Consensus® Knee System

Patellar Component, Circular, All Poly, Cemented

Registry build 21.09.26
21manufacturers in China registered for this device type
650catalogue numbers in this listing
5510(k) clearances naming this product 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 Consensus® Knee System
Listed by Consensus Orthopedics, 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
Record published 2015-10-16
Record revised 2021-07-29 (version 4)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Latex Labelled latex-free
Label carries lot or batch number, expiry date
Distribution end date 2021-07-28
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Consensus® Knee System
Catalogue number Size Status
2765-0-0002 2 ,Numbers, proprietary sizes Withdrawn
2761-2-0003 3 ,Numbers, proprietary sizes Withdrawn
2251-0-0004 4 ,Numbers, proprietary sizes Withdrawn
2586-0-0003 3 ,Numbers, proprietary sizes Withdrawn
2351-0-0003 3 ,Numbers, proprietary sizes Withdrawn
2142-1-5618 5-6 ,Numbers, proprietary sizes Withdrawn
2767-0-1001 1 ,Numbers, proprietary sizes Withdrawn
2272-0-0001 1 ,Numbers, proprietary sizes Withdrawn
2582-0-0006 6 ,Numbers, proprietary sizes Withdrawn
2454-0-0005 5 ,Numbers, proprietary sizes Withdrawn
2761-2-0002 2 ,Numbers, proprietary sizes Withdrawn
2142-1-1214 1-2 ,Numbers, proprietary sizes Withdrawn
2352-0-0005 5 ,Numbers, proprietary sizes Withdrawn
2351-0-0004 4 ,Numbers, proprietary sizes Withdrawn
2246-0-3416 3-4 ,Numbers, proprietary sizes Withdrawn
2141-1-0020 0 ,Numbers, proprietary sizes Withdrawn
2352-0-0002 2 ,Numbers, proprietary sizes Withdrawn
2241-0-5614 5-6 ,Numbers, proprietary sizes Withdrawn
2142-1-0010 0 ,Numbers, proprietary sizes Withdrawn
2586-0-0002 2 ,Numbers, proprietary sizes Withdrawn
2245-0-3414 3-4 ,Numbers, proprietary sizes Withdrawn
2764-1-1003 3 ,Numbers, proprietary sizes Withdrawn
2351-0-0005 5 ,Numbers, proprietary sizes Withdrawn
2154-0-0001 1 ,Numbers, proprietary sizes Withdrawn
2561-1-0003 3 ,Numbers, proprietary sizes Withdrawn
2485-0-0001 1 ,Numbers, proprietary sizes Withdrawn
2142-0-1216 1-2 ,Numbers, proprietary sizes Withdrawn
2241-0-1216 1-2 ,Numbers, proprietary sizes Withdrawn
2488-0-0004 4 ,Numbers, proprietary sizes Withdrawn
2142-1-0022 0 ,Numbers, proprietary sizes Withdrawn
2452-0-0006 6 ,Numbers, proprietary sizes Withdrawn
2585-0-0000 0 ,Numbers, proprietary sizes Withdrawn
2488-0-0000 0 ,Numbers, proprietary sizes Withdrawn
2142-1-3418 3-4 ,Numbers, proprietary sizes Withdrawn
2584-0-0002 2 ,Numbers, proprietary sizes Withdrawn
2141-1-1220 1-2 ,Numbers, proprietary sizes Withdrawn
2771-1-0003 3 ,Numbers, proprietary sizes Withdrawn
2660-0-1016 1 ,Numbers, proprietary sizes Withdrawn
2586-0-0005 5 ,Numbers, proprietary sizes Withdrawn
2142-1-1210 1-2 ,Numbers, proprietary sizes Withdrawn
