B-P Total HIP System
B-P HIP Acetabular Fixation CUP W/Biocoat & W/Ultracoat - 52 MM 0 Hole
13manufacturers in China registered for this device type
151catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (6), 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 |
| 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 |
| 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 |
| b-ONE Medical (Beijing) Co., Ltd. | Beijing | Beijing | 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 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
Showing 12 of 13. All 13 manufacturers in China registered for Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Record
| Listed by | Endotec, Inc., United States |
|---|---|
| FDA product code | JDI |
| Device type | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3350 |
| 510(k) | K963101 |
| Record published | 2015-09-17 |
| Record revised | 2024-04-18 (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 | Width 9 to 50 mm; length 25 to 200 mm; outer diameter 46 to 70 mm; lumen/inner diameter 28 to 52.5 mm |
| Distribution end date | 2024-03-04 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 01-02-3250 | Outer Diameter 50 mm | In distribution |
| 01-16-0420 | Length 100 mm | In distribution |
| 01-16-0814 | Length 200 mm | In distribution |
| 01-16-0314 | Length 75 mm | In distribution |
| 01-16-0818 | Length 200 mm | In distribution |
| 01-16-0520 | Length 125 mm | In distribution |
| 01-02-3848 | Outer Diameter 48 mm | In distribution |
| 01-16-0519 | Length 125 mm | In distribution |
| 01-01-0052 | 0 HOLE | In distribution |
| 01-16-0710 | Length 175 mm | In distribution |
| 01-01-0066 | 0 HOLE | In distribution |
| 01-16-0316 | Length 75 mm | In distribution |
| 01-16-0809 | Length 200 mm | In distribution |
| 01-02-5266 | Outer Diameter 70 mm | In distribution |
| 01-01-0058 | 0 HOLE | In distribution |
| 01-16-0310 | Length 75 mm | In distribution |
| 01-16-0414 | Length 100 mm | In distribution |
| 01-16-0219 | Length 50 mm | In distribution |
| 01-16-0810 | Length 200 mm | In distribution |
| 01-16-0617 | Length 150 mm | In distribution |
| 01-16-0509 | Length 125 mm | In distribution |
| 01-01-0050 | 0 HOLE | In distribution |
| 01-02-3264 | Outer Diameter 64 mm | In distribution |
| 01-01-0068 | 0 HOLE | In distribution |
| 01-02-2852 | Outer Diameter 52 mm | In distribution |
| 01-16-0612 | Length 150 mm | In distribution |
| 01-16-0510 | Length 125 mm | In distribution |
| 01-16-0217 | Length 50 mm | In distribution |
| 01-16-0619 | Length 150 mm | In distribution |
| 01-16-0715 | Length 175 mm | In distribution |
| 01-16-0515 | Length 125 mm | In distribution |
| 01-16-0213 | Length 50 mm | In distribution |
| 01-01-0054 | 0 HOLE | In distribution |
| 01-16-0100 | NULL SIZE | In distribution |
| 01-01-0060 | 0 HOLE | In distribution |
| 01-02-3252 | Outer Diameter 52 mm | In distribution |
