B-P Total Knee System
B-P Knee Thick Modular Tibial Platform W/Screw, W/Biocoat, W/Ultracoat, Type 3, Size 5
Who Else Makes It
Concentrated in Jiangsu (10), Shanghai (4), Beijing (3). 13 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 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| Guangzhou Aquila Precise Tools Limited | Guangzhou | Guangdong | Contract manufacturer | 28 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Stryker Orthmed (Changzhou) Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 10 |
| b-ONE Medical (Beijing) Co., Ltd. | Beijing | Beijing | Contract manufacturer | 7 |
| Changzhou Wastonortho Medical Appliance Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 5 |
Showing 12 of 21. All 21 manufacturers in China registered for Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Record
| Listed by | Endotec, Inc., United States |
|---|---|
| FDA product code | JWH |
| Device type | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3560 |
| 510(k) | K012702 |
| Record published | 2015-09-17 |
| Record revised | 2024-04-11 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| 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 0 to 10 mm |
| Distribution end date | 2024-03-04 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 04-32-0625 | SIZE 5.5 TYPE 3 | In distribution |
| 04-31-2206 | SIZE 6, LEFT | In distribution |
| 04-32-0406 | SIZE 6, TYPE 1 | In distribution |
| 04-32-0062 | SIZE 2, TYPE 0 | In distribution |
| 04-32-0663 | SIZE 3.5, TYPE 0 | In distribution |
| 04-32-0104 | SIZE 4, TYPE 1 | In distribution |
| 04-31-2301 | SIZE 1, LEFT | In distribution |
| 04-32-0001 | SIZE 1, TYPE 1 | In distribution |
| 04-32-0126 | SIZE 6, TYPE 3 | In distribution |
| 04-32-0304 | SIZE 4, TYPE 1 | In distribution |
| 04-31-1006 | SIZE 6, RIGHT | In distribution |
| 04-33-0131 | Width 7.5 mm | In distribution |
| 04-32-0006 | TYPE 1, SIZE 6 | In distribution |
| 04-31-1205 | SIZE 5, RIGHT | In distribution |
| 04-32-0322 | SIZE 2, TYPE 3 | In distribution |
| 04-32-0862 | SIZE 2.5, TYPE 0 | In distribution |
| 04-33-0123 | Width 5 mm | In distribution |
| 04-32-0106 | SIZE 6, TYPE 1 | In distribution |
| 04-32-0004 | TYPE 1, SIZE 4 | In distribution |
| 04-34-0604 | SIZE 4 | In distribution |
| 04-33-0141 | Width 10 mm | In distribution |
| 04-32-0815 | SIZE 5.5, TYPE 2 | In distribution |
| 04-31-2103 | SIZE 3, LEFT | In distribution |
| 04-32-0111 | SIZE 1, TYPE 2 | In distribution |
| 04-32-0864 | SIZE 4.5, TYPE 0 | In distribution |
| 04-31-1202 | SIZE 2, RIGHT | In distribution |
| 04-31-1203 | SIZE 3, RIGHT | In distribution |
| 04-33-0115 | Width 2.5 mm | In distribution |
| 04-34-0602 | SIZE 2 | In distribution |
| 04-32-0002 | TYPE 1, SIZE 2 | In distribution |
| 03-12-0036 | SIZE 4-6 | In distribution |
| 04-32-0124 | SIZE 4, TYPE 3 | In distribution |
| 04-31-1305 | SIZE 5, RIGHT | In distribution |
| 04-31-2101 | SIZE 1, LEFT | In distribution |
| 04-32-0812 | SIZE 2.5, TYPE 2 | In distribution |
| 04-33-0146 | Width 10 mm | In distribution |
