Arix Hand System Bone Plate
ARIX Hand System bone plates provide internal fixation of bones in the hand and wrist. They are used in procedures including fracture treatment, joint fusion, corrective osteotomy and…
ARIX Hand System bone plates provide internal fixation of bones in the hand and wrist. They are used in procedures including fracture treatment, joint fusion, corrective osteotomy and replantation, together with the system’s fixation screws.
The plate is made from pure titanium. Compatible ARIX Hand System screws are made from titanium alloy, forming the separate fastening components of the plate-and-screw system.
Preparation
The implants are intended for a single use and require sterilization at the hospital before implantation.
22manufacturers in China registered for this device type
311catalogue numbers in this listing
24510(k) clearances naming this product code
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) | K131566 |
| Record published | 2016-07-07 |
| Record revised | 2025-11-20 (version 9) |
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 | Per pack | Status |
|---|---|---|---|
| H2-ST-104-CP | 10 | In distribution | |
| H2-SQ-304-R | 10 | In distribution | |
| H2-ST-105-CP | 10 | In distribution | |
| H2-QD-106 | In distribution | ||
| H2L-LL-006-13 | 10 | In distribution | |
| H1-QD-408-R | In distribution | ||
| H1-LL-005 | 10 | In distribution | |
| H2L-ST-006 | 5 | In distribution | |
| H2L-QD-008 | 5 | In distribution | |
| H1-TP-011 | In distribution | ||
| H1L-PL-005 | 5 | In distribution | |
| H2-QD-306-R | 5 | In distribution | |
| H2L-ST-104-13 | In distribution | ||
| H2L-LL-006-13 | 5 | In distribution | |
| H2-SQ-204 | 10 | In distribution | |
| H2-QD-108 | 5 | In distribution | |
| H1-PL-005 | 5 | In distribution | |
| H2-QD-112 | 5 | In distribution | |
| H2-QD-006 | 5 | In distribution | |
| H2L-ST-208-13 | 10 | In distribution | |
| H2-QD-106 | 5 | In distribution | |
| H2L-TP-007 | 10 | In distribution | |
| H2-ST-216 | In distribution | ||
| H1L-ST-016 | 10 | In distribution | |
| H2-LL-006-CP | 5 | In distribution | |
| H2L-ST-016 | 10 | In distribution | |
| H2-ST-106-CP | 10 | In distribution | |
| H1-QD-106 | In distribution | ||
| H1-QD-206-R | 5 | In distribution | |
| H2L-LL-010-13 | In distribution | ||
| H1-TP-007 | 5 | In distribution | |
| H1-YP-006A | In distribution | ||
| H1-QD-408-R | 10 | In distribution | |
| H1-QD-306-L | 5 | In distribution | |
| H1-ST-006 | In distribution | ||
| H2L-ST-104-13 | 10 | In distribution | |
| H1-TP-008 | 5 | In distribution | |
| H2L-LR-010-13 | 5 | In distribution | |
| H1L-QD-408-R | In distribution | ||
| H2L-ST-016 | 5 | In distribution | |
| H2L-YP-006 | 25 | In distribution | |
| H2-LL-006-CP | In distribution | ||
| H2-QD-206-L | 10 | In distribution | |
| H2-QD-306-L | 5 | In distribution | |
| H1L-TP-011 | 5 | In distribution | |
| H1L-ST-006 | In distribution | ||
| H1-SQ-204 | 5 | In distribution | |
| H1-PR-005 | 10 | In distribution | |
| H1-ZZ-016 | 10 | In distribution | |
| H1-QD-306-L | 10 | In distribution | |
| H2-TP-011 | In distribution | ||
| H2L-LR-006 | 15 | In distribution | |
| H2-QD-110 | 10 | In distribution | |
| H2L-TP-006-13 | In distribution | ||
| H2-LR-006 | In distribution | ||
| H2L-ST-105-13 | 10 | In distribution | |
| H1L-QD-408-L | In distribution | ||
| H1-QD-110 | In distribution | ||
| H2-QD-110 | 5 | In distribution | |
| H1-QD-306-R | 5 | In distribution | |
| H1-QD-206-R | In distribution | ||
| H2L-QD-006 | 5 | In distribution | |
| H2L-TP-010-13 | 5 | In distribution | |
| H1-HK-001 | In distribution | ||