2487-0-0005 5 ,Numbers, proprietary sizes Withdrawn
2781-0-0005 5 ,Numbers, proprietary sizes Withdrawn
2481-0-0000 0 ,Numbers, proprietary sizes Withdrawn
2660-0-1010 1 ,Numbers, proprietary sizes Withdrawn
2041-0-1210 1-2 ,Numbers, proprietary sizes Withdrawn
2585-0-0006 6 ,Numbers, proprietary sizes Withdrawn
2771-2-0001 1 ,Numbers, proprietary sizes Withdrawn
2242-0-3412 3-4 ,Numbers, proprietary sizes Withdrawn
2141-1-1210 1-2 ,Numbers, proprietary sizes Withdrawn
2451-1-0005 5 ,Numbers, proprietary sizes Withdrawn
2374-0-0002 2 ,Numbers, proprietary sizes Withdrawn
2660-0-5012 5 ,Numbers, proprietary sizes Withdrawn
2142-0-1212 1-2 ,Numbers, proprietary sizes Withdrawn
2766-0-1002 2 ,Numbers, proprietary sizes Withdrawn
2245-0-0020 0 ,Numbers, proprietary sizes Withdrawn
2142-1-3422 3-4 ,Numbers, proprietary sizes Withdrawn
2142-1-3410 3-4 ,Numbers, proprietary sizes Withdrawn
2572-0-0002 2 ,Numbers, proprietary sizes Withdrawn
2245-0-5620 5-6 ,Numbers, proprietary sizes Withdrawn
2246-0-1210 1-2 ,Numbers, proprietary sizes Withdrawn
2764-0-7502 2 ,Numbers, proprietary sizes Withdrawn
2141-1-1216 1-2 ,Numbers, proprietary sizes Withdrawn
2765-0-0001 1 ,Numbers, proprietary sizes Withdrawn
2241-0-1210 1-2 ,Numbers, proprietary sizes Withdrawn
2762-2-0004 4 ,Numbers, proprietary sizes Withdrawn
2042-0-1212 1-2 ,Numbers, proprietary sizes Withdrawn
2042-0-3414 3-4 ,Numbers, proprietary sizes Withdrawn
2154-0-0004 4 ,Numbers, proprietary sizes Withdrawn
2481-0-0001 1 ,Numbers, proprietary sizes Withdrawn
2253-0-0001 1 ,Numbers, proprietary sizes Withdrawn
2041-0-0010 0 ,Numbers, proprietary sizes Withdrawn
2153-0-0003 3 ,Numbers, proprietary sizes Withdrawn
2142-1-5616 5-6 ,Numbers, proprietary sizes Withdrawn
2771-2-0004 4 ,Numbers, proprietary sizes Withdrawn
2246-0-0010 0 ,Numbers, proprietary sizes Withdrawn
2482-0-0004 4 ,Numbers, proprietary sizes Withdrawn
2152-0-0002 2 ,Numbers, proprietary sizes Withdrawn
2252-0-0003 3 ,Numbers, proprietary sizes Withdrawn
2245-0-0016 0 ,Numbers, proprietary sizes Withdrawn
2242-0-3418 3-4 ,Numbers, proprietary sizes Withdrawn
2762-2-0006 6 ,Numbers, proprietary sizes Withdrawn
2453-0-0006 6 ,Numbers, proprietary sizes Withdrawn
2242-0-1210 1-2 ,Numbers, proprietary sizes Withdrawn
2041-0-3412 3-4 ,Numbers, proprietary sizes Withdrawn
2241-0-5610 5-6 ,Numbers, proprietary sizes Withdrawn
2151-0-0005 5 ,Numbers, proprietary sizes Withdrawn
2245-0-5612 5-6 ,Numbers, proprietary sizes Withdrawn
2142-1-5614 5-6 ,Numbers, proprietary sizes Withdrawn
2482-0-0002 2 ,Numbers, proprietary sizes Withdrawn
2272-0-0004 4 ,Numbers, proprietary sizes Withdrawn
2487-0-0002 2 ,Numbers, proprietary sizes Withdrawn
2271-0-0002 2 ,Numbers, proprietary sizes Withdrawn
2782-0-0000 0 ,Numbers, proprietary sizes Withdrawn
2042-0-3410 3-4 ,Numbers, proprietary sizes Withdrawn