| 01-16-0817 | Length 200 mm | In distribution |
| 01-16-0309 | Length 75 mm | In distribution |
| 01-16-0513 | Length 125 mm | In distribution |
| 01-16-0317 | Length 75 mm | In distribution |
| 01-16-0718 | Length 175 mm | In distribution |
| 01-02-2860 | Outer Diameter 60 mm | In distribution |
| 01-01-0064 | 0 HOLE | In distribution |
| 01-16-0610 | Length 150 mm | In distribution |
| 01-16-0312 | Length 75 mm | In distribution |
| 01-16-0711 | Length 175 mm | In distribution |
| 01-02-3262 | Outer Diameter 62 mm | In distribution |
| 01-01-0056 | 0 HOLE | In distribution |
| 01-16-0410 | Length 100 mm | In distribution |
| 01-16-0811 | Length 200 mm | In distribution |
| 01-16-0315 | Length 75 mm | In distribution |
| 01-02-2856 | Outer Diameter 56 mm | In distribution |
| 01-16-0318 | Length 75 mm | In distribution |
| 01-16-0511 | Length 125 mm | In distribution |
| 01-16-0417 | Length 100 mm | In distribution |
| 01-16-0816 | Length 200 mm | In distribution |
| 01-16-0313 | Length 75 mm | In distribution |
| 01-16-0613 | Length 150 mm | In distribution |
| 01-16-0717 | Length 175 mm | In distribution |
| 01-16-0416 | Length 100 mm | In distribution |
| 01-16-0114 | Length 25 mm | Withdrawn |
| 01-16-0319 | Length 75 mm | Withdrawn |
| 01-02-3254 | Outer Diameter 54 mm | Withdrawn |
| 01-16-0210 | Length 50 mm | Withdrawn |
| 01-16-0518 | Length 125 mm | Withdrawn |
| 01-16-0209 | Width 50 mm | Withdrawn |
| 01-16-0409 | Length 100 mm | Withdrawn |
| 01-01-0560 | 5 HOLE | Withdrawn |
| 01-16-0611 | Length 150 mm | Withdrawn |
| 01-16-0813 | Length 200 mm | Withdrawn |
| 01-16-0517 | Length 125 mm | Withdrawn |
| 01-02-3646 | Outer Diameter 46 mm | Withdrawn |
| 01-16-0115 | Length 25 mm | Withdrawn |
| 01-16-0116 | Length 25 mm | Withdrawn |
| 01-16-0714 | Length 175 mm | Withdrawn |
| 01-16-0109 | Length 25 mm | Withdrawn |
| 01-16-0215 | Length 50 mm | Withdrawn |
| 01-02-2850 | Outer Diameter 50 mm | Withdrawn |
| 01-01-0556 | 5 HOLE | Withdrawn |
| 01-02-3258 | Outer Diameter 58 mm | Withdrawn |
| 01-01-0564 | 5 HOLE | Withdrawn |
| 01-16-0214 | Length 50 mm | Withdrawn |
| 01-16-0118 | Length 25 mm | Withdrawn |
| 01-02-4760 | Outer Diameter 60 mm | Withdrawn |
| 01-16-0113 | Length 25 mm | Withdrawn |
| 01-16-0713 | Length 175 mm | Withdrawn |
| 01-16-0709 | Length 175 mm | Withdrawn |
| 01-16-0413 | Length 100 mm | Withdrawn |
| 01-16-0712 | Length 175 mm | Withdrawn |
| 01-16-0218 | Length 50 mm | Withdrawn |
| 01-16-0512 | Length 125 mm | Withdrawn |
| 01-02-3256 | Outer Diameter 56 mm | Withdrawn |
| 01-01-0562 | 5 HOLE | Withdrawn |
| 01-16-0111 | Length 25 mm | Withdrawn |
| 01-16-0211 | Length 50 mm | Withdrawn |
| 01-16-0514 | Length 125 mm | Withdrawn |
| 01-16-0609 | Length 150 mm | Withdrawn |
| 01-01-0554 | 5 HOLE | Withdrawn |
| 01-01-0548 | 5 HOLE | Withdrawn |
| 01-16-0119 | Length 25 mm | Withdrawn |
| 01-16-0815 | Length 200 mm | Withdrawn |
