Arthrex®
Volar Dist RAD PLT TI Narrow RT 3H, Strl
22manufacturers in China registered for this device type
3,031catalogue numbers in this listing
39510(k) clearances naming this product code
3recalls on this 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 | Arthrex, Inc., United States |
|---|---|
| FDA product code | HRS |
| Device type | Plate, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Manufacturer, Exporter |
| Record published | 2019-03-20 |
| Record revised | 2026-05-12 (version 30) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Distribution end date | 2024-08-07 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AR-8730-42H | In distribution | |
| AR-8945-75FT | In distribution | |
| AR-13400L-11 | In distribution | |
| AR-8916VNR-03S | In distribution | |
| AR-8545-24S | In distribution | |
| AR-9943T-05S | In distribution | |
| AR-8963P-10 | In distribution | |
| AR-13200M-07RS | In distribution | |
| AR-8007-20 | In distribution | |
| AR-8730-54HS | In distribution | |
| AR-8954ML-L | In distribution | |
| AR-8952ML-07RST | In distribution | |
| AR-2665-24 | In distribution | |
| AR-8954MR-LS | In distribution | |
| AR-8008-30 | In distribution | |
| AR-8916VNC-24 | In distribution | |
| AR-8545-32S | In distribution | |
| AR-9953UH-05 | In distribution | |
| AR-13380-40 | In distribution | |
| AR-8943DL-04 | In distribution | |
| AR-8967-2895S | In distribution | |
| AR-8916VNL-03 | In distribution | |
| AR-8967-18115S | In distribution | |
| AR-8545-38S | In distribution | |
| AR-8545L-18S | In distribution | |
| AR-8963APLL-12 | In distribution | |
| AR-9943C-04 | In distribution | |
| AR-8954YR-LS | In distribution | |
| AR-8730-20HS | In distribution | |
| AR-8963MR-09 | In distribution | |
| AR-8916VNC-10S | In distribution | |
| AR-9060-55PTS | In distribution | |
| AR-18716V-20 | In distribution | |
| AR-8952MT-07S | In distribution | |
| AR-8555-80S | In distribution | |
| AR-13200ST-12.5 | In distribution | |
| AR-8916VNC-16S | In distribution | |
| AR-8970AR-06 | In distribution | |
| AR-8963MR-12S | In distribution | |
| AR-8952MS-03 | In distribution | |
| AR-8935CL-24 | In distribution | |
| AR-13730-03 | In distribution | |
| AR-8770-90HS | In distribution | |
| AR-13730-02 | In distribution | |
| AR-8725-14HS | In distribution | |
| AR-13070M | In distribution | |
| AR-8735-12 | In distribution | |
| AR-8916CX24-28S | In distribution | |
| AR-8740-46HS | In distribution | |
| AR-8835CL-46S | In distribution | |
| AR-8945-75FTS | In distribution | |
| AR-8933HV-70 | In distribution | |
| AR-2665-22 | In distribution | |
| AR-8967-28110 | In distribution | |
| AR-8916VWR-03 | In distribution | |
| AR-7654EL-15S | In distribution | |
| AR-13200M-02LS | In distribution | |
| AR-8945-65PTS | In distribution | |
| AR-8935-70 | In distribution | |
| AR-8954ML-SS | In distribution | |
| AR-8725-46HS | In distribution | |
| AR-8924VSL-09S | In distribution | |
| AR-8941PRS-ST | In distribution | |
| AR-8827CL-40S | In distribution | |
| AR-9944S-0R | In distribution | |
| AR-8967-100FT | In distribution | |
| AR-8916VNL-07S | In distribution | |
| AR-8827VCL-20 | In distribution | |
| AR-1588-60BT | In distribution | |
| AR-8916VSR-07S | In distribution | |
| AR-9943BR-10S | In distribution | |
| AR-9944X-5R | In distribution | |
| AR-2685DL-10 | In distribution | |
| AR-9954LHR-08S | In distribution | |
| AR-13200M-065LS | In distribution | |
| AR-13401-40 | In distribution | |
| AR-8952XMS | In distribution | |
| AR-2665-22H | In distribution | |
