Arcos Modular Revision System
48 catalogue numbers from 31-301824, listed by Biomet Orthopedics, United States, under Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish. 7 manufacturers in China are registered for this product code.
7manufacturers in China registered for this device type
48catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (4), Shanghai (2), Zhejiang (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| APS Materials Suzhou | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Lincotek (Wuxi) Co., Ltd. | Wuxi | Jiangsu | 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 |
Record
| Listed by | Biomet Orthopedics, United States |
|---|---|
| FDA product code | MAY |
| Device type | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3353 |
| 510(k) | K090757 |
| Record published | 2016-10-21 |
| 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 |
|---|---|---|
| 31-301824 | 18.5MM | In distribution |
| 31-301352 | 80 mm Size B | In distribution |
| 31-301613 | 13 mm X 200 mm | In distribution |
| 31-301102 | SIZE B | In distribution |
| 31-302026 | 26MM X 300MM | In distribution |
| 31-301115 | In distribution | |
| 31-301114 | In distribution | |
| 31-301322 | SIZE B 70MM STANDARD OFFSET | In distribution |
| 31-301822 | 17.5 mm | In distribution |
| 31-301336 | Size F 70 mm | In distribution |
| 31-300829 | 29MM X 150MM | In distribution |
| 31-300828 | 28MM X 150MM | In distribution |
| 31-302000 | In distribution | |
| 31-301725 | 25 mm X 250 mm | In distribution |
| 31-301833 | 23MM | In distribution |
| 31-301726 | 26MM X 250MM | In distribution |
| 110018392 | SIZE E | In distribution |
| 31-301621 | 21MM X 200MM | In distribution |
| 31-301105 | Size E 60 mm | In distribution |
| 31-301830 | 21.5 mm | In distribution |
| 31-311302 | Size B / 60 mm / | In distribution |
| 31-301123 | SIZE EF | In distribution |
| 31-301336 | SIZE F 70MM HIGH OFFSET | In distribution |
| 31-301315 | SIZE E 60MM HIGH OFFSET | In distribution |
| 31-301365 | Size E | In distribution |
| 31-301110 | Small | In distribution |
| 31-301354 | SIZE D 80MM HIGH OFFSET | In distribution |
| 31-301612 | 12MM X 200MM | In distribution |
| 31-301827 | 20MM | In distribution |
| 31-301314 | SIZE D 60MM HIGH OFFSET | In distribution |
| 31-311325 | Size E / 70 mm / | In distribution |
| 31-301850 | 55 INCH-POUNDS | In distribution |
| 31-301520 | 20MM X 150MM | In distribution |
| 31-301816 | 14.5MM | In distribution |
| 31-311335 | Size E / 70 mm / | In distribution |
| 31-301621 | 21 mm X 200 mm | In distribution |
| 31-300576 | Size 26 | In distribution |
| 31-301619 | 19 mm X 200 mm | In distribution |
| 31-302023 | 23MM X 300MM | In distribution |
| 31-300863 | 13MM X 150/250MM | In distribution |
| 31-301210 | 50 mm Size A | In distribution |
| 31-301421 | 21 mm X 115 mm | In distribution |
| 31-301851 | In distribution | |
| 31-301613 | 13MM X 200MM | In distribution |
| 31-300869 | 19MM X 150/250MM | In distribution |
| 31-301301 | SIZE A 60MM STANDARD OFFSET | In distribution |
| 31-301322 | 70 mm Size B | In distribution |
| 31-311351 | Size A / 80 mm / | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Instrument | Howmedica Osteonics Corp | 136 |
| Arcos Modular Revision Hip System | Biomet Orthopedics | 40 |
| Ringloc HIP System | Biomet Orthopedics | 36 |
| Restoration | Howmedica Osteonics Corp | 29 |
| Arcos | Biomet Orthopedics | 19 |
| Echo® Bi-Metric® Hip System | Biomet Orthopedics | 18 |
| Trident | Howmedica Osteonics Corp | 12 |
| Arcos® STS™ Modular Revision System | Biomet Orthopedics | 10 |
| Ringloc Ranawat / Burstein HIP System | Biomet Orthopedics | 10 |
| OrthoMedFlex | Orthomedflex LLC | 10 |
| Taperloc Complete Rasp/Provisional | Biomet Orthopedics | 9 |
| Regenerex® Ringloc®+ Hip System | Biomet Orthopedics | 9 |
Showing 12 of 40. All products under Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish
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.