HLS Kneetec
61 catalogue numbers from GDI052, listed by Tornier Inc., United States, under Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer. 21 manufacturers in China are registered for this product code.
21manufacturers in China registered for this device type
61catalogue numbers in this listing
3510(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.
| 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 | Tornier 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 | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K094013 |
| Record published | 2015-10-16 |
| Record revised | 2019-12-11 (version 5) |
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 | expiry date, serial number |
| Distribution end date | 2017-11-30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| GDI052 | Size 2 | Withdrawn |
| GDI043 | Thickness 9 mm | Withdrawn |
| GDI005 | Size 5 | Withdrawn |
| GDI113 | Size 3 | Withdrawn |
| GDI085 | Size 5 | Withdrawn |
| GDI028 | Size 8 | Withdrawn |
| GDI025 | Size 5 | Withdrawn |
| GDI103 | Size 3 | Withdrawn |
| GDI023 | Size 3 | Withdrawn |
| GDI057 | Size 7/8 | Withdrawn |
| GDI065 | Size 5 | Withdrawn |
| GDI044 | Size 4 | Withdrawn |
| GDI045 | Thickness 9 mm | Withdrawn |
| GDI042 | Thickness 9 mm | Withdrawn |
| GDI063 | Size 3 | Withdrawn |
| GDI015 | Size 5 | Withdrawn |
| GDI115 | Size 5 | Withdrawn |
| GDI064 | Thickness 13 mm | Withdrawn |
| GDI024 | Size 4 | Withdrawn |
| GDI003 | Size 3 | Withdrawn |
| GDI026 | Size 6 | Withdrawn |
| GDI082 | Thickness 18 mm | Withdrawn |
| GDI105 | Size 5 | Withdrawn |
| GDI074 | Thickness 15 mm | Withdrawn |
| GDI114 | Size 4 | Withdrawn |
| GDI014 | Size 4 | Withdrawn |
| GDI056 | Thickness 11 mm | Withdrawn |
| GDI054 | Thickness 11 mm | Withdrawn |
| GDI017 | Size 7 | Withdrawn |
| GDI077 | Size 7/8 | Withdrawn |
| GDI084 | Thickness 18 mm | Withdrawn |
| GDI027 | Size 7 | Withdrawn |
| GDI096 | Size 6 | Withdrawn |
| GDI075 | Thickness 15 mm | Withdrawn |
| GDI055 | Size 5 | Withdrawn |
| GDI012 | Size 2 | Withdrawn |
| GDI104 | Size 4 | Withdrawn |
| GDI004 | Size 4 | Withdrawn |
| GDI067 | Size 7/8 | Withdrawn |
| GDI087 | Size 7/8 | Withdrawn |
| GDI062 | Thickness 13 mm | Withdrawn |
| GDI086 | Thickness 18 mm | Withdrawn |
| GDI046 | Size 6 | Withdrawn |
| GDI002 | Size 2 | Withdrawn |
| GDI093 | Thickness 21 mm | Withdrawn |
| GDI072 | Size 2 | Withdrawn |
| GDI083 | Size 3 | Withdrawn |
| GDI016 | Size 6 | Withdrawn |
| GDI097 | Thickness 21 mm | Withdrawn |
| GDI095 | Size 5 | Withdrawn |
| GDI076 | Thickness 15 mm | Withdrawn |
| GDI092 | Size 2 | Withdrawn |
| GDI013 | Size 3 | Withdrawn |
| GDI006 | Size 6 | Withdrawn |
| GDI073 | Thickness 15 mm | Withdrawn |
| GDI094 | Thickness 21 mm | Withdrawn |
| GDI007 | Size 7 | Withdrawn |
| GDI047 | Size 7/8 | Withdrawn |
| GDI053 | Size 3 | Withdrawn |
| GDI022 | Size 2 | Withdrawn |
| GDI066 | Thickness 13 mm | 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 |
|---|---|
| K094013 | 2011-05-05 |
| K032079 | 2003-10-02 |
| K013906 | 2002-07-17 |
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.