Bencox Mirabo Cup System
Bencox Mirabo is a cementless acetabular cup system for hip replacement. A polyethylene liner provides the bearing surface within the metal cup, supporting metal-on-polyethylene or…
Bencox Mirabo is a cementless acetabular cup system for hip replacement. A polyethylene liner provides the bearing surface within the metal cup, supporting metal-on-polyethylene or ceramic-on-polyethylene articulation.
The cup is titanium alloy with a commercially pure titanium porous coating. A listed polyethylene liner is one component of this cup-and-liner family, with the metal shell providing the surrounding acetabular structure.
Listed Item
Bencox Mirabo PE Liner-10° Elevated type(Type A)
Cup Hole Configurations
The range includes a three-hole cup and a Multi Hole version with 8, 12 or 16 holes. The Multi Hole cup retains the established locking design and compatibility with the system’s cleared polyethylene liners. Hole count is a shell option and does not describe the liner itself.
Who Else Makes It
Concentrated in Jiangsu (7), 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 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| Guangzhou Aquila Precise Tools Limited | Guangzhou | Guangdong | Contract manufacturer | 28 |
| 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 |
| 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 14. All 14 manufacturers in China registered for Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Record
| Listed by | Corentec Co., Ltd., South Korea |
|---|---|
| FDA product code | LPH |
| Device type | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3358 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K182221 |
| Record published | 2019-07-04 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| H3.A15.0074 | In distribution | |
| H3.A15.0048 | In distribution | |
| H1.L61.2835 | In distribution | |
| H3.A15.0066 | In distribution | |
| H1.L61.3239 | In distribution | |
| H3.A15.0052 | In distribution | |
| H3.A15.0064 | In distribution | |
| H3.A15.0054 | In distribution | |
| H3.A15.0070 | In distribution | |
| H1.A11.1044 | In distribution | |
| H3.A15.1056 | In distribution | |
| H3.A15.0060 | In distribution | |
| H3.A15.0046 | In distribution | |
| H1.L67.3239 | In distribution | |
| H1.L66.2835 | In distribution | |
| H3.A15.0072 | In distribution | |
| H1.L66.3239 | In distribution | |
| H3.A15.0058 | In distribution | |
| H3.A15.0068 | In distribution | |
| H3.A15.0056 | In distribution | |
| H3.A15.0062 | In distribution | |
| H3.A15.0044 | In distribution | |
| H3.A15.0050 | In distribution | |
| H1.L67.2835 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Initia Total Hip System | Kyocera Medical Technologies, Inc. | 1,000 |
| DJO Surgical | Encore Medical, L.P. | 624 |
| Pinnacle | Depuy Orthopaedics, Inc. | 613 |
| Trilogy® Longevity® | Zimmer, Inc. | 564 |
| Instrument | Howmedica Osteonics Corp | 369 |
| InSitu Hip System | Nextstep Arthropedix | 368 |
| Trilogy® | Zimmer, Inc. | 359 |
| Kyocera Medical Technologies, Inc. | Kyocera Medical Technologies, Inc. | 298 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Zimmer, Inc. | 286 |
| Bencox Hip System | Corentec Co., Ltd. | 286 |
| OrthoMedFlex | Orthomedflex LLC | 257 |
| Sterizo Total Hip System | CPM Medical Consultants, LLC. | 240 |
Showing 12 of 792. All products under Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K223223 | 2023-02-27 |
| K210614 | 2022-05-24 |
| K220468 | 2022-05-18 |
| K211866 | 2021-07-14 |
| K182221 | 2019-04-01 |
| K172806 | 2017-10-17 |
| K162127 | 2016-12-05 |
| K152084 | 2016-04-29 |
| K150007 | 2015-05-04 |
| K122099 | 2012-10-05 |
| K120924 | 2012-09-10 |
| K103431 | 2011-07-21 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2017-02-27 | Class II | Other | Lot may contain the wrong instruction (Instruction for Chinese customer) instead of correct US instructions for use. | 5 ea | 2017-05-11 |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P880025 | 1991-12-04 | AML(R) POROCOAT(R) ACETABULAR CUP PROSTHESIS | Depuy Intl., Ltd. |
| P880076 | 1991-06-17 | WHITESIDE EPS(TM) FEMORAL HIP PROSTHESIS | Dow Corning Wright |
| P850061 | 1991-03-08 | BIAS(R) FIBER METAL TOTAL HIP SYSTEM | Zimmer, Inc. |
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.