| H1-ZZ-016 | In distribution | ||
| H2-TP-012 | In distribution | ||
| H2-ST-016 | 5 | In distribution | |
| H1L-TP-012 | 5 | In distribution | |
| H2L-ST-006 | 10 | In distribution | |
| H1L-ST-016 | 5 | In distribution | |
| H2L-QD-008 | In distribution | ||
| H1L-LL-005 | In distribution | ||
| H1-TP-007 | In distribution | ||
| H2-ST-216 | 10 | In distribution | |
| H1L-QD-408-R | 5 | In distribution | |
| H1L-TP-012 | In distribution | ||
| H1-ST-016 | 10 | In distribution | |
| H2-ST-006 | 5 | In distribution | |
| H1L-PL-005 | 10 | In distribution | |
| H2L-TP-010-13 | In distribution | ||
| H1-TP-012 | 10 | In distribution | |
| H2L-LL-006 | 15 | In distribution | |
| H1L-ST-104 | In distribution | ||
| H1-QD-110 | 10 | In distribution | |
| H1-TP-011 | 5 | In distribution | |
| H2L-LL-006 | 5 | In distribution | |
| H1-QD-106 | 5 | In distribution | |
| H2-QD-408-R | In distribution | ||
| H2-SQ-104 | 10 | In distribution | |
| H2L-LR-006-13 | In distribution | ||
| H1-QD-108 | In distribution | ||
| H2-TP-006 | In distribution | ||
| H1-QD-408-L | 5 | In distribution | |
| H1L-QD-408-L | 5 | In distribution | |
| H2-QD-408-L | 10 | In distribution | |
| H1-SQ-104 | In distribution | ||
| H1-QD-112 | 5 | In distribution | |
| H2-PL-006 | 10 | In distribution | |
| H2L-TP-007 | 5 | In distribution | |
| H1L-QD-112 | 5 | In distribution | |
| H2-QD-006 | 10 | In distribution | |
| H2-LR-010-CP | 5 | In distribution | |
| H2-PR-006 | 5 | In distribution | |
| H1-QD-108 | 10 | In distribution | |
| H2-QD-006 | In distribution | ||
| H1L-PL-005 | In distribution | ||
| H2-LL-006-CP | 10 | In distribution | |
| H2L-ST-004 | 5 | In distribution | |
| H2L-ST-104-13 | 5 | In distribution | |
| H2L-LR-006 | 25 | In distribution | |
| H1-QD-206-R | 10 | In distribution | |
| H1L-TP-011 | In distribution | ||
| H2-ST-104-CP | 5 | In distribution | |
| H2L-LR-006-13 | 5 | In distribution | |
| H1-LR-005 | 10 | In distribution | |
| H1-YP-006A | 10 | In distribution | |
| H2L-YP-006 | In distribution | ||
| H2-ST-104 | In distribution | ||
| H2L-YP-007 | 10 | In distribution | |
| H2-QD-106 | 10 | In distribution | |
| H2L-YP-006 | 5 | In distribution | |
| H2L-ST-016 | In distribution | ||
| H1-QD-206-L | 10 | In distribution | |
| H2L-LR-010-13 | In distribution | ||
| H2-QD-306-L | In distribution | ||
| H2-ST-016 | In distribution | ||
| H2-ST-106-CP | In distribution | ||
| H2L-LL-006-13 | In distribution | ||
| H2-SQ-104 | 5 | In distribution | |
| H2L-LR-006 | In distribution | ||
| H1-ST-216 | In distribution | ||
| H2L-TP-007 | In distribution | ||
| H2L-LR-006-13 | 10 | In distribution | |
| H1-YP-006A | 5 | In distribution | |
| H2-LL-010-CP | 5 | In distribution | |
| H2-QD-306-L | 10 | In distribution | |
| H1-QD-112 | In distribution | ||
| H2L-YP-007 | 5 | In distribution | |
| H2-PR-006 | 10 | In distribution | |
| H1-SQ-004 | 10 | In distribution | |
| H1-ST-216 | 10 | In distribution | |
| H2-ST-104 | 5 | In distribution | |
| H2L-ST-004 | 10 | In distribution | |
| H1L-TP-008 | 5 | In distribution | |
| H2-ST-208-CP | 5 | In distribution | |
| H1-PR-005 | In distribution | ||
| H2-SQ-304-L | In distribution | ||
| H1-TP-007 | 10 | In distribution | |
| H2-LL-010-CP | In distribution | ||
| H2-QD-408-L | In distribution | ||
| H2-QD-306-R | 10 | In distribution | |
| H1-ST-104 | In distribution | ||
| H1-PL-005 | 10 | In distribution | |
| H1-SQ-104 | 10 | In distribution | |
| H1L-LR-005 | In distribution | ||
| H1-LL-005 | 5 | In distribution | |
| H2-TP-007 | In distribution | ||
| H1-TP-010 | 5 | In distribution | |
