B-P Total Knee System

B-P Knee Thick Modular Tibial Platform W/Screw, W/Biocoat, W/Ultracoat, Type 3, Size 5

Registry build 21.09.26
21manufacturers in China registered for this device type
246catalogue numbers in this listing
2510(k) clearances naming this product code
7recalls on this code

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.

Chinese manufacturers registered for FDA product code JWH
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

Regulatory record for B-P Total Knee System
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

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 numbers for B-P Total Knee System
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

Other products under the same FDA 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

FDA 510(k) clearances naming this product code
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.

Recalls naming the identifiers of B-P Total Knee System
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.

Recalls referencing this product code
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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer