U2 Bipolar Implant
U2 Bipolar Implant is a hip replacement component assembled during surgery with a compatible UNITED femoral stem and head. It combines a cobalt-chromium-molybdenum outer shell with a…
U2 Bipolar Implant is a hip replacement component assembled during surgery with a compatible UNITED femoral stem and head. It combines a cobalt-chromium-molybdenum outer shell with a permanently assembled polyethylene bearing insert. Movement occurs both between the femoral head and inner bearing and between the outer shell and the acetabulum.
The range has outer diameters from 38 to 56 mm and inner diameters of 22, 26 or 28 mm. The shell locks the polyethylene liner in place, while its polished outer surface articulates with the patient’s acetabulum. The polyethylene is at least 5 mm thick at the load-bearing area.
Listed Item
U2 Bipolar Implant, 22mm I.D., 38mm O.D.
Replacement Indications
Used with the UNITED Femoral System, the implant supports cemented or cementless hip replacement for inflammatory or noninflammatory degenerative joint disease, functional deformity correction and revision after failed treatment. It is also indicated for specified proximal femoral fractures with head involvement when other techniques cannot manage them.
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) | K152439 |
| Record published | 2016-06-06 |
| Record revised | 2022-09-16 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Sizes | Outer diameter 38 to 42 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1503-3338 | Outer Diameter 38 mm | In distribution |
| 1503-4144-RD | In distribution | |
| 1503-4151-RD | In distribution | |
| 9204-8041-RT | In distribution | |
| 1503-4249 | In distribution | |
| 1503-4338-RD | In distribution | |
| 1503-3342 | Outer Diameter 42 mm | In distribution |
| 1503-4042-RD | In distribution | |
| 1503-4149-RD | In distribution | |
| 1503-4341-RD | In distribution | |
| 1503-4340-RB | ID22mm, OD40mm | In distribution |
| 1503-4255 | In distribution | |
| 1503-4041-RD | In distribution | |
| 1503-4150-RD | In distribution | |
| 1503-4148-RD | In distribution | |
| 1503-4253 | In distribution | |
| 1503-4147-RD | In distribution | |
| 1503-4154-RD | In distribution | |
| 1503-4252 | In distribution | |
| 1503-4146-RD | In distribution | |
| 1503-3341 | Outer Diameter 41 mm | In distribution |
| 1503-4248 | In distribution | |
| 1503-4342-RD | In distribution | |
| 9204-8040 | In distribution | |
| 1503-4256 | In distribution | |
| 1503-4251 | In distribution | |
| 1503-4152-RD | In distribution | |
| 1503-4338-RB | ID22mm, OD38mm | In distribution |
| 1503-4156-RD | In distribution | |
| 1503-4339-RD | In distribution | |
| 1503-4250 | In distribution | |
| 1503-4339-RB | ID22mm, OD39mm | In distribution |
| 1503-4340-RD | In distribution | |
| 1503-4254 | In distribution | |
| 1503-4158 | In distribution | |
| 1503-4341-RB | ID22mm, OD41mm | In distribution |
| 1503-4160 | In distribution | |
| 1503-4342-RB | ID22mm, OD42mm | In distribution |
| 9204-8041-RB | In distribution | |
| 1503-4145-RD | In distribution | |
| 1503-3340 | Outer Diameter 40 mm | In distribution |
| 1503-4155-RD | In distribution | |
| 1503-4143-RD | In distribution | |
| 1503-4153-RD | In distribution | |
| 1503-4247 | In distribution | |
| 1503-3339 | Outer Diameter 39 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 |
| United Hip System, U2 Bipolar Implant | United Orthopedic Corp. | 123 |
| 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 |
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.