 31-301519 | 19 mm X 150 mm | In distribution |
| 31-301725 | 25MM X 250MM | In distribution |
| 31-311322 | Size B / 70 mm / | In distribution |
| 31-301418 | 18 mm X 115 mm | In distribution |
| 31-301416 | 16 mm X 115 mm | In distribution |
| 31-301807 | 10 mm | In distribution |
| 31-301412 | 12 mm X 115 mm | In distribution |
| 31-301721 | 21 mm X 250 mm | In distribution |
| 31-302001 | In distribution | |
| 31-301716 | 16MM X 250MM | In distribution |
| 31-301303 | SIZE C 60MM STANDARD OFFSET | In distribution |
| 31-300928 | 28MM X 190MM | In distribution |
| 31-300564 | Size 14 | In distribution |
| 31-301122 | Size B/C/D | In distribution |
| 31-301334 | 70 mm Size D | In distribution |
| 31-311307 | SIZE G 60MM STANDARD OFFSET | In distribution |
| 31-300968 | 18MM X 190MM | In distribution |
| 31-301830 | 21.5MM | In distribution |
| 31-301005 | RIGHT POSTERIOR / LEFT ANTERIOR | In distribution |
| 31-301712 | 12 mm X 250 mm | In distribution |
| 31-301110 | SMALL | In distribution |
| 31-301327 | SIZE G 70MM STANDARD OFFSET | In distribution |
| 31-300870 | 20MM X 150/250MM | In distribution |
| 31-300876 | 26MM X 150/250MM | In distribution |
| 31-300971 | 21MM X 190MM | In distribution |
| 31-301722 | 22MM X 250MM | In distribution |
| 31-301714 | 14MM X 250MM | In distribution |
| 31-301353 | SIZE C 80MM HIGH OFFSET | In distribution |
| 31-301312 | SIZE B 60MM HIGH OFFSET | In distribution |
| 31-300874 | 24MM X 150/250MM | In distribution |
| 31-311356 | SIZE F 80MM HIGH OFFSET | In distribution |
| 31-301810 | 11.5MM | In distribution |
| 31-301836 | 24.5 mm | In distribution |
| 31-301616 | 16 mm X 200 mm | In distribution |
| 31-301723 | 23 mm X 250 mm | In distribution |
| 31-301831 | 22 mm | In distribution |
| 110018391 | Size D | In distribution |
| 31-301302 | 60 mm Size B | In distribution |
| 31-301833 | 23 mm | In distribution |
| 31-301332 | SIZE B 70MM HIGH OFFSET | In distribution |
| 110018393 | SIZE F | In distribution |
| 31-301300 | SIZE A 50MM STANDARD OFFSET | In distribution |
| 31-301823 | 18MM | In distribution |
| 31-300965 | 15MM X 190MM | In distribution |
| 31-300565 | Size 15 | In distribution |
| 31-301345 | 80 mm Size E | In distribution |
| 31-300573 | Size 23 | In distribution |
| 31-301321 | SIZE A 70MM STANDARD OFFSET | In distribution |
| 31-301803 | 8 mm | In distribution |
| 31-301413 | 13 mm X 115 mm | In distribution |
| 31-301719 | 19MM X 250MM | In distribution |
| 31-300562 | Size 12 | In distribution |
| 31-300827 | 27MM X 150MM | In distribution |
| 31-301514 | 14MM X 150MM | In distribution |
| 31-311357 | SIZE G 80MM HIGH OFFSET | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Resolve Modular Revision Hip Stem | United Orthopedic Corp. | 196 |
| Corin Bipolar Prosthesis | Corin Limited | 182 |
| Consensus® Hip System | Consensus Orthopedics, Inc. | 177 |
| Consensus Hip System | Shalby Advanced Technologies, Inc. | 177 |
| Instrument | Howmedica Osteonics Corp | 130 |
| Bencox Hip System | Corentec Co., Ltd. | 126 |
| United Hip System, U2 Bipolar Implant | United Orthopedic Corp. | 123 |
| MultiPolar® | Zimmer, Inc. | 100 |
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | Zimmer, Inc. | 96 |
| Fitmore® Hip Stem | Zimmer, Inc. | 75 |
| Acumatch L-Series | Exactech, Inc. | 67 |
| Corin BiPolar-i | Corin Limited | 54 |
Showing 12 of 352. All products under Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| 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.