Plasma Coated NTK System
NTK Patella M/Back A
21manufacturers in China registered for this device type
65catalogue numbers in this listing
4recalls 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.
| 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 | Corin Limited, United Kingdom |
|---|---|
| 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, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K980545 |
| Record published | 2016-08-17 |
| Record revised | 2021-02-05 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Radiation Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 117.323P | In distribution | |
| 117.103P | In distribution | |
| 117.381P | In distribution | |
| 117.383P | In distribution | |
| 117.031P | In distribution | |
| 117.420P | In distribution | |
| 117.412P | In distribution | |
| 117.118P | In distribution | |
| 117.341P | In distribution | |
| 117.041P | In distribution | |
| 117.027P | In distribution | |
| 117.421P | In distribution | |
| 117.020P | In distribution | |
| 117.042P | In distribution | |
| 117.312P | In distribution | |
| 117.011P | In distribution | |
| 117.311P | In distribution | |
| 117.013P | In distribution | |
| 117.424P | In distribution | |
| 117.029P | In distribution | |
| 117.030P | In distribution | |
| 117.040P | In distribution | |
| 117.332P | In distribution | |
| 117.392P | In distribution | |
| 117.026P | In distribution | |
| 117.333P | In distribution | |
| 117.023P | In distribution | |
| 117.101P | In distribution | |
| 117.022P | In distribution | |
| 117.012P | In distribution | |
| 117.391P | In distribution | |
| 117.021P | In distribution | |
| 117.025P | In distribution | |
| 117.119P | In distribution | |
| 117.393P | In distribution | |
| 117.113P | In distribution | |
| 117.382P | In distribution | |
| 117.343P | In distribution | |
| 117.331P | In distribution | |
| 117.413P | In distribution | |
| 117.321P | In distribution | |
| 117.034P | In distribution | |
| 117.112P | In distribution | |
| 117.044P | In distribution | |
| 117.014P | In distribution | |
| 117.427P | In distribution | |
| 117.028P | In distribution | |
| 117.411P | In distribution | |
| 117.313P | In distribution | |
| 117.322P | In distribution | |
| 117.010P | In distribution | |
| 117.032P | In distribution | |
| 117.102P | In distribution | |
| 117.410P | In distribution | |
| 117.342P | In distribution | |
| 117.423P | In distribution | |
| 117.417P | In distribution | |
| 117.300P | In distribution | |
| 117.104P | In distribution | |
| 117.422P | In distribution | |
| 117.033P | In distribution | |
| 117.024P | In distribution | |
| 117.043P | In distribution | |
| 117.111P | In distribution | |
| 117.414P | In distribution |
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
Recalls
4 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2025-05-23 | Class II | Nonconforming Material/Component | Investigation has identified that the age of the nylon packaging material has caused a loss of integrity of some pouches. | 341 units | |
| 2023-10-13 | Class II | Process change control | Potential for Unity CR Inserts Right size 6 from batch 529803 to be incorrectly labelled as Unity CR Inserts Right size 7 from batch 532405 and visa versa. | 1 units | |
| 2023-10-13 | Class II | Process change control | Potential for Unity CR Inserts Right size 6 from batch 529803 to be incorrectly labelled as Unity CR Inserts Right size 7 from batch 532405 and visa versa. | 3 units | |
| 2022-10-31 | Class II | Under Investigation by firm | The internal packaging system for devices may have damage to the blisters potentially damaging the device or compromising the sterility of the packaging. | 4 devices | 2024-01-12 |
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.