Arix Wrist System Bone Plate
ARIX Wrist System bone plates are used with compatible screws for rigid fixation around the radius or ulna. Radius components are intended for forearm fractures, osteotomies and…
ARIX Wrist System bone plates are used with compatible screws for rigid fixation around the radius or ulna. Radius components are intended for forearm fractures, osteotomies and arthrodesis; ulna components are intended for fractures and osteotomies of the ulna.
The plates are offered in different configurations, lengths and numbers of screw holes. Their variable-locking feature works with the system’s fixation screws to form the construct selected for the patient’s anatomy.
Fixation Components
The system includes locking and nonlocking screws and smooth pegs. Locking screws are available in 1.5- and 2.5-millimetre diameters, nonlocking screws in 2.5 millimetres and smooth pegs in 2 millimetres.
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) | K191972 |
| Record published | 2016-04-24 |
| 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 |
|---|---|---|
| 25-DLUL-005 | In distribution | |
| 25-DVRA-111-R | In distribution | |
| 25R-DVRA-211-L | In distribution | |
| 25-DVRA-209-R | In distribution | |
| 25-DVRA-309-R | In distribution | |
| 25-DDRA-208 | In distribution | |
| 25-DLUL-105 | In distribution | |
| 25-DVRA-310-R | In distribution | |
| 25J-DVRA-109-L | In distribution | |
| 25-DDRA-106 | In distribution | |
| 25-DVRA-211-L | In distribution | |
| 25-DVRA-210-R | In distribution | |
| 25-DDRA-107 | In distribution | |
| 25-DVRA-312-R | In distribution | |
| 25-DVRA-309-L | In distribution | |
| 25R-DVRA-110-R | In distribution | |
| 25R-DVRA-209-L | In distribution | |
| 25J-DVRA-110-R | In distribution | |
| 25V-DLUL-007-H3 | In distribution | |
| 25-DDRA-006 | In distribution | |
| 25-DVRA-110-L | In distribution | |
| 25J-DVRA-209-R | In distribution | |
| 25-DLUL-107 | In distribution | |
| 25V-DLUL-107-H3 | In distribution | |
| 25J-DVRA-110-L | In distribution | |
| 25-DVRA-211-R | In distribution | |
| 25-DVRA-009-L | In distribution | |
| 25-DVRA-311-R | In distribution | |
| 25-CAFU-006 | In distribution | |
| 25J-DVRA-109-R | In distribution | |
| 25-DVRA-011-L | In distribution | |
| 25-DDRA-207 | In distribution | |
| 25-DVRA-311-L | In distribution | |
| 25-DVRA-212-R | In distribution | |
| 25R-DVRA-110-L | In distribution | |
| 25V-DLUL-106-H1 | In distribution | |
| 25J-DVRA-108-L | In distribution | |
| 25J-DVRA-210-R | In distribution | |
| 25V-DLUL-006-H2 | In distribution | |
| 25-DVRA-009-R | In distribution | |
| 25-DVRA-111-L | In distribution | |
| 25R-DVRA-211-R | In distribution | |
| 25-DVRA-112-R | In distribution | |
| 25J-DVRA-211-R | In distribution | |
| 25-DVRA-109-R | In distribution | |
| 25J-DVRA-209-L | In distribution | |
| 25R-DVRA-209-R | In distribution | |
| 25-DVRA-109-L | In distribution | |
| 20-DUHK-008 | In distribution | |
| 25-DLUL-008 | In distribution | |
| 25-DVRA-210-L | In distribution | |
| 25-DVRA-212-L | In distribution | |
| 25-DVRA-011-R | In distribution | |
| 25-DVRA-310-L | In distribution | |
| 25-DDRA-206 | In distribution | |
| 25-DDRA-005 | In distribution | |
| 25-DVRA-112-L | In distribution | |
| 25-DVRA-312-L | In distribution | |
| 25-CAFU-007 | In distribution | |
| 25-DLUL-007 | In distribution | |
| 25-DVRA-110-R | In distribution | |
| 25J-DVRA-211-L | In distribution | |
| 25-DLUL-108 | In distribution | |
| 25-DVRA-209-L | In distribution | |
| 25V-DLUL-007-H2 | In distribution | |
| 25J-DVRA-108-R | In distribution | |
| 25J-DVRA-210-L | In distribution | |
| 25-DLUL-006 | In distribution | |
| 25V-DLUL-106-H2 | In distribution | |
| 25V-DLUL-006-H1 | In distribution | |
| 25V-DLUL-107-H2 | In distribution | |
| 25-DDRA-108 | In distribution | |
| 25R-DVRA-108-L | In distribution | |
| 25-DDRA-004 | In distribution | |
| 25R-DVRA-108-R | In distribution | |
| 25-DLUL-106 | 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.