Alians Fragment Specific
Alians Fragment Specific is a plate-and-screw fixation range for adult hand and forearm reconstruction. Its implants are used for fractures, osteotomies and arthrodesis of those regions.…
Alians Fragment Specific is a plate-and-screw fixation range for adult hand and forearm reconstruction. Its implants are used for fractures, osteotomies and arthrodesis of those regions.
The implant range uses titanium alloy and commercially pure titanium, with associated instruments supplied for the fixation procedure.
Preparation Options
Sterile Initial FS kits combine implants and instruments for single use. Separately supplied implants may be gamma-sterilized or nonsterile; nonsterile implants and instruments require preparation and sterilization by healthcare professionals before use.
Who Else Makes It
Concentrated in Jiangsu (10), Shanghai (4), Zhejiang (3). 12 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| 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 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
| Kingj Medical Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 7 |
| Hangzhou Sino-MIM Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 6 |
| Suzhou AND Science & Technology Development Corp. | Zhangjiagang | Jiangsu | Contract manufacturer | 5 |
| Beijing AK Medical Co., Ltd. | Changping District | Beijing | Contract manufacturer | 3 |
Showing 12 of 22. All 22 manufacturers in China registered for Plate, Fixation, Bone
Record
| Listed by | Newclip Technics SAS, France |
|---|---|
| FDA product code | HRS |
| Device type | Plate, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K170843 |
| Record published | 2024-11-14 |
| Record revised | 2025-11-20 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ETSIS4-ST | In distribution | |
| DTDRNS3 | In distribution | |
| KIT-XS4G | In distribution | |
| ETSIS1 | In distribution | |
| KIT-XN2G | In distribution | |
| DTDRNS1-ST | In distribution | |
| KIT-XN1D | In distribution | |
| KIT-XW3D | In distribution | |
| KIT-XEN1G | In distribution | |
| ETSIS2-ST | In distribution | |
| KIT-XES1D | In distribution | |
| KIT-XN3D | In distribution | |
| ETSIS4 | In distribution | |
| DTDRNS2-ST | In distribution | |
| KIT-XS2D | In distribution | |
| KIT-XN3G | In distribution | |
| DTDRNS2 | In distribution | |
| ETSIS1-ST | In distribution | |
| ETSIS3-ST | In distribution | |
| ETSIS3 | In distribution | |
| ETSIS2 | In distribution | |
| KIT-XW2G | In distribution | |
| KIT-XW3G | In distribution | |
| KIT-XEN1D | In distribution | |
| DTDRNS3-ST | In distribution | |
| KIT-XS1D | In distribution | |
| KIT-XS3D | In distribution | |
| KIT-XW2D | In distribution | |
| KIT-XS1G | In distribution | |
| KIT-XES1G | In distribution | |
| DTDRNS1 | In distribution | |
| KIT-XS2G | In distribution | |
| KIT-XS4D | In distribution | |
| KIT-XNS1G | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Pectus System | Biomet Microfixation | 4,662 |
| Arthrex® | Arthrex, Inc. | 3,031 |
| Evos | Smith & Nephew, Inc. | 2,235 |
| Peri-Loc | Smith & Nephew, Inc. | 2,196 |
| OsteoMed | Osteomed | 1,961 |
| VariAx | Stryker GmbH | 1,934 |
| Aptus | Medartis Inc. | 1,688 |
| TC-100 | Smith & Nephew, Inc. | 1,639 |
| Plate, Fixation, Bone | Synthes Gmbh | 1,613 |
| Anthem | Globus Medical, Inc. | 1,551 |
| Acumed | Acumed LLC | 1,360 |
| Signex | Osteonic Co., Ltd. | 1,310 |
Showing 12 of 3,530. All products under Plate, Fixation, Bone
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K261511 | 2026-07-28 |
| K261191 | 2026-07-08 |
| K261038 | 2026-05-29 |
| K253906 | 2026-03-11 |
| K250155 | 2025-04-23 |
| K241539 | 2024-07-30 |
| K221395 | 2022-07-01 |
| K202803 | 2021-12-16 |
| K213214 | 2021-11-24 |
| K202307 | 2020-11-17 |
| K173746 | 2018-02-27 |
| K173641 | 2018-01-16 |
| K171372 | 2018-01-04 |
| K171510 | 2017-09-08 |
| K170843 | 2017-06-16 |
| K170310 | 2017-03-30 |
| K161448 | 2016-10-31 |
| K152289 | 2016-08-17 |
| K141548 | 2015-01-30 |
| K143061 | 2015-01-26 |
| K142502 | 2014-12-23 |
| K130774 | 2013-06-19 |
| K100944 | 2010-10-22 |
| K063095 | 2006-12-22 |
| K061917 | 2006-08-28 |
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.