| 01-16-0411 | Length 100 mm | Withdrawn |
| 01-16-0418 | Length 100 mm | Withdrawn |
| 01-01-0566 | 5 HOLE | Withdrawn |
| 01-16-0516 | Length 125 mm | Withdrawn |
| 01-16-0812 | Length 200 mm | Withdrawn |
| 01-16-0620 | Length 150 mm | Withdrawn |
| 01-16-0716 | Length 175 mm | Withdrawn |
| 01-01-0570 | 5 HOLE | Withdrawn |
| 01-16-0616 | Length 150 mm | Withdrawn |
| 01-16-0819 | Length 200 mm | Withdrawn |
| 01-02-2854 | Outer Diameter 54 mm | Withdrawn |
| 01-16-0412 | Length 100 mm | Withdrawn |
| 01-02-3260 | Outer Diameter 60 mm | Withdrawn |
| 01-02-4254 | Outer Diameter 54 mm | Withdrawn |
| 01-16-0618 | Length 150 mm | Withdrawn |
| 01-01-0048 | 0 HOLE | Withdrawn |
| 01-16-0212 | Length 50 mm | Withdrawn |
| 01-16-0220 | Length 50 mm | Withdrawn |
| 01-01-0046 | 0 HOLE | Withdrawn |
| 01-16-0614 | Length 150 mm | Withdrawn |
| 01-01-0558 | 5 HOLE | Withdrawn |
| 01-01-0552 | 5 HOLE | Withdrawn |
| 01-02-5164 | Outer Diameter 64 mm | Withdrawn |
| 01-02-4456 | Outer Diameter 56 mm | Withdrawn |
| 01-16-0720 | Length 175 mm | Withdrawn |
| 01-02-2848 | Outer Diameter 48 mm | Withdrawn |
| 01-02-4962 | Outer Diameter 62 mm | Withdrawn |
| 01-16-0112 | Length 25 mm | Withdrawn |
| 01-16-0615 | Length 150 mm | Withdrawn |
| 01-16-0117 | Length 25 mm | Withdrawn |
| 01-01-0070 | 0 HOLE | Withdrawn |
| 01-16-0120 | Length 25 mm | Withdrawn |
| 01-01-0550 | 5 HOLE | Withdrawn |
| 01-02-2858 | Outer Diameter 58 mm | Withdrawn |
| 01-02-4152 | Outer Diameter 52 mm | Withdrawn |
| 01-16-0415 | Length 100 mm | Withdrawn |
| 01-16-0719 | Length 175 mm | Withdrawn |
| 01-01-0568 | 5 HOLE | Withdrawn |
| 01-16-0820 | Length 200 mm | Withdrawn |
| 01-16-0110 | Length 25 mm | Withdrawn |
| 01-02-3950 | Outer Diameter 50 mm | Withdrawn |
| 01-01-0062 | 0 HOLE | Withdrawn |
| 01-16-0419 | Length 100 mm | Withdrawn |
| 01-16-0320 | Length 75 mm | Withdrawn |
| 01-02-4558 | Outer Diameter 58 mm | Withdrawn |
| 01-02-3266 | Outer Diameter 66 mm | Withdrawn |
| 01-01-0546 | 5 HOLE | Withdrawn |
| 01-16-0216 | Length 50 mm | Withdrawn |
| 01-02-2846 | Outer Diameter 46 mm | Withdrawn |
| 01-16-0311 | Length 75 mm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | Zimmer, Inc. | 836 |
| R3 | Smith & Nephew, Inc. | 497 |
| UniSyn Hip System | Shalby Advanced Technologies, Inc. | 247 |
| UniSyn® Hip System | Consensus Orthopedics, Inc. | 247 |
| Reflection | Smith & Nephew, Inc. | 170 |
| Instrument | Howmedica Osteonics Corp | 167 |
| Echelon | Smith & Nephew, Inc. | 159 |
| ZCA® | Zimmer, Inc. | 149 |
| Omnifit | Howmedica Osteonics Corp | 149 |
| Ringloc HIP System | Biomet Orthopedics | 139 |
| Profemur | Microport Orthopedics Inc. | 113 |
| OSS™ Orthopedic Salvage System | Biomet Orthopedics | 98 |
Showing 12 of 444. All products under Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K960425 | 1996-10-03 |
| K905262 | 1993-05-19 |
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.