Arix Humerus System Bone Plate
The ARIX Humerus System Bone Plate is part of a plate-and-screw system for fractures, fracture dislocations, osteotomies, and nonunions of the proximal humerus, particularly in osteopenic…
The ARIX Humerus System Bone Plate is part of a plate-and-screw system for fractures, fracture dislocations, osteotomies, and nonunions of the proximal humerus, particularly in osteopenic bone.
The system’s plates vary in length and number of holes, while screws vary in length and diameter. Manual surgical instruments, including drivers, drill bits, and depth gauges, support implantation.
Material and Preparation
The system uses unalloyed titanium and titanium alloy; as supplied, it is non-sterile and requires sterilization by autoclave 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 | Jeil Medical Corporation, South Korea |
|---|---|
| FDA product code | HRS |
| Device type | Plate, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| Establishment | Manufacturer |
| 510(k) | K172008 |
| Record published | 2018-02-01 |
| Record revised | 2025-11-20 (version 10) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 35-PLHU-003-L | In distribution | |
| 35-PLHU-A01-L | In distribution | |
| 35-PLHU-005-R | In distribution | |
| 35-PLHU-111-R | In distribution | |
| 35-PLHU-004-L | In distribution | |
| 35-PLHU-S01-R | In distribution | |
| 35-PLHU-119-R | In distribution | |
| 35-PLHU-003-R | In distribution | |
| 35-PLHU-119-L | In distribution | |
| 35-PLHU-111-L | In distribution | |
| 35-PLHU-A01-R | In distribution | |
| 35-PLHU-005-L | In distribution | |
| 35-PLHU-S01-L | In distribution | |
| 35-PLHU-004-R | 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 |
|---|---|
| K242751 | 2025-05-30 |
| K231887 | 2023-12-14 |
| K231441 | 2023-07-17 |
| K230938 | 2023-05-03 |
| K221412 | 2022-11-22 |
| K221920 | 2022-08-24 |
| K202912 | 2020-10-29 |
| K201656 | 2020-09-15 |
| K193616 | 2020-03-04 |
| K191972 | 2019-11-12 |
| K181806 | 2018-11-20 |
| K180972 | 2018-10-03 |
| K172008 | 2017-12-01 |
| K170705 | 2017-09-21 |
| K170979 | 2017-08-17 |
| K170780 | 2017-08-14 |
| K170313 | 2017-07-27 |
| K171285 | 2017-07-24 |
| K161746 | 2016-09-21 |
| K161864 | 2016-08-02 |
| K151468 | 2016-01-14 |
| K132876 | 2013-12-18 |
| K131566 | 2013-11-04 |
| K131311 | 2013-09-05 |
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.