MTS Knee

Guide 90-SRK-300220 4 IN 1 AP Adjustment

Registry build 21.09.26
21manufacturers in China registered for this device type
54catalogue numbers in this listing

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 MTS Knee
Listed by Medtronic, 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
Establishment Specification developer, Repacker / relabeller, Manufacturer, Exporter
Premarket notification Exempt
Record published 2018-12-30
Record revised 2026-03-11 (version 7)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Prescription Prescription only
Label carries lot or batch number
Distribution end date 2020-04-21

Catalogue Numbers

Catalogue numbers for MTS Knee
Catalogue number Size Status
90-SRK-400013 In distribution
90-SRK-300500 In distribution
90-SRK-300023 In distribution
90-SRK-201012 In distribution
90-SRK-300001 In distribution
90-SRK-201300 In distribution
90-SRK-201011 In distribution
90-SRK-210101 Withdrawn
90-SRK-800040 Withdrawn
90-SRK-300220 Withdrawn
90-SRK-800030 Withdrawn
90-SRK-201310 Withdrawn
90-SRK-300002 Withdrawn
90-SRK-460013 Withdrawn
90-SRK-800011 Withdrawn
90-SRK-300206 Withdrawn
90-SRK-460021 Withdrawn
90-SRK-300203 Withdrawn
90-SRK-300420 Withdrawn
90-SRK-460023 Withdrawn
90-SRK-210104 Withdrawn
90-SRK-210106 Withdrawn
90-SRK-210102 Withdrawn
90-SRK-460012 Withdrawn
90-SRK-201002 Withdrawn
90-SRK-460024 Withdrawn
90-SRK-300204 Withdrawn
90-SRK-300202 Withdrawn
90-SRK-100050 Withdrawn
90-SRK-460022 Withdrawn
90-SRK-460014 Withdrawn
90-SRK-800013 Withdrawn
90-SRK-300210 Withdrawn
90-SRK-201000 Withdrawn
90-SRK-210105 Withdrawn
90-SRK-800020 Withdrawn
90-SRK-800031 Withdrawn
90-SRK-300410 Withdrawn
90-SRK-300201 Withdrawn
90-SRK-800033 Withdrawn
90-SRK-201101 Withdrawn
90-SRK-800014 Withdrawn
90-SRK-100000 Withdrawn
90-SRK-300011 Withdrawn
90-SRK-800012 Withdrawn
90-SRK-460011 Withdrawn
90-SRK-210103 Withdrawn
90-SRK-800015 Withdrawn
90-SRK-300020 Withdrawn
90-SRK-300012 Withdrawn
90-SRK-300205 Withdrawn
90-SRK-201221 Withdrawn
90-SRK-201222 Withdrawn
90-SRK-100010 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

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