Arcos Modular Revision System
Calcar Body Trial - Basic, Size A 50MM +0 Standard Offset
13manufacturers in China registered for this device type
72catalogue 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.
| 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
| 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) | K090757 |
| Record published | 2016-10-21 |
| 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 |
|---|---|---|
| 31-311326 | SIZE F 70MM STANDARD OFFSET | In distribution |
| 31-311355 | Size E / 80 mm / | In distribution |
| 31-301832 | 22.5MM | In distribution |
| 31-301315 | 60 mm Size E | In distribution |
| 31-311324 | Size D / 70 mm / | In distribution |
| 31-301310 | SIZE A 50MM HIGH OFFSET | In distribution |
| 31-301809 | 11MM | In distribution |
| 31-301342 | 80 mm Size B | In distribution |
| 31-301617 | 17 mm X 200 mm | In distribution |
| 31-301101 | SIZE A | In distribution |
| 31-300975 | 25MM X 190MM | In distribution |
| 31-301623 | 23MM X 200MM | In distribution |
| 110018389 | SIZE B | In distribution |
| 31-300972 | 22MM X 190MM | In distribution |
| 31-301305 | 60 mm Size E | In distribution |
| 31-301361 | SIZE A | In distribution |
| 31-300572 | SIZE 22 | In distribution |
| 31-311315 | Size E / 60 mm / | In distribution |
| 31-301114 | In distribution | |
| 31-311337 | SIZE G 70MM HIGH OFFSET | In distribution |
| 31-301724 | 24MM X 250MM | In distribution |
| 31-301712 | 12MM X 250MM | In distribution |
| 31-301805 | 9 mm | In distribution |
| 31-300569 | Size 19 | In distribution |
| 31-301523 | 23MM X 150MM | In distribution |
| 31-300878 | 28MM X 150/250MM | In distribution |
| 31-301000 | In distribution | |
| 31-301829 | 21MM | In distribution |
| 31-301354 | 80 mm Size D | In distribution |
| 31-301325 | 70 mm Size E | In distribution |
| 31-300962 | 12MM X 190MM | In distribution |
| 31-301521 | 21 mm X 150 mm | In distribution |
| 31-311304 | Size D / 60 mm / | In distribution |
| 31-311303 | Size C / 60 mm / | In distribution |
| 31-301344 | SIZE D 80MM STANDARD OFFSET | In distribution |
| 31-302022 | 22 mm X 300 mm | In distribution |
| 31-301513 | 13MM X 150MM | In distribution |
| 31-311210 | SIZE A 50MM +0 HIGH OFFSET | In distribution |
| 31-301367 | Size G | In distribution |
| 31-301811 | 12MM | In distribution |
| 31-301835 | 24 mm | In distribution |
| 31-301854 | In distribution | |
| 31-301314 | 60 mm Size D | In distribution |
| 31-301836 | 24.5MM | In distribution |
| 31-301807 | 10MM | In distribution |
| 31-300872 | 22MM X 150/250MM | In distribution |
| 31-301615 | 15 mm X 200 mm | In distribution |
| 31-301802 | 7.5 mm | In distribution |
| 31-301361 | Size A | In distribution |
| 31-301422 | 22 mm X 115 mm | In distribution |
| 31-301121 | SIZE A | In distribution |
| 31-301317 | Size G 60 mm | In distribution |
| 31-302022 | 22MM X 300MM | In distribution |
| 31-301363 | Size C | In distribution |
| 31-301415 | 15 mm X 115 mm | In distribution |
| 31-301843 | 28 mm | In distribution |
| 31-311200 | SIZE A 50MM +0 STANDARD OFFSET | In distribution |
| 31-301616 | 16MM X 200MM | In distribution |
| 31-301626 | 26MM X 200MM | In distribution |
| 31-300566 | Size 16 | In distribution |
| 31-300879 | 29MM X 150/250MM | In distribution |
| 31-301324 | SIZE D 70MM STANDARD OFFSET | In distribution |
| 31-301313 | 60 mm Size C | In distribution |
| 31-301368 | In distribution | |
| 31-301344 | 80 mm Size D | In distribution |
| 31-302001 | In distribution | |
| 31-301617 | 17MM X 200MM | In distribution |
| 31-301121 | Size A | In distribution |
| 31-301835 | 24MM | In distribution |
| 31-300873 | 23MM X 150/250MM | In distribution |
| 31-300574 | SIZE 24 | In distribution |
| 31-301522 | 22 mm X 150 mm | In distribution |
Same 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
| Clearance | Decision date |
|---|---|
| K253515 | 2026-08-24 |
| K023085 | 2002-10-17 |
| K020076 | 2002-01-30 |
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.