| 04-31-1301 | SIZE 1, RIGHT | In distribution |
| 04-31-1201 | SIZE 1, RIGHT | In distribution |
| 04-32-0824 | SIZE 4.5, TYPE 3 | In distribution |
| 04-32-0122 | SIZE 2, TYPE 3 | In distribution |
| 04-32-0116 | SIZE 6, TYPE 2 | In distribution |
| 04-32-0366 | SIZE 6, TYPE 0 | In distribution |
| 04-32-0801 | SIZE 1.5, TYPE 1 | In distribution |
| 04-32-0023 | SIZE 3, TYPE 3 | In distribution |
| 04-31-1101 | SIZE 1, RIGHT | In distribution |
| 04-31-1003 | SIZE 3, RIGHT | In distribution |
| 04-32-0811 | SIZE 1.5, TYPE 2 | In distribution |
| 04-32-0306 | SIZE 6, TYPE 1 | In distribution |
| 04-31-1005 | SIZE 5, RIGHT | In distribution |
| 04-31-1105 | SIZE 5, RIGHT | In distribution |
| 04-33-0121 | Width 5 mm | In distribution |
| 04-32-0803 | SIZE 3.5, TYPE 1 | In distribution |
| 04-31-1002 | SIZE 2, RIGHT | In distribution |
| 04-34-0603 | SIZE 3 | In distribution |
| 04-33-0105 | Width 0 mm | In distribution |
| 04-32-0305 | SIZE 5, TYPE 1 | In distribution |
| 04-32-0021 | SIZE 1, TYPE 3 | In distribution |
| 04-32-0611 | SIZE 1.5, TYPE 2 | In distribution |
| 04-32-0401 | SIZE 1, TYPE 1 | In distribution |
| 04-32-0314 | SIZE 4, TYPE 2 | In distribution |
| 04-33-0112 | Width 2.5 mm | In distribution |
| 04-31-2004 | SIZE 4, LEFT | In distribution |
| 04-32-0105 | SIZE 5, TYPE 1 | In distribution |
| 04-32-0865 | SIZE 5.5, TYPE 0 | In distribution |
| 04-32-0365 | SIZE 5, TYPE 0 | In distribution |
| 04-32-0814 | SIZE 4.5, TYPE 2 | In distribution |
| 04-31-1505 | SIZE 5, RIGHT | In distribution |
| 04-33-0126 | Width 5 mm | In distribution |
| 04-32-0605 | SIZE 5.5, TYPE 1 | In distribution |
| 04-32-0621 | SIZE 1.5, TYPE 3 | In distribution |
| 04-33-0122 | Width 5 mm | In distribution |
| 04-32-0861 | SIZE 1.5, TYPE 0 | In distribution |
| 04-32-0163 | SIZE 3, TYPE 0 | In distribution |
| 04-32-0103 | SIZE 3, TYPE 1 | In distribution |
| 04-32-0404 | SIZE 4, TYPE 1 | In distribution |
| 04-32-0613 | SIZE 3.5, TYPE 2 | In distribution |
| 04-33-0116 | Width 2.5 mm | In distribution |
| 04-32-0825 | SIZE 5.5, TYPE 3 | In distribution |
| 04-32-0026 | SIZE 6, TYPE 3 | In distribution |
| 04-34-0002 | SIZE 2 | In distribution |
| 04-32-0303 | SIZE 3, TYPE 1 | In distribution |
| 04-32-0123 | SIZE 3, TYPE 3 | In distribution |
| 04-32-0822 | SIZE 2.5, TYPE 3 | In distribution |
| 04-31-2504 | SIZE 4, LEFT | In distribution |
| 04-32-0114 | SIZE 4, TYPE 2 | In distribution |
| 04-33-0145 | Width 10 mm | In distribution |
| 04-32-0664 | SIZE 4.5, TYPE 0 | In distribution |
| 04-31-2204 | SIZE 4, LEFT | In distribution |
| 04-32-0162 | SIZE 2, TYPE 0 | In distribution |
| 04-32-0614 | SIZE 4.5, TYPE 2 | In distribution |
| 04-32-0166 | SIZE 6, TYPE 0 | In distribution |
| 04-33-0103 | Width 0 mm | In distribution |
| 04-32-0363 | SIZE 3, TYPE 0 | In distribution |
| 04-32-0402 | SIZE 2, TYPE 1 | In distribution |
| 04-32-0014 | SIZE 4, TYPE 2 | In distribution |
| 04-31-2005 | SIZE 5, LEFT | In distribution |
| 04-32-0102 | SIZE 2, TYPE 1 | In distribution |
