B-P Total HIP System
B-P HIP Self-Aligning Acetabular CUP & Bearing - 28 MM I.D. X 41 MM O.D.
10manufacturers in China registered for this device type
66catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (4), Shanghai (3), Zhejiang (2). 6 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 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Xian Airfoil Technology Co., Ltd. | Xian | Shaanxi | Contract manufacturer | 8 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
Record
| Listed by | Endotec, Inc., United States |
|---|---|
| FDA product code | KWL |
| Device type | Prosthesis, Hip, Hemi-, Femoral, Metal |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3360 |
| 510(k) | K884789 |
| Record published | 2015-09-17 |
| Record revised | 2024-04-10 (version 7) |
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 |
| Storage | Storage environment temperature 5 to 40 °C; Handling environment temperature 5 to 40 °C |
| Sizes | Outer diameter 39 to 58 mm; lumen/inner diameter 28 to 32 mm; width 8 to 16 mm |
| Distribution end date | 2024-03-04 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 01-17-2851 | Outer Diameter 51 mm | In distribution |
| 01-04-0412 | Width 12 mm | In distribution |
| 01-04-0411 | Width 11 mm | In distribution |
| 01-04-0113 | Width 13 mm | In distribution |
| 01-17-2840 | Outer Diameter 40 mm | In distribution |
| 01-17-2853 | Outer Diameter 53 mm | In distribution |
| 01-17-2846 | Outer Diameter 46 mm | In distribution |
| 01-17-2843 | Outer Diameter 43 mm | In distribution |
| 01-17-2845 | Outer Diameter 45 mm | In distribution |
| 01-04-0415 | Width 15 mm | In distribution |
| 01-21-0112 | Width 12 mm | In distribution |
| 01-04-0108 | Width 8 mm | In distribution |
| 01-17-2847 | Outer Diameter 47 mm | In distribution |
| 01-04-0110 | Width 10 mm | In distribution |
| 01-17-2850 | Outer Diameter 50 mm | In distribution |
| 01-04-0114 | Width 14 mm | In distribution |
| 01-17-2849 | Outer Diameter 49 mm | In distribution |
| 01-21-0111 | Width 11 mm | In distribution |
| 01-17-2855 | Outer Diameter 55 mm | In distribution |
| 01-04-0109 | Width 9 mm | In distribution |
| 01-17-2844 | Outer Diameter 44 mm | In distribution |
| 01-21-0116 | Width 16 mm | In distribution |
| 01-17-2842 | Outer Diameter 42 mm | In distribution |
| 01-04-0111 | Width 11 mm | In distribution |
| 01-04-0409 | Width 9 mm | Withdrawn |
| 01-17-2841 | Outer Diameter 41 mm | Withdrawn |
| 01-17-2852 | Outer Diameter 52 mm | Withdrawn |
| 01-17-2858 | Outer Diameter 58 mm | Withdrawn |
| 01-17-3250 | Outer Diameter 50 mm | Withdrawn |
| 01-17-2856 | Outer Diameter 56 mm | Withdrawn |
| 01-17-3247 | Outer Diameter 47 mm | Withdrawn |
| 01-04-0115 | Width 15 mm | Withdrawn |
| 01-17-3244 | Outer Diameter 44 mm | Withdrawn |
| 01-21-0114 | Width 14 mm | Withdrawn |
| 01-17-2854 | Outer Diameter 54 mm | Withdrawn |
| 01-17-3252 | Outer Diameter 52 mm | Withdrawn |
| 01-17-3249 | Outer Diameter 49 mm | Withdrawn |
| 01-17-3254 | Outer Diameter 54 mm | Withdrawn |
| 01-17-3239 | Outer Diameter 39 mm | Withdrawn |
| 01-17-3245 | Outer Diameter 45 mm | Withdrawn |
| 01-17-3243 | Outer Diameter 43 mm | Withdrawn |
| 01-04-0112 | Width 12 mm | Withdrawn |
| 01-17-3257 | Outer Diameter 57 mm | Withdrawn |
| 01-17-3242 | Outer Diameter 42 mm | Withdrawn |
| 01-04-0410 | Width 10 mm | Withdrawn |
| 01-04-0408 | Width 8 mm | Withdrawn |
| 01-17-3246 | Outer Diameter 46 mm | Withdrawn |
| 01-21-0113 | Width 13 mm | Withdrawn |
| 01-17-3251 | Outer Diameter 51 mm | Withdrawn |
| 01-17-3255 | Outer Diameter 55 mm | Withdrawn |
| 01-04-0416 | Width 16 mm | Withdrawn |
| 01-04-0413 | Width 13 mm | Withdrawn |
| 01-04-0414 | Width 14 mm | Withdrawn |
| 01-17-3256 | Outer Diameter 56 mm | Withdrawn |
| 01-17-2857 | Outer Diameter 57 mm | Withdrawn |
| 01-17-3241 | Outer Diameter 41 mm | Withdrawn |
| 01-21-0115 | Width 15 mm | Withdrawn |
| 01-17-3240 | Outer Diameter 40 mm | Withdrawn |
| 01-17-2848 | Outer Diameter 48 mm | Withdrawn |
| 01-17-3248 | Outer Diameter 48 mm | Withdrawn |
| 01-04-0116 | Width 16 mm | Withdrawn |
| 01-21-0110 | Width 10 mm | Withdrawn |
| 01-21-0109 | Width 9 mm | Withdrawn |
| 01-17-3258 | Outer Diameter 58 mm | Withdrawn |
| 01-17-2839 | Outer Diameter 39 mm | Withdrawn |
| 01-17-3253 | Outer Diameter 53 mm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ustar II Knee System | United Orthopedic Corp. | 115 |
| Consensus Hip System | Shalby Advanced Technologies, Inc. | 95 |
| Consensus® Hip System | Consensus Orthopedics, Inc. | 95 |
| Instrument | Howmedica Osteonics Corp | 94 |
| UHR | Howmedica Osteonics Corp | 75 |
| Austin Moore | Howmedica Osteonics Corp | 67 |
| CS2 Acetabular Cup System | Consensus Orthopedics, Inc. | 64 |
| DJO Surgical | Encore Medical, L.P. | 62 |
| Restoration | Howmedica Osteonics Corp | 56 |
| Optimom Modular Heads | Corin Limited | 49 |
| Corin Unipolar Modular Head | Corin Limited | 36 |
| Perfecta | Microport Orthopedics Inc. | 35 |
Showing 12 of 167. All products under Prosthesis, Hip, Hemi-, Femoral, Metal
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.