Arcos® Modular Revision System
69 catalogue numbers from 31-301827, listed by Biomet Orthopedics, United States, under Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented. 15 manufacturers in China are registered for this product code.
15manufacturers in China registered for this device type
69catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (8), Shanghai (3), Zhejiang (2). 10 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 |
| 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 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
Showing 12 of 15. All 15 manufacturers in China registered for Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Record
| Listed by | Biomet Orthopedics, United States |
|---|---|
| FDA product code | LZO |
| Device type | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3353 |
| 510(k) | K090757 |
| Record published | 2022-04-02 |
| 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 |
|---|---|---|
| 31-301827 | 20 mm | In distribution |
| 31-301522 | 22MM X 150MM | In distribution |
| 31-301831 | 22MM | In distribution |
| 31-301825 | 19 mm | In distribution |
| 31-301517 | 17MM X 150MM | In distribution |
| 31-311323 | Size C / 70 mm / | In distribution |
| 31-301414 | 14 mm X 115 mm | In distribution |
| 31-301720 | 20 mm X 250 mm | In distribution |
| 31-302025 | 25 mm X 300 mm | In distribution |
| 31-301512 | 12 mm X 150 mm | In distribution |
| 31-301806 | 9.5 mm | In distribution |
| 31-301819 | 16MM | In distribution |
| 31-301804 | 8.5 mm | In distribution |
| 31-301417 | 17 mm X 115 mm | In distribution |
| 31-301520 | 20 mm X 150 mm | In distribution |
| 31-311344 | Size D / 80 mm / | In distribution |
| 31-311353 | Size C / 80 mm / | In distribution |
| 31-301516 | 16 mm X 150 mm | In distribution |
| 110018390 | Size C | In distribution |
| 31-301816 | 14.5 mm | In distribution |
| 31-301335 | 70 mm Size E | In distribution |
| 31-301852 | 3.5 mm | In distribution |
| 31-300973 | 23MM X 190MM | In distribution |
| 31-311345 | Size E / 80 mm / | In distribution |
| 31-300864 | 14MM X 150/250MM | In distribution |
| 31-301300 | 50 mm Size A | In distribution |
| 31-301832 | 22.5 mm | In distribution |
| 31-301822 | 17.5MM | In distribution |
| 31-300970 | 20MM X 190MM | In distribution |
| 31-301104 | Size D 60 mm | In distribution |
| 31-301803 | 8MM | In distribution |
| 31-302021 | 21MM X 300MM | In distribution |
| 31-301311 | 60 mm Size A | In distribution |
| 31-301366 | Size F | In distribution |
| 110018393 | Size F | In distribution |
| 31-300867 | 17MM X 150/250MM | In distribution |
| 31-301123 | Size E/F | In distribution |
| 31-301331 | 70 mm Size A | In distribution |
| 31-301813 | 13 mm | In distribution |
| 31-301850 | In distribution | |
| 31-300866 | 16MM X 150/250MM | In distribution |
| 31-301351 | SIZE A 80MM HIGH OFFSET | In distribution |
| 31-302000 | In distribution | |
| 31-302003 | 3/8″ | In distribution |
| 31-311331 | Size A / 70 mm / | In distribution |
| 31-301316 | SIZE F 60MM HIGH OFFSET | In distribution |
| 31-301837 | 25 mm | In distribution |
| 110018394 | Size G | In distribution |
| 31-300567 | Size 17 | In distribution |
| 31-301005 | In distribution | |
| 31-301805 | 9MM | In distribution |
| 31-311314 | Size D / 60 mm / | In distribution |
| 31-301834 | 23.5 mm | In distribution |
| 31-300969 | 19MM X 190MM | In distribution |
| 31-300575 | Size 25 | In distribution |
| 31-300868 | 18MM X 150/250MM | In distribution |
| 31-301335 | SIZE E 70MM HIGH OFFSET | In distribution |
| 31-301518 | 18MM X 150MM | In distribution |
| 31-301303 | 60 mm Size C | In distribution |
| 110018388 | SIZE A | In distribution |
| 31-311306 | SIZE F 60MM STANDARD OFFSET | In distribution |
| 31-300570 | Size 20 | In distribution |
| 31-311333 | Size C / 70 mm / | In distribution |
| 31-300974 | 24MM X 190MM | In distribution |
| 31-302025 | 25MM X 300MM | In distribution |
| 31-301514 | 14 mm X 150 mm | In distribution |
| 31-301842 | 27.5 mm | In distribution |
| 31-301516 | 16MM X 150MM | In distribution |
| 31-311313 | Size C / 60 mm / | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Libertas | Maxx Orthopedics Inc. | 1,832 |
| Redapt | Smith & Nephew, Inc. | 326 |
| Bencox Hip System | Corentec Co., Ltd. | 295 |
| M-Vizion Femoral Revision System | Medacta International SA | 289 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Zimmer, Inc. | 280 |
| Profemur® | Microport Orthopedics Inc. | 229 |
| DJO Surgical | Encore Medical, L.P. | 162 |
| Instrument | Howmedica Osteonics Corp | 152 |
| Alteon | Exactech, Inc. | 151 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Exactech, Inc. | 136 |
| Resolve Modular Revision Hip Stem | United Orthopedic Corp. | 136 |
| Wagner SL Revision® | Zimmer, Inc. | 133 |
Showing 12 of 691. All products under Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K200196 | 2020-12-08 |
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.