| 04-34-0605 | SIZE 5 | In distribution |
| 04-32-0411 | SIZE 1, TYPE 2 | In distribution |
| 04-32-0115 | SIZE 5, TYPE 2 | In distribution |
| 04-31-2203 | SIZE 3, LEFT | In distribution |
| 04-32-0821 | SIZE 1.5, TYPE 3 | In distribution |
| 04-32-0121 | SIZE 1, TYPE 3 | In distribution |
| 04-32-0125 | SIZE 5, TYPE 3 | In distribution |
| 04-32-0405 | SIZE 5, TYPE 1 | In distribution |
| 04-31-1206 | SIZE 6, RIGHT | Withdrawn |
| 04-33-0124 | Width 5 mm | Withdrawn |
| 04-32-0325 | SIZE 5, TYPE 3 | Withdrawn |
| 04-32-0802 | SIZE 2.5, TYPE 1 | Withdrawn |
| 04-34-0205 | SIZE 5 | Withdrawn |
| 04-32-0413 | SIZE 3, TYPE 2 | Withdrawn |
| 04-32-0066 | SIZE 6, TYPE 0 | Withdrawn |
| 04-31-1302 | SIZE 2, RIGHT | Withdrawn |
| 04-33-0143 | Width 10 mm | Withdrawn |
| 04-32-0012 | SIZE 2, TYPE 2 | Withdrawn |
| 04-32-0165 | SIZE 5, TYPE 0 | Withdrawn |
| 04-33-0102 | Width 0 mm | Withdrawn |
| 04-34-0004 | SIZE 4 | Withdrawn |
| 04-32-0113 | SIZE 3, TYPE 2 | Withdrawn |
| 04-32-0603 | SIZE 3.5, TYPE 1 | Withdrawn |
| 04-31-2201 | SIZE 1, LEFT | Withdrawn |
| 04-31-1103 | SIZE 3, RIGHT | Withdrawn |
| 04-34-0206 | SIZE 6 | Withdrawn |
| 04-32-0412 | SIZE 2, TYPE 2 | Withdrawn |
| 04-31-2304 | SIZE 4, LEFT | Withdrawn |
| 04-34-0203 | SIZE 3 | Withdrawn |
| 04-32-0804 | SIZE 4.5, TYPE 1 | Withdrawn |
| 04-32-0414 | SIZE 4, TYPE 2 | Withdrawn |
| 04-31-2104 | SIZE 4, LEFT | Withdrawn |
| 04-31-2205 | SIZE 5, LEFT | Withdrawn |
| 04-31-2501 | SIZE 1, LEFT | Withdrawn |
| 04-34-0601 | SIZE 1 | Withdrawn |
| 04-31-2306 | SIZE 6, LEFT | Withdrawn |
| 04-32-0602 | SIZE 2.5, TYPE 1 | Withdrawn |
| 04-32-0361 | SIZE 1, TYPE 0 | Withdrawn |
| 04-33-0133 | Width 7.5 mm | Withdrawn |
| 04-32-0415 | SIZE 5, TYPE 2 | Withdrawn |
| 04-32-0101 | SIZE 1, TYPE 1 | Withdrawn |
| 04-33-0134 | Width 7.5 mm | Withdrawn |
| 04-32-0462 | SIZE 2, TYPE 0 | Withdrawn |
| 04-34-0003 | SIZE 3 | Withdrawn |
| 04-31-2202 | SIZE 2, LEFT | Withdrawn |
| 04-31-1504 | SIZE 4, RIGHT | Withdrawn |
| 04-31-2505 | SIZE 5, LEFT | Withdrawn |
| 04-31-1004 | SIZE 4, RIGHT | Withdrawn |
| 04-33-0142 | Width 10 mm | Withdrawn |
| 04-32-0065 | SIZE 5, TYPE 0 | Withdrawn |
| 04-33-0132 | Width 7.5 mm | Withdrawn |
| 04-33-0144 | Width 10 mm | Withdrawn |
| 04-32-0013 | SIZE 3, TYPE 2 | Withdrawn |
| 04-32-0064 | SIZE 4, TYPE 0 | Withdrawn |
| 04-31-2102 | SIZE 2, LEFT | Withdrawn |
| 04-32-0015 | SIZE 5, TYPE 2 | Withdrawn |
| 04-32-0423 | SIZE 3, TYPE 3 | Withdrawn |
| 04-32-0312 | SIZE 2, TYPE 2 | Withdrawn |
| 04-32-0662 | SIZE 2.5, TYPE 0 | Withdrawn |
| 04-32-0025 | SIZE 5, TYPE 3 | Withdrawn |
| 04-32-0604 | SIZE 4.5, TYPE 1 | Withdrawn |
| 04-31-1303 | SIZE 3, RIGHT | Withdrawn |
| 04-32-0823 | SIZE 3.5, TYPE 3 | Withdrawn |
| 04-32-0624 | SIZE 4.5, TYPE 3 | Withdrawn |
| 04-32-0622 | SIZE 2.5, TYPE 3 | Withdrawn |
| 04-32-0362 | SIZE 2, TYPE 0 | Withdrawn |
| 04-31-1503 | SIZE 3, RIGHT | Withdrawn |
| 04-32-0323 | SIZE 3, TYPE 3 | Withdrawn |
| 04-31-1104 | SIZE 4, RIGHT | Withdrawn |