2253-0-0006 6 ,Numbers, proprietary sizes Withdrawn
2761-1-0003 3 ,Numbers, proprietary sizes Withdrawn
2141-0-5616 5-6 ,Numbers, proprietary sizes Withdrawn
2241-0-3412 3-4 ,Numbers, proprietary sizes Withdrawn
2771-0-0005 5 ,Numbers, proprietary sizes Withdrawn
2451-0-0005 5 ,Numbers, proprietary sizes Withdrawn
2141-1-3410 3-4 ,Numbers, proprietary sizes Withdrawn
2761-2-0005 5 ,Numbers, proprietary sizes Withdrawn
2252-0-0002 2 ,Numbers, proprietary sizes Withdrawn
2245-0-3420 3-4 ,Numbers, proprietary sizes Withdrawn
2352-0-0001 1 ,Numbers, proprietary sizes Withdrawn
2584-0-0001 1 ,Numbers, proprietary sizes Withdrawn
2142-1-0018 0 ,Numbers, proprietary sizes Withdrawn
2252-0-0001 1 ,Numbers, proprietary sizes Withdrawn
2761-0-0006 6 ,Numbers, proprietary sizes Withdrawn
2582-0-0004 4 ,Numbers, proprietary sizes Withdrawn
2660-0-2012 2 ,Numbers, proprietary sizes Withdrawn
2586-0-0000 0 ,Numbers, proprietary sizes Withdrawn
2042-0-1218 1-2 ,Numbers, proprietary sizes Withdrawn
2246-0-1212 1-2 ,Numbers, proprietary sizes Withdrawn
2561-0-0006 6 ,Numbers, proprietary sizes Withdrawn
2041-0-5618 5-6 ,Numbers, proprietary sizes Withdrawn
2246-0-3410 3-4 ,Numbers, proprietary sizes Withdrawn
2042-0-3418 3-4 ,Numbers, proprietary sizes Withdrawn
2141-1-5618 5-6 ,Numbers, proprietary sizes Withdrawn
2242-0-5620 5-6 ,Numbers, proprietary sizes Withdrawn
2142-1-0016 0 ,Numbers, proprietary sizes Withdrawn
2372-0-0004 4 ,Numbers, proprietary sizes Withdrawn
2660-0-1012 1 ,Numbers, proprietary sizes Withdrawn
2142-1-3412 3-4 ,Numbers, proprietary sizes Withdrawn
2242-0-5610 5-6 ,Numbers, proprietary sizes Withdrawn
2771-2-0006 6 ,Numbers, proprietary sizes Withdrawn
2142-1-3414 3-4 ,Numbers, proprietary sizes Withdrawn
2245-0-1220 1-2 ,Numbers, proprietary sizes Withdrawn
2485-0-0002 2 ,Numbers, proprietary sizes Withdrawn
2245-0-0012 0 ,Numbers, proprietary sizes Withdrawn
2142-1-1212 1-2 ,Numbers, proprietary sizes Withdrawn
2451-1-0002 2 ,Numbers, proprietary sizes Withdrawn
2562-0-0005 5 ,Numbers, proprietary sizes Withdrawn
2272-0-0006 6 ,Numbers, proprietary sizes Withdrawn
2562-1-0002 2 ,Numbers, proprietary sizes Withdrawn
2762-2-0003 3 ,Numbers, proprietary sizes Withdrawn
2761-2-0004 4 ,Numbers, proprietary sizes Withdrawn
2141-1-3420 3-4 ,Numbers, proprietary sizes Withdrawn
2241-0-0018 0 ,Numbers, proprietary sizes Withdrawn
2241-0-1220 1-2 ,Numbers, proprietary sizes Withdrawn
2141-1-3422 3-4 ,Numbers, proprietary sizes Withdrawn
2141-0-3410 3-4 ,Numbers, proprietary sizes Withdrawn
2246-0-5616 5-6 ,Numbers, proprietary sizes Withdrawn
2482-0-0006 6 ,Numbers, proprietary sizes Withdrawn
2762-1-0002 2 ,Numbers, proprietary sizes Withdrawn
2571-0-0003 3 ,Numbers, proprietary sizes Withdrawn
2141-1-0012 0 ,Numbers, proprietary sizes Withdrawn
