Alians Elbow
Alians Elbow is a locking plate-and-screw system for fixation of distal-humerus and proximal-ulna fractures or osteotomies in adults. The plate-and-screw construct holds the affected…
Alians Elbow is a locking plate-and-screw system for fixation of distal-humerus and proximal-ulna fractures or osteotomies in adults. The plate-and-screw construct holds the affected elbow-region bone segments in the intended relationship.
Both plates and screws are color-anodized Ti-6Al-4V ELI titanium alloy. The system has separate supply formats for standard instruments and single-use sterile kits.
Standard and Initial O Supply
The standard system is supplied nonsterile for sterilization by healthcare professionals. Initial O kits are supplied sterile and contain one plate, screws and the single-use instruments needed for implantation. The sterile kit format combines the fixation components and their placement tools in one set.
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) | K152289 |
| Record published | 2024-11-15 |
| 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 |
|---|---|---|
| NTGL5-ST | In distribution | |
| NTDY1-ST | In distribution | |
| NTGQ2-ST | In distribution | |
| NTSM3-ST | In distribution | |
| NTGL3 | In distribution | |
| NTDQ2-ST | In distribution | |
| HTDPS1-ST | In distribution | |
| NTSM4 | In distribution | |
| NTSM3 | In distribution | |
| NTGQ5 | In distribution | |
| NTDL4 | In distribution | |
| NTDY3-ST | In distribution | |
| NTGY1 | In distribution | |
| HTSPN1 | In distribution | |
| HTDPS3-ST | In distribution | |
| HTGPS1 | In distribution | |
| HTSPN1-ST | In distribution | |
| NTGY3D-ST | In distribution | |
| NTDY2-ST | In distribution | |
| NTDL5 | In distribution | |
| NTGL1 | In distribution | |
| NTDL5-ST | In distribution | |
| NTDL3-ST | In distribution | |
| NTGL3-ST | In distribution | |
| NTGQ3-ST | In distribution | |
| NTDQ5 | In distribution | |
| HTGPS2 | In distribution | |
| NTGQ4 | In distribution | |
| NTGQ3 | In distribution | |
| NTGY1-ST | In distribution | |
| NTSM1 | In distribution | |
| NTDQ1 | In distribution | |
| NTDY2 | In distribution | |
| NTDQ1-ST | In distribution | |
| NTDY3 | In distribution | |
| HTDPS2-ST | In distribution | |
| NTDQ3-ST | In distribution | |
| NTGQ1-ST | In distribution | |
| HTGPS3-ST | In distribution | |
| NTGQ4-ST | In distribution | |
| NTDQ2 | In distribution | |
| NTGL4 | In distribution | |
| HTDPS1 | In distribution | |
| HTGPS3 | In distribution | |
| NTDL2 | In distribution | |
| NTGY2-ST | In distribution | |
| NTDQ4 | In distribution | |
| NTDQ3 | In distribution | |
| NTSM1-ST | In distribution | |
| NTDQ4-ST | In distribution | |
| NTGQ5-ST | In distribution | |
| HTGPS1-ST | In distribution | |
| HTDPS2 | In distribution | |
| NTGY3 | In distribution | |
| HTDPS3 | In distribution | |
| NTGL4-ST | In distribution | |
| HTGPS2-ST | In distribution | |
| NTGY2 | In distribution | |
| NTGL2 | In distribution | |
| NTGQ1 | In distribution | |
| NTSM2-ST | In distribution | |
| NTGL2-ST | In distribution | |
| NTDL3 | In distribution | |
| NTGY3-ST | In distribution | |
| NTGL1-ST | 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.