| 04-32-0003 | TYPE 1, SIZE 3 | Withdrawn |
| 04-33-0104 | Width 0 mm | Withdrawn |
| 04-31-1502 | SIZE 2, RIGHT | Withdrawn |
| 03-12-0012 | SIZE 1-3 | Withdrawn |
| 04-32-0465 | SIZE 5, TYPE 0 | Withdrawn |
| 04-32-0426 | SIZE 6, TYPE 3 | Withdrawn |
| 04-31-1204 | SIZE 4, RIGHT | Withdrawn |
| 04-31-2002 | SIZE 2, LEFT | Withdrawn |
| 04-32-0461 | SIZE 1, TYPE 0 | Withdrawn |
| 04-32-0161 | SIZE 1, TYPE 0 | Withdrawn |
| 04-32-0364 | SIZE 4, TYPE 0 | Withdrawn |
| 04-31-2303 | SIZE 3, LEFT | Withdrawn |
| 04-32-0661 | SIZE 1.5, TYPE 0 | Withdrawn |
| 04-31-1306 | SIZE 6, RIGHT | Withdrawn |
| 04-34-0606 | SIZE 6 | Withdrawn |
| 04-32-0813 | SIZE 3.5, TYPE 2 | Withdrawn |
| 04-31-2106 | SIZE 6, LEFT | Withdrawn |
| 04-32-0422 | SIZE 2, TYPE 3 | Withdrawn |
| 04-31-2006 | SIZE 6, LEFT | Withdrawn |
| 04-31-2502 | SIZE 2, LEFT | Withdrawn |
| 04-33-0135 | Width 7.5 mm | Withdrawn |
| 04-31-2105 | SIZE 5, LEFT | Withdrawn |
| 04-33-0114 | Width 2.5 mm | Withdrawn |
| 04-33-0101 | Width 0 mm | Withdrawn |
| 04-32-0311 | SIZE 1, TYPE 2 | Withdrawn |
| 04-32-0324 | SIZE 4, TYPE 3 | Withdrawn |
| 04-31-1501 | SIZE 1, RIGHT | Withdrawn |
| 04-32-0301 | SIZE 1, TYPE 1 | Withdrawn |
| 04-34-0006 | SIZE 6 | Withdrawn |
| 04-32-0315 | SIZE 5, TYPE 2 | Withdrawn |
| 04-32-0623 | SIZE 3.5, TYPE 3 | Withdrawn |
| 04-34-0201 | SIZE 1 | Withdrawn |
| 04-32-0112 | SIZE 2, TYPE 2 | Withdrawn |
| 04-31-1106 | SIZE 6, RIGHT | Withdrawn |
| 04-33-0136 | Width 7.5 mm | Withdrawn |
| 04-31-1102 | SIZE 2, RIGHT | Withdrawn |
| 04-32-0612 | SIZE 2.5, TYPE 2 | Withdrawn |
| 04-31-2506 | SIZE 6, LEFT | Withdrawn |
| 04-34-0204 | SIZE 4 | Withdrawn |
| 04-34-0001 | SIZE 1 | Withdrawn |
| 04-32-0316 | SIZE 6, TYPE 2 | Withdrawn |
| 04-31-2001 | SIZE 1, LEFT | Withdrawn |
| 04-31-1304 | SIZE 4, RIGHT | Withdrawn |
| 04-31-2503 | SIZE 3, LEFT | Withdrawn |
| 04-32-0416 | SIZE 6, TYPE 2 | Withdrawn |
| 04-32-0005 | TYPE 1, SIZE 5 | Withdrawn |
| 04-32-0464 | SIZE 4, TYPE 0 | Withdrawn |
| 04-32-0466 | SIZE 6, TYPE 0 | Withdrawn |
| 04-33-0106 | Width 0 mm | Withdrawn |
| 04-31-2302 | SIZE 2, LEFT | Withdrawn |
| 04-32-0016 | SIZE 6, TYPE 2 | Withdrawn |
| 04-33-0113 | Width 2.5 mm | Withdrawn |
| 04-32-0321 | SIZE 1, TYPE 3 | Withdrawn |
| 04-31-1001 | SIZE 1, RIGHT | Withdrawn |
| 04-31-1506 | SIZE 6, RIGHT | Withdrawn |
| 04-31-2003 | SIZE 3, LEFT | Withdrawn |
| 04-34-0005 | SIZE 5 | Withdrawn |
| 04-32-0863 | SIZE 3.5, TYPE 0 | Withdrawn |
| 04-32-0601 | SIZE 1.5, TYPE 1 | Withdrawn |
| 04-32-0302 | SIZE 2, TYPE 1 | Withdrawn |
| 04-32-0463 | SIZE 3, TYPE 0 | Withdrawn |
| 04-32-0421 | SIZE 1, TYPE 3 | Withdrawn |
| 04-34-0202 | SIZE 2 | Withdrawn |
| 04-32-0615 | SIZE 5.5, TYPE 2 | Withdrawn |
| 04-32-0022 | SIZE 2, TYPE 3 | Withdrawn |
| 04-32-0024 | SIZE 4, TYPE 3 | Withdrawn |
| 04-32-0424 | SIZE 4, TYPE 3 | Withdrawn |
| 04-33-0125 | Width 5 mm | Withdrawn |
| 04-32-0425 | SIZE 5 TYPE 3 | Withdrawn |
| 04-32-0326 | SIZE 6, TYPE 3 | Withdrawn |
| 04-32-0061 | SIZE 1, TYPE 0 | Withdrawn |
| 04-32-0313 | SIZE 3, TYPE 2 | Withdrawn |