2241-0-0022 0 ,Numbers, proprietary sizes Withdrawn
2771-1-0001 1 ,Numbers, proprietary sizes Withdrawn
2273-0-0002 2 ,Numbers, proprietary sizes Withdrawn
2242-0-5612 5-6 ,Numbers, proprietary sizes Withdrawn
2353-0-0002 2 ,Numbers, proprietary sizes Withdrawn
2252-1-0002 2 ,Numbers, proprietary sizes Withdrawn
2141-1-5614 5-6 ,Numbers, proprietary sizes Withdrawn
2660-0-2018 2 ,Numbers, proprietary sizes Withdrawn
2353-0-0001 1 ,Numbers, proprietary sizes Withdrawn
2246-0-5622 5-6 ,Numbers, proprietary sizes Withdrawn
2241-0-0010 0 ,Numbers, proprietary sizes Withdrawn
2771-2-0003 3 ,Numbers, proprietary sizes Withdrawn
2252-0-0004 4 ,Numbers, proprietary sizes Withdrawn
2772-0-0004 4 ,Numbers, proprietary sizes Withdrawn
2765-0-1001 1 ,Numbers, proprietary sizes Withdrawn
2041-0-1212 1-2 ,Numbers, proprietary sizes Withdrawn
2142-1-5610 5-6 ,Numbers, proprietary sizes Withdrawn
2586-0-0001 1 ,Numbers, proprietary sizes Withdrawn
2154-0-0002 2 ,Numbers, proprietary sizes Withdrawn
2353-0-0004 4 ,Numbers, proprietary sizes Withdrawn
2354-0-0005 5 ,Numbers, proprietary sizes Withdrawn
2583-0-0001 1 ,Numbers, proprietary sizes Withdrawn
2141-0-5618 5-6 ,Numbers, proprietary sizes Withdrawn
2242-0-0014 0 ,Numbers, proprietary sizes Withdrawn
2242-0-1216 1-2 ,Numbers, proprietary sizes Withdrawn
2453-0-0005 5 ,Numbers, proprietary sizes Withdrawn
2485-0-0003 3 ,Numbers, proprietary sizes Withdrawn
2041-0-1218 1-2 ,Numbers, proprietary sizes Withdrawn
2246-0-5610 5-6 ,Numbers, proprietary sizes Withdrawn
2372-0-0006 6 ,Numbers, proprietary sizes Withdrawn
2583-0-0005 5 ,Numbers, proprietary sizes Withdrawn
2764-0-1001 1 ,Numbers, proprietary sizes Withdrawn
2246-0-3420 3-4 ,Numbers, proprietary sizes Withdrawn
2142-0-3418 3-4 ,Numbers, proprietary sizes Withdrawn
2782-0-0003 3 ,Numbers, proprietary sizes Withdrawn
2452-1-0004 4 ,Numbers, proprietary sizes Withdrawn
2374-0-0003 3 ,Numbers, proprietary sizes Withdrawn
2242-0-3410 3-4 ,Numbers, proprietary sizes Withdrawn
2583-0-0003 3 ,Numbers, proprietary sizes Withdrawn
2252-0-0006 6 ,Numbers, proprietary sizes Withdrawn
2772-0-0006 6 ,Numbers, proprietary sizes Withdrawn
2354-0-0002 2 ,Numbers, proprietary sizes Withdrawn
2486-0-0004 4 ,Numbers, proprietary sizes Withdrawn
2782-0-0004 4 ,Numbers, proprietary sizes Withdrawn
2581-0-0000 0 ,Numbers, proprietary sizes Withdrawn
2153-0-0006 6 ,Numbers, proprietary sizes Withdrawn
2764-1-7502 2 ,Numbers, proprietary sizes Withdrawn
2351-0-0002 2 ,Numbers, proprietary sizes Withdrawn
2772-1-0002 2 ,Numbers, proprietary sizes Withdrawn
2142-1-3416 3-4 ,Numbers, proprietary sizes Withdrawn
2242-0-1212 1-2 ,Numbers, proprietary sizes Withdrawn
2154-0-0006 6 ,Numbers, proprietary sizes Withdrawn
2482-0-0001 1 ,Numbers, proprietary sizes Withdrawn
2452-1-0001 1 ,Numbers, proprietary sizes Withdrawn
