Pivot Bipolar
28x59mm Bipolar
14manufacturers in China registered for this device type
38catalogue numbers in this listing
5510(k) clearances naming this product code
3recalls on this 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 | Ortho Development Corp., United States |
|---|---|
| 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 | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K050966 |
| Record published | 2015-08-31 |
| Record revised | 2020-09-09 (version 4) |
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 22 to 28 mm; outer diameter 38 to 60 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 133-2859 | Lumen/Inner Diameter 28 mm | In distribution |
| 133-2255 | Lumen/Inner Diameter 22 mm | In distribution |
| 133-2856 | Lumen/Inner Diameter 28 mm | In distribution |
| 133-2246 | Outer Diameter 46 mm | In distribution |
| 133-2256 | Outer Diameter 56 mm | In distribution |
| 133-2240 | Outer Diameter 40 mm | In distribution |
| 133-2238 | Outer Diameter 38 mm | In distribution |
| 133-2855 | Outer Diameter 55 mm | In distribution |
| 133-2851 | Lumen/Inner Diameter 28 mm | In distribution |
| 133-2850 | Outer Diameter 50 mm | In distribution |
| 133-2243 | Lumen/Inner Diameter 22 mm | In distribution |
| 133-2242 | Outer Diameter 42 mm | In distribution |
| 133-2259 | Outer Diameter 59 mm | In distribution |
| 133-2253 | Outer Diameter 53 mm | In distribution |
| 133-2239 | Lumen/Inner Diameter 22 mm | In distribution |
| 133-2257 | Outer Diameter 57 mm | In distribution |
| 133-2853 | Outer Diameter 53 mm | In distribution |
| 133-2260 | Lumen/Inner Diameter 22 mm | In distribution |
| 133-2254 | Outer Diameter 54 mm | In distribution |
| 133-2849 | Lumen/Inner Diameter 28 mm | In distribution |
| 133-2241 | Lumen/Inner Diameter 22 mm | In distribution |
| 133-2258 | Lumen/Inner Diameter 22 mm | In distribution |
| 133-2248 | Outer Diameter 48 mm | In distribution |
| 133-2245 | Lumen/Inner Diameter 22 mm | In distribution |
| 133-2250 | Lumen/Inner Diameter 22 mm | In distribution |
| 133-2249 | Lumen/Inner Diameter 22 mm | In distribution |
| 133-2848 | Lumen/Inner Diameter 28 mm | In distribution |
| 133-2252 | Outer Diameter 52 mm | In distribution |
| 133-2857 | Lumen/Inner Diameter 28 mm | In distribution |
| 133-2251 | Outer Diameter 51 mm | In distribution |
| 133-2846 | Outer Diameter 46 mm | In distribution |
| 133-2858 | Outer Diameter 58 mm | In distribution |
| 133-2860 | Lumen/Inner Diameter 28 mm | In distribution |
| 133-2247 | Outer Diameter 47 mm | In distribution |
| 133-2244 | Outer Diameter 44 mm | In distribution |
| 133-2854 | Outer Diameter 54 mm | In distribution |
| 133-2852 | Outer Diameter 52 mm | In distribution |
| 133-2847 | Outer Diameter 47 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 |
|---|---|
| K050966 | 2005-07-07 |
| K982389 | 1998-10-07 |
| K962448 | 1996-09-19 |
| K961793 | 1996-07-26 |
| K953977 | 1996-01-26 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Ortho Development Corp. | 510(k) number | 2014-07-11 | Class II | Packaging process control | Ortho Development is recalling various Pivot Bipolar Cup, Patella, PS Tibial Insert, UC Tibila Insert, and CK Tibil Insert because the foil pouches did not properly seal, allowing air to seep back into the pouch after sealing which increase | 188 | 2014-10-06 |
| Ortho Development Corp. | 510(k) number | 2009-04-29 | Not classified | Device Design | A Pivot BiPolar Head, the femoral head in a hip prosthesis, might not move freely after assembly due a stacking up of manufacturing tolerances. | 23 | 2010-05-25 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2010-07-28 | Not classified | Nonconforming Material/Component | The hip stem did not fit the distal centralizer because the hole was not drilled with the appropriate taper. | 39 units | 2010-11-04 |
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.