United Hip System, U2 Bipolar Implant
U2 Bipolar Implant, 28mm I.D., 64mm O.D.
14manufacturers in China registered for this device type
123catalogue numbers in this listing
3510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (7), 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 |
| 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 |
Showing 12 of 14. All 14 manufacturers in China registered for Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Record
| Listed by | United Orthopedic Corp., Taiwan |
|---|---|
| FDA product code | KWY |
| Device type | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3390 |
| Establishment | Contract manufacturer, Manufacturer, Exporter |
| 510(k) | K101670 |
| Record published | 2015-10-24 |
| Record revised | 2020-09-09 (version 6) |
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 |
| Sizes | Lumen/inner diameter 26 to 36 mm; outer diameter 41 to 73 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1503-3164 | Lumen/Inner Diameter 28 mm | In distribution |
| 1503-3665 | Outer Diameter 65 mm | In distribution |
| 1503-3255 | Outer Diameter 55 mm | In distribution |
| 1503-3250 | Lumen/Inner Diameter 32 mm | In distribution |
| 1503-3048 | Lumen/Inner Diameter 26 mm | In distribution |
| 1503-3070 | Lumen/Inner Diameter 26 mm | In distribution |
| 1503-3058 | Lumen/Inner Diameter 26 mm | In distribution |
| 1503-3041 | Outer Diameter 41 mm | In distribution |
| 1503-3158 | Lumen/Inner Diameter 28 mm | In distribution |
| 1503-3062 | Lumen/Inner Diameter 26 mm | In distribution |
| 1503-3660 | Lumen/Inner Diameter 36 mm | In distribution |
| 1503-3161 | Outer Diameter 61 mm | In distribution |
| 1503-3671 | Outer Diameter 71 mm | In distribution |
| 1503-3065 | Outer Diameter 65 mm | In distribution |
| 1503-3652 | Lumen/Inner Diameter 36 mm | In distribution |
| 1503-3046 | Lumen/Inner Diameter 26 mm | In distribution |
| 1503-3165 | Outer Diameter 65 mm | In distribution |
| 1503-3042 | Lumen/Inner Diameter 26 mm | In distribution |
| 1503-3163 | Outer Diameter 63 mm | In distribution |
| 1503-3068 | Lumen/Inner Diameter 26 mm | In distribution |
| 1503-3148 | Lumen/Inner Diameter 28 mm | In distribution |
| 1503-3254 | Lumen/Inner Diameter 32 mm | In distribution |
| 1503-3151 | Outer Diameter 51 mm | In distribution |
| 1503-3149 | Outer Diameter 49 mm | In distribution |
| 1503-3166 | Lumen/Inner Diameter 28 mm | In distribution |
| 1503-3264 | Lumen/Inner Diameter 32 mm | In distribution |
| 1503-3145 | Outer Diameter 45 mm | In distribution |
| 1503-3045 | Outer Diameter 45 mm | In distribution |
| 1503-3050 | Lumen/Inner Diameter 26 mm | In distribution |
| 1503-3657 | Outer Diameter 57 mm | In distribution |
| 1503-3167 | Outer Diameter 67 mm | In distribution |
| 1503-3268 | Lumen/Inner Diameter 32 mm | In distribution |
| 1503-3669 | Outer Diameter 69 mm | In distribution |
| 1503-3651 | Outer Diameter 51 mm | In distribution |
| 1503-3661 | Outer Diameter 61 mm | In distribution |
| 1503-3168 | Lumen/Inner Diameter 28 mm | In distribution |
| 1503-3647 | Outer Diameter 47 mm | In distribution |
| 1503-3646 | Lumen/Inner Diameter 36 mm | In distribution |
| 1503-3662 | Lumen/Inner Diameter 36 mm | In distribution |
| 1503-3054 | Lumen/Inner Diameter 26 mm | In distribution |
| 1503-3169 | Outer Diameter 69 mm | In distribution |
| 1503-3253 | Outer Diameter 53 mm | In distribution |
| 1503-3073 | Outer Diameter 73 mm | In distribution |
| 1503-3156 | Lumen/Inner Diameter 28 mm | In distribution |
| 1503-3043 | Outer Diameter 43 mm | In distribution |
| 1503-3249 | Outer Diameter 49 mm | In distribution |
| 1503-3263 | Outer Diameter 63 mm | In distribution |
| 1503-3047 | Outer Diameter 47 mm | In distribution |
| 1503-3055 | Outer Diameter 55 mm | In distribution |
| 1503-3655 | Outer Diameter 55 mm | In distribution |
| 1503-3057 | Outer Diameter 57 mm | In distribution |
| 1503-3147 | Outer Diameter 47 mm | In distribution |
| 1503-3273 | Outer Diameter 73 mm | In distribution |
| 1503-3272 | Lumen/Inner Diameter 32 mm | In distribution |
| 1503-3056 | Lumen/Inner Diameter 26 mm | In distribution |
| 1503-3656 | Lumen/Inner Diameter 36 mm | In distribution |
| 1503-3051 | Outer Diameter 51 mm | In distribution |
| 1503-3063 | Outer Diameter 63 mm | In distribution |
| 1503-3069 | Outer Diameter 69 mm | In distribution |
| 1503-3162 | Lumen/Inner Diameter 28 mm | In distribution |
| 1503-3067 | Outer Diameter 67 mm | In distribution |
| 1503-3064 | Lumen/Inner Diameter 26 mm | In distribution |
| 1503-3663 | Outer Diameter 63 mm | In distribution |
| 1503-3146 | Lumen/Inner Diameter 28 mm | In distribution |
