Arcos® Modular Revision System
69 catalogue numbers from 31-301301, 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.
14manufacturers in China registered for this device type
69catalogue 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.
| 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
| 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 | 2022-05-08 |
| Record revised | 2025-05-30 (version 7) |
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 |
|---|---|---|
| 31-301301 | 60 mm Size A | In distribution |
| 31-301713 | 13 mm X 250 mm | In distribution |
| 31-301337 | 70 mm Size G | In distribution |
| 31-301517 | 17 mm X 150 mm | In distribution |
| 31-311341 | Size A / 80 mm / | In distribution |
| 31-301825 | 19MM | In distribution |
| 31-301812 | 12.5MM | In distribution |
| 110018392 | Size E | In distribution |
| 31-301714 | 14 mm X 250 mm | In distribution |
| 31-311321 | Size A / 70 mm / | In distribution |
| 31-301724 | 24 mm X 250 mm | In distribution |
| 31-301341 | SIZE A 80MM STANDARD OFFSET | In distribution |
| 31-301115 | In distribution | |
| 31-301103 | Size C 60 mm | In distribution |
| 31-301811 | 12 mm | In distribution |
| 31-301332 | 70 mm Size B | In distribution |
| 31-301717 | 17MM X 250MM | In distribution |
| 31-301312 | 60 mm Size B | In distribution |
| 31-301515 | 15 mm X 150 mm | In distribution |
| 31-302024 | 24MM X 300MM | In distribution |
| 31-301307 | Size G 60 mm | In distribution |
| 31-301104 | SIZE D | In distribution |
| 31-301853 | 5.0 MM | In distribution |
| 31-301518 | 18 mm X 150 mm | In distribution |
| 31-301525 | 25 mm X 150 mm | In distribution |
| 31-301107 | In distribution | |
| 31-311332 | Size B / 70 mm / | In distribution |
| 31-301316 | Size F 60 mm | In distribution |
| 31-301625 | 25MM X 200MM | In distribution |
| 31-301623 | 23 mm X 200 mm | In distribution |
| 31-311312 | Size B / 60 mm / | In distribution |
| 31-301357 | SIZE G 80MM HIGH OFFSET | In distribution |
| 31-301356 | 80 mm Size F | In distribution |
| 31-301331 | SIZE A 70MM HIGH OFFSET | In distribution |
| 31-300877 | 27MM X 150/250MM | In distribution |
| 31-301347 | 80 mm Size G | In distribution |
| 31-301614 | 14MM X 200MM | In distribution |
| 31-301420 | 20 mm X 115 mm | In distribution |
| 31-300977 | 27MM X 190MM | In distribution |
| 31-301109 | Large | In distribution |
| 31-301843 | 28MM | In distribution |
| 31-311327 | SIZE G 70MM STANDARD OFFSET | In distribution |
| 31-301524 | 24MM X 150MM | In distribution |
| 31-301326 | 70 mm Size F | In distribution |
| 31-300571 | SIZE 21 | In distribution |
| 31-300865 | 15MM X 150/250MM | In distribution |
| 31-300871 | 21MM X 150/250MM | In distribution |
| 31-301323 | 70 mm Size C | In distribution |
| 31-311317 | SIZE G 60MM HIGH OFFSET | In distribution |
| 31-311347 | SIZE G 80MM STANDARD OFFSET | In distribution |
| 31-301834 | 23.5MM | In distribution |
| 31-301717 | 17 mm X 250 mm | In distribution |
| 31-300576 | SIZE 26 | In distribution |
| 31-301614 | 14 mm X 200 mm | In distribution |
| 31-311310 | Size A / 50 mm / | In distribution |
| 31-311352 | Size B / 80 mm / | In distribution |
| 31-301820 | 16.5MM | In distribution |
| 31-301111 | Size A | In distribution |
| 31-301723 | 23MM X 250MM | In distribution |
| 31-301341 | 80 mm Size A | In distribution |
| 31-301824 | 18.5 mm | In distribution |
| 31-301808 | 10.5MM | In distribution |
| 31-301112 | Size B/C/D | In distribution |
| 31-301838 | 25.5MM | In distribution |
| 31-301342 | SIZE B 80MM STANDARD OFFSET | In distribution |
| 31-301823 | 18 mm | In distribution |
| 31-301615 | 15MM X 200MM | In distribution |
| 31-301716 | 16 mm X 250 mm | In distribution |
| 31-311305 | Size E / 60 mm / | In distribution |
Same 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
| Clearance | Decision date |
|---|---|
| K021403 | 2002-05-31 |
| K020963 | 2002-04-16 |
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.