| H2-ST-208-CP | In distribution | ||
| H1L-YP-006 | 5 | In distribution | |
| H2-ST-104-CP | In distribution | ||
| H1-QD-106 | 10 | In distribution | |
| H1L-ST-016 | In distribution | ||
| H2L-ST-208-13 | In distribution | ||
| H2L-LR-006 | 10 | In distribution | |
| H2L-ST-106-13 | In distribution | ||
| H2L-QD-008 | 10 | In distribution | |
| H1-TP-008 | In distribution | ||
| H1-QD-306-L | In distribution | ||
| H2-LR-006-CP | In distribution | ||
| H1-ST-104 | 10 | In distribution | |
| H2-LR-006 | 5 | In distribution | |
| H1L-ST-104 | 10 | In distribution | |
| H1-QD-408-L | In distribution | ||
| H2L-LL-010-13 | 10 | In distribution | |
| H1-TP-012 | 5 | In distribution | |
| H1-YP-006 | 5 | In distribution | |
| H2-QD-108 | In distribution | ||
| H2-LL-006 | 10 | In distribution | |
| H2-TP-006-CP | In distribution | ||
| H2L-YP-006 | 50 | In distribution | |
| H2-SQ-204 | In distribution | ||
| H1L-QD-408-L | 10 | In distribution | |
| H2-LR-010-CP | In distribution | ||
| H2L-LL-006 | 25 | In distribution | |
| H2-QD-408-R | 10 | In distribution | |
| H2L-TP-008 | In distribution | ||
| H2-QD-206-L | 5 | In distribution | |
| H2-LR-006-CP | 10 | In distribution | |
| H2L-ST-006 | In distribution | ||
| H2-ST-208-CP | 10 | In distribution | |
| H2-LR-006-CP | 5 | In distribution | |
| H1-YP-006 | In distribution | ||
| H1-QD-110 | 5 | In distribution | |
| H2-QD-306-R | In distribution | ||
| H1L-TP-012 | 10 | In distribution | |
| H1L-QD-408-R | 10 | In distribution | |
| H1L-LL-005 | 5 | In distribution | |
| H2-LR-006 | 10 | In distribution | |
| H2-ST-104 | 10 | In distribution | |
| H2-LL-006 | 5 | In distribution | |
| H1-QD-006 | 10 | In distribution | |
| H1-LR-005 | 5 | In distribution | |
| H1L-ST-006 | 10 | In distribution | |
| H2-YP-007 | In distribution | ||
| H2L-LL-006 | In distribution | ||
| H1-ST-216 | 5 | In distribution | |
| H1L-TP-007 | 5 | In distribution | |
| H1-QD-306-R | In distribution | ||
| H1L-QD-112 | 10 | In distribution | |
| H1-YP-006 | 10 | In distribution | |
| H2L-LR-010-13 | 10 | In distribution | |
| H2L-ST-004 | In distribution | ||
| H1-HK-001 | 10 | In distribution | |
| H2-ZZ-016 | In distribution | ||
| H1L-TP-007 | In distribution | ||
| H2L-LR-006 | 5 | In distribution | |
| H1-TP-012 | In distribution | ||
| H2-ST-006 | 10 | In distribution | |
| H1L-TP-011 | 10 | In distribution | |
| H1-TP-011 | 10 | In distribution | |
| H1-ST-006 | 5 | In distribution | |
| H2-QD-206-L | In distribution | ||
| H2L-LL-010-13 | 5 | In distribution | |
| H1-QD-206-L | In distribution | ||
| H1-TP-010 | 10 | In distribution | |
| H1-ST-016 | In distribution | ||
| H1L-TP-007 | 10 | In distribution | |
| H2L-ST-105-13 | In distribution | ||
| H2L-YP-006 | 15 | In distribution | |
| H1-ST-104 | 5 | In distribution | |
| H2-PR-006 | In distribution | ||
| H1-SQ-004 | 5 | In distribution | |
| H2-ST-006 | In distribution | ||
| H2-QD-112 | 10 | In distribution | |
| H2-SQ-304-L | 5 | In distribution | |
| H1-QD-006 | In distribution | ||
| H1L-TP-008 | 10 | In distribution | |
| H2-QD-206-R | 10 | In distribution | |
| H1L-LR-005 | 5 | In distribution | |
| H1-TP-008 | 10 | In distribution | |
| H1-LL-005 | In distribution | ||
| H1-SQ-204 | 10 | In distribution | |
| H2-SQ-104 | In distribution | ||
| H1L-PR-005 | 5 | In distribution | |
| H2-LL-010-CP | 10 | In distribution | |
| H2L-TP-010-13 | 10 | In distribution | |
| H2L-ST-105-13 | 5 | In distribution | |
| H2-TP-010-CP | In distribution | ||
| H2-SQ-304-L | 10 | In distribution |
Showing 250 of 300 catalogue numbers.
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.