| 04-32-0063 | SIZE 3, TYPE 0 | Withdrawn |
| 04-32-0805 | SIZE 5.5, TYPE 1 | Withdrawn |
| 04-32-0665 | SIZE 5.5, TYPE 0 | Withdrawn |
| 04-32-0011 | TYPE 2, SIZE 1 | Withdrawn |
| 04-32-0164 | SIZE 4, TYPE 0 | Withdrawn |
| 04-33-0111 | Width 2.5 mm | Withdrawn |
| 04-31-2305 | SIZE 5, LEFT | Withdrawn |
| 04-32-0403 | SIZE 3, TYPE 1 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Prophecy® | Microport Orthopedics Inc. | 4,423 |
| Exult Knee Replacement System | Corentec Co., Ltd. | 1,770 |
| Freedom | Maxx Orthopedics Inc. | 1,693 |
| Legion | Smith & Nephew, Inc. | 1,534 |
| MyKnee | Medacta International SA | 1,466 |
| Journey | Smith & Nephew, Inc. | 1,339 |
| Persona® | Zimmer, Inc. | 1,254 |
| DJO Surgical | Encore Medical, L.P. | 1,131 |
| U2 Total Knee System | United Orthopedic Corp. | 1,078 |
| CKS Plus | Shalby Advanced Technologies, Inc. | 1,024 |
| Lospa Modular Knee System | Corentec Co., Ltd. | 1,020 |
| Natural-Knee® | Zimmer, Inc. | 980 |
Showing 12 of 1,175. All products under Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K081400 | 2009-02-20 |
| K012702 | 2002-01-30 |
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 |
|---|---|---|---|---|---|---|---|
| Endotec, Inc. | 510(k) number | 2009-06-05 | Not classified | Other | Endotec is recalling B-P Hip, B-P Shoulder, and B-P Knee Replacement System devices due to sterility issues involving validation, process variations and test results. | 3169 Pieces | 2013-10-22 |
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 |
|---|---|---|---|---|---|
| 2009-06-05 | Not classified | Other | Endotec is recalling B-P Hip, B-P Shoulder, and B-P Knee Replacement System devices due to sterility issues involving validation, process variations and test results. | 51 Pieces | 2013-10-22 |
| 2009-06-05 | Not classified | Other | Endotec is recalling B-P Hip, B-P Shoulder, and B-P Knee Replacement System devices due to sterility issues involving validation, process variations and test results. | 3 Pieces | 2013-10-22 |
| 2009-06-05 | Not classified | Other | Endotec is recalling B-P Hip, B-P Shoulder, and B-P Knee Replacement System devices due to sterility issues involving validation, process variations and test results. | 50 Pieces | 2013-10-22 |
| 2009-06-05 | Not classified | Other | Endotec is recalling B-P Hip, B-P Shoulder, and B-P Knee Replacement System devices due to sterility issues involving validation, process variations and test results. | 156 Pieces | 2013-10-22 |
| 2009-06-05 | Not classified | Other | Endotec is recalling B-P Hip, B-P Shoulder, and B-P Knee Replacement System devices due to sterility issues involving validation, process variations and test results. | 5 Pieces | 2013-10-22 |
| 2009-06-05 | Not classified | Other | Endotec is recalling B-P Hip, B-P Shoulder, and B-P Knee Replacement System devices due to sterility issues involving validation, process variations and test results. | 43 Pieces | 2013-10-22 |
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.