| 1503-3157 | Outer Diameter 57 mm | In distribution |
| 1503-3271 | Outer Diameter 71 mm | In distribution |
| 1503-3072 | Lumen/Inner Diameter 26 mm | In distribution |
| 1503-3060 | Lumen/Inner Diameter 26 mm | In distribution |
| 1503-3266 | Lumen/Inner Diameter 32 mm | In distribution |
| 1503-3245 | Outer Diameter 45 mm | In distribution |
| 1503-3260 | Lumen/Inner Diameter 32 mm | In distribution |
| 1503-3143 | Outer Diameter 43 mm | In distribution |
| 1503-3153 | Outer Diameter 53 mm | In distribution |
| 1503-3257 | Outer Diameter 57 mm | In distribution |
| 1503-3649 | Outer Diameter 49 mm | In distribution |
| 1503-3270 | Lumen/Inner Diameter 32 mm | In distribution |
| 1503-3251 | Outer Diameter 51 mm | In distribution |
| 1503-3259 | Outer Diameter 59 mm | In distribution |
| 1503-3152 | Lumen/Inner Diameter 28 mm | In distribution |
| 1503-3258 | Lumen/Inner Diameter 32 mm | In distribution |
| 1503-3059 | Outer Diameter 59 mm | In distribution |
| 1503-3160 | Lumen/Inner Diameter 28 mm | In distribution |
| 1503-3171 | Outer Diameter 71 mm | In distribution |
| 1503-3246 | Lumen/Inner Diameter 32 mm | In distribution |
| 1503-3653 | Outer Diameter 53 mm | In distribution |
| 1503-3150 | Lumen/Inner Diameter 28 mm | In distribution |
| 1503-3142 | Lumen/Inner Diameter 28 mm | In distribution |
| 1503-3666 | Lumen/Inner Diameter 36 mm | In distribution |
| 1503-3170 | Lumen/Inner Diameter 28 mm | In distribution |
| 1503-3650 | Lumen/Inner Diameter 36 mm | In distribution |
| 1503-3670 | Lumen/Inner Diameter 36 mm | In distribution |
| 1503-3648 | Lumen/Inner Diameter 36 mm | In distribution |
| 1503-3053 | Outer Diameter 53 mm | In distribution |
| 1503-3247 | Outer Diameter 47 mm | In distribution |
| 1503-3659 | Outer Diameter 59 mm | In distribution |
| 1503-3658 | Lumen/Inner Diameter 36 mm | In distribution |
| 1503-3172 | Lumen/Inner Diameter 28 mm | In distribution |
| 1503-3664 | Lumen/Inner Diameter 36 mm | In distribution |
| 1503-3066 | Lumen/Inner Diameter 26 mm | In distribution |
| 1503-3265 | Outer Diameter 65 mm | In distribution |
| 1503-3244 | Lumen/Inner Diameter 32 mm | In distribution |
| 1503-3049 | Outer Diameter 49 mm | In distribution |
| 1503-3673 | Outer Diameter 73 mm | In distribution |
| 1503-3269 | Outer Diameter 69 mm | In distribution |
| 1503-3155 | Outer Diameter 55 mm | In distribution |
| 1503-3173 | Outer Diameter 73 mm | In distribution |
| 1503-3261 | Outer Diameter 61 mm | In distribution |
| 1503-3256 | Lumen/Inner Diameter 32 mm | In distribution |
| 1503-3061 | Outer Diameter 61 mm | In distribution |
| 1503-3672 | Lumen/Inner Diameter 36 mm | In distribution |
| 1503-3667 | Outer Diameter 67 mm | In distribution |
| 1503-3159 | Outer Diameter 59 mm | In distribution |
| 1503-3262 | Lumen/Inner Diameter 32 mm | In distribution |
| 1503-3267 | Outer Diameter 67 mm | In distribution |
| 1503-3154 | Lumen/Inner Diameter 28 mm | In distribution |
| 1503-3052 | Lumen/Inner Diameter 26 mm | In distribution |
| 1503-3668 | Lumen/Inner Diameter 36 mm | In distribution |
| 1503-3252 | Lumen/Inner Diameter 32 mm | In distribution |
| 1503-3144 | Lumen/Inner Diameter 28 mm | In distribution |
| 1503-3044 | Lumen/Inner Diameter 26 mm | In distribution |
| 1503-3654 | Lumen/Inner Diameter 36 mm | In distribution |
| 1503-3248 | Lumen/Inner Diameter 32 mm | In distribution |
| 1503-3071 | Outer Diameter 71 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Resolve Modular Revision Hip Stem | United Orthopedic Corp. | 196 |
| Corin Bipolar Prosthesis | Corin Limited | 182 |
| Consensus® Hip System | Consensus Orthopedics, Inc. | 177 |
| Consensus Hip System | Shalby Advanced Technologies, Inc. | 177 |
| Instrument | Howmedica Osteonics Corp | 130 |
| Bencox Hip System | Corentec Co., Ltd. | 126 |
| MultiPolar® | Zimmer, Inc. | 100 |
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | Zimmer, Inc. | 96 |
| Fitmore® Hip Stem | Zimmer, Inc. | 75 |
| Arcos® Modular Revision System | Biomet Orthopedics | 67 |
| Acumatch L-Series | Exactech, Inc. | 67 |
| Corin BiPolar-i | Corin Limited | 54 |
Showing 12 of 352. All products under Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K152439 | 2016-04-07 |
| K101670 | 2010-10-08 |
| K050269 | 2005-08-29 |
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 |
|---|---|---|---|---|---|---|---|
| Orthopedic Alliance, LLC | 510(k) number | 2013-02-20 | Class II | Labeling design | The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and surgical techniques were not being provided to every physician and for every surgery. | 37 units | 2014-03-26 |
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.