HLS Uni Evolution
HLS uni Evolution Tibial component PE Size 4 Th11mm
6manufacturers in China registered for this device type
105catalogue numbers in this listing
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 | Corin Limited, United Kingdom |
|---|---|
| FDA product code | HSX |
| Device type | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3520 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K022211 |
| Record published | 2018-08-28 |
| Record revised | 2023-05-03 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam 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 |
|---|---|---|
| MDU604 | In distribution | |
| GDU551 | In distribution | |
| MDU136 | In distribution | |
| MDU112 | In distribution | |
| MDU234 | In distribution | |
| GDU553 | In distribution | |
| GDU554 | In distribution | |
| MDU721 | In distribution | |
| GDU144 | In distribution | |
| MDU709 | In distribution | |
| MDU731 | In distribution | |
| MDU734 | In distribution | |
| MDU722 | In distribution | |
| MDU737 | In distribution | |
| MDU122 | In distribution | |
| GDU156 | In distribution | |
| MDU156 | In distribution | |
| GDU132 | In distribution | |
| MDU713 | In distribution | |
| GDU126 | In distribution | |
| MDU246 | In distribution | |
| MDU214 | In distribution | |
| MDU723 | In distribution | |
| GDU122 | In distribution | |
| GDU550 | In distribution | |
| MDU252 | In distribution | |
| MDU708 | In distribution | |
| MDU707 | In distribution | |
| GDU114 | In distribution | |
| GDU136 | In distribution | |
| MDU704 | In distribution | |
| MDU507 | In distribution | |
| MDU605 | In distribution | |
| MDU706 | In distribution | |
| GDU124 | In distribution | |
| MDU232 | In distribution | |
| MDU134 | In distribution | |
| MDU226 | In distribution | |
| MDU116 | In distribution | |
| MDU740 | In distribution | |
| GDU134 | In distribution | |
| MDU711 | In distribution | |
| GDU142 | In distribution | |
| MDU506 | In distribution | |
| MDU712 | In distribution | |
| MDU556 | In distribution | |
| GDU116 | In distribution | |
| MDU703 | In distribution | |
| GDU154 | In distribution | |
| MDU739 | In distribution | |
| MDU224 | In distribution | |
| MDU602 | In distribution | |
| MDU710 | In distribution | |
| MDU533 | In distribution | |
| MDU142 | In distribution | |
| MDU555 | In distribution | |
| MDU132 | In distribution | |
| MDU742 | In distribution | |
| GDU530 | In distribution | |
| MDU114 | In distribution | |
| GDU532 | In distribution | |
| MDU144 | In distribution | |
| MDU124 | In distribution | |
| GDU152 | In distribution | |
| MDU154 | In distribution | |
| MDU735 | In distribution | |
| MDU518 | In distribution | |
| GDU533 | In distribution | |
| MDU254 | In distribution | |
| MDU603 | In distribution | |
| MDU741 | In distribution | |
| MDU601 | In distribution | |
| MDU256 | In distribution | |
| GDU146 | In distribution | |
| MDU534 | In distribution | |
| MDU222 | In distribution | |
| MDU146 | In distribution | |
| GDU531 | In distribution | |
| MDU212 | In distribution | |
| MDU738 | In distribution | |
| MDU531 | In distribution | |
| MDU600 | In distribution | |
| MDU242 | In distribution | |
| MDU724 | In distribution | |
| MDU532 | In distribution | |
| MDU736 | In distribution | |
| MDU511 | In distribution | |
| GDU112 | In distribution | |
| MVV062 | In distribution | |
| MDU216 | In distribution | |
| MDU500 | In distribution | |
| MDU732 | In distribution | |
| MDU152 | In distribution | |
| MDU701 | In distribution | |
| MDU244 | In distribution | |
| GDU552 | In distribution | |
| MDU236 | In distribution | |
| MDU501 | In distribution | |
| MDU705 | In distribution | |
| MDU733 | In distribution | |
| MDU919 | In distribution | |
| MDU714 | In distribution | |
| GDU534 | In distribution | |
| MDU126 | In distribution | |
| MDU905 | In distribution |
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
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.