2487-0-0004 4 ,Numbers, proprietary sizes Withdrawn
2761-0-0005 5 ,Numbers, proprietary sizes Withdrawn
2252-1-0003 3 ,Numbers, proprietary sizes Withdrawn
2142-1-0014 0 ,Numbers, proprietary sizes Withdrawn
2782-0-0002 2 ,Numbers, proprietary sizes Withdrawn
2452-1-0003 3 ,Numbers, proprietary sizes Withdrawn
2241-0-5620 5-6 ,Numbers, proprietary sizes Withdrawn
2153-0-0002 2 ,Numbers, proprietary sizes Withdrawn
2374-0-0006 6 ,Numbers, proprietary sizes Withdrawn
2487-0-0003 3 ,Numbers, proprietary sizes Withdrawn
2371-0-0002 2 ,Numbers, proprietary sizes Withdrawn
2581-0-0003 3 ,Numbers, proprietary sizes Withdrawn
2766-0-1001 1 ,Numbers, proprietary sizes Withdrawn
2042-0-1214 1-2 ,Numbers, proprietary sizes Withdrawn
2487-0-0000 0 ,Numbers, proprietary sizes Withdrawn
2582-0-0005 5 ,Numbers, proprietary sizes Withdrawn
2488-0-0001 1 ,Numbers, proprietary sizes Withdrawn
2351-0-0006 6 ,Numbers, proprietary sizes Withdrawn
2242-0-1222 1-2 ,Numbers, proprietary sizes Withdrawn
2765-1-1001 1 ,Numbers, proprietary sizes Withdrawn
2660-0-6016 6 ,Numbers, proprietary sizes Withdrawn
2041-0-3422 3-4 ,Numbers, proprietary sizes Withdrawn
2242-0-5614 5-6 ,Numbers, proprietary sizes Withdrawn
2274-0-0001 1 ,Numbers, proprietary sizes Withdrawn
2272-0-0003 3 ,Numbers, proprietary sizes Withdrawn
2781-0-0003 3 ,Numbers, proprietary sizes Withdrawn
2451-1-0004 4 ,Numbers, proprietary sizes Withdrawn
2762-2-0001 1 ,Numbers, proprietary sizes Withdrawn
2245-0-1210 1-2 ,Numbers, proprietary sizes Withdrawn
2253-0-0002 2 ,Numbers, proprietary sizes Withdrawn
2142-1-0020 0 ,Numbers, proprietary sizes Withdrawn
2571-0-0002 2 ,Numbers, proprietary sizes Withdrawn
2245-0-3416 3-4 ,Numbers, proprietary sizes Withdrawn
2041-0-5612 5-6 ,Numbers, proprietary sizes Withdrawn
2781-0-0002 2 ,Numbers, proprietary sizes Withdrawn
2660-0-5010 5 ,Numbers, proprietary sizes Withdrawn
2452-1-0002 2 ,Numbers, proprietary sizes Withdrawn
2452-0-0003 3 ,Numbers, proprietary sizes Withdrawn
2482-0-0003 3 ,Numbers, proprietary sizes Withdrawn
2246-0-3414 3-4 ,Numbers, proprietary sizes Withdrawn
2042-0-3412 3-4 ,Numbers, proprietary sizes Withdrawn
2761-0-0004 4 ,Numbers, proprietary sizes Withdrawn
2764-0-1002 2 ,Numbers, proprietary sizes Withdrawn
2254-0-0002 2 ,Numbers, proprietary sizes Withdrawn
2041-0-5620 5-6 ,Numbers, proprietary sizes Withdrawn
2582-0-0003 3 ,Numbers, proprietary sizes Withdrawn
2246-0-3418 3-4 ,Numbers, proprietary sizes Withdrawn
2153-0-0001 1 ,Numbers, proprietary sizes Withdrawn
2141-1-5612 5-6 ,Numbers, proprietary sizes Withdrawn

Showing 250 of 300 catalogue numbers.

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
K163167 2017-08-09
K160515 2016-12-19
K143725 2015-03-04
K133919 2014-07-14
K100542 2010-06-24

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