HLS UNI Evolution
20 catalogue numbers from GDU152, listed by Tornier Inc., United States, under Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer. 6 manufacturers in China are registered for this product code.
6manufacturers in China registered for this device type
20catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
Concentrated in Zhejiang (2), Jiangsu (2), Shanghai (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| 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 |
| Turnxon Precision Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 17 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
Record
| Listed by | Tornier Inc., United States |
|---|---|
| FDA product code | HSX |
| Device type | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3520 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K022211 |
| Record published | 2015-10-16 |
| Record revised | 2018-10-03 (version 4) |
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 | 2017-11-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| GDU152 | Thickness 9 mm | Withdrawn |
| GDU154 | Size 5 | Withdrawn |
| GDU144 | Thickness 11 mm | Withdrawn |
| GDU114 | Size 1 | Withdrawn |
| GDU112 | Size 1 | Withdrawn |
| GDU136 | Thickness 13 mm | Withdrawn |
| GDU126 | Size 2 | Withdrawn |
| GDU533 | Thickness 3 mm | Withdrawn |
| GDU116 | Thickness 13 mm | Withdrawn |
| GDU530 | Size 0 | Withdrawn |
| GDU142 | Thickness 9 mm | Withdrawn |
| GDU532 | Size 2 | Withdrawn |
| GDU122 | Thickness 9 mm | Withdrawn |
| GDU132 | Size 3 | Withdrawn |
| GDU534 | Size 4 | Withdrawn |
| GDU156 | Size 5 | Withdrawn |
| GDU124 | Size 2 | Withdrawn |
| GDU134 | Thickness 11 mm | Withdrawn |
| GDU146 | Size 4 | Withdrawn |
| GDU531 | Thickness 3 mm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Journey | Smith & Nephew, Inc. | 517 |
| Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | Ortho Development Corp. | 303 |
| BKS® Uni | Ortho Development Corp. | 240 |
| LinkSymphoKnee | Waldemar Link GmbH & Co. KG | 210 |
| Moto Partial Knee System | Medacta International SA | 205 |
| Arthrex® | Arthrex, Inc. | 199 |
| Stride | Smith & Nephew, Inc. | 190 |
| Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | Zimmer, Inc. | 175 |
| ZUK | Smith & Nephew, Inc. | 161 |
| Tahoe Uni Knee System | Shalby Advanced Technologies, Inc. | 134 |
| Moto Partial Knee System – Medial | Medacta International SA | 132 |
| Journey II | Smith & Nephew, Inc. | 119 |
Showing 12 of 171. All products under Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K120262 | 2012-07-25 |
| K022211 | 2003-05-22 |
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.