| AR-8945-35FT | In distribution | |
| AR-8827-22 | In distribution | |
| AR-8935L-46 | In distribution | |
| AR-13070L | In distribution | |
| AR-8835VCL-38 | In distribution | |
| AR-8935-85S | In distribution | |
| AR-8827-12 | In distribution | |
| AR-8943DR-12S | In distribution | |
| AR-8724V-14 | In distribution | |
| AR-8952TT-03 | In distribution | |
| AR-8942R-MS | In distribution | |
| AR-8730-44H | In distribution | |
| AR-18827P-07 | In distribution | |
| AR-8725-28HS | In distribution | |
| AR-8835VCL-48 | In distribution | |
| AR-8952ML-08LST | In distribution | |
| AR-8944-P | In distribution | |
| AR-9944L-5L | In distribution | |
| AR-8952MS-07S | In distribution | |
| AR-8916VWL-05S | In distribution | |
| AR-8935-75 | In distribution | |
| AR-8931-20 | In distribution | |
| AR-8545-70S | In distribution | |
| AR-8935V-40 | In distribution | |
| AR-8916DNL-05ST | In distribution | |
| AR-8916CX24-75 | In distribution | |
| AR-9953UH-03 | In distribution | |
| AR-2622DR | In distribution | |
| AR-8943T-12 | In distribution | |
| AR-8970ARS | In distribution | |
| AR-13200PA-11.0 | In distribution | |
| AR-13200M-04RS | In distribution | |
| AR-13715-17.5 | In distribution | |
| AR-8730-60HS | In distribution | |
| AR-8944CR-PS | In distribution | |
| AR-8967-2845 | In distribution | |
| AR-8003-15S | In distribution | |
| AR-8725-24HS | In distribution | |
| AR-8935-42S | In distribution | |
| AR-8949-050 | In distribution | |
| AR-18716P-21 | In distribution | |
| AR-8827CL-50 | In distribution | |
| AR-8967-50FTS | In distribution | |
| AR-13715-09.0 | In distribution | |
| AR-8916VSL-07S | In distribution | |
| AR-9953UH-14S | In distribution | |
| AR-8827V-75 | In distribution | |
| AR-8740-65PTS | In distribution | |
| AR-8770-35HS | In distribution | |
| AR-8933V-60S | In distribution | |
| AR-8945-55PT | In distribution | |
| AR-8545-44S | In distribution | |
| AR-9954LL-16 | In distribution | |
| AR-8935L-52 | In distribution | |
| AR-8930-10 | In distribution | |
| AR-9055-40PTS | In distribution | |
| AR-8750-75H | In distribution | |
| AR-8827VCL-70 | In distribution | |
| AR-8835VCL-42 | In distribution | |
| AR-8827V-15 | In distribution | |
| AR-8916RSTY-05ST | In distribution | |
| AR-8916VNC-32 | In distribution | |
| AR-2656DL | In distribution | |
| AR-8835CL-20 | In distribution | |
| AR-8835V-58 | In distribution | |
| AR-8967-1860S | In distribution | |
| AR-13380-54 | In distribution | |
| AR-8963ARF-07 | In distribution | |
| AR-8967-18110 | In distribution | |
| AR-8963MR-04S | In distribution | |
| AR-8935CL-38S | In distribution | |
| AR-8916VNC-12 | In distribution | |
| AR-8963ARF-08S | In distribution | |
| AR-8963AL-09 | In distribution | |
| AR-9943T-07 | In distribution | |
| AR-14122 | In distribution | |
| AR-8967-1880S | In distribution | |
| AR-7657-07 | In distribution | |
| AR-8916DSR-04ST | In distribution | |
| AR-8963ARF-05 | In distribution | |
| AR-8945-32FT | In distribution | |
| AR-8827L-58 | In distribution | |
| AR-8933-36S | In distribution | |
| AR-8927VCL-58 | In distribution | |
| AR-8927VCL-50 | In distribution | |
| AR-8963AR-06 | In distribution | |
| AR-8827L-40 | In distribution | |
| AR-7657-22S | In distribution | |
| AR-9954MR-10S | In distribution | |
| AR-8967-2885 | In distribution | |
| AR-8963APLR-14 | In distribution | |
| AR-8963PLL-05S | In distribution | |
| AR-8750-65H | In distribution | |
| AR-8770-65HS | In distribution | |
| AR-8935CL-12S | In distribution | |
| AR-8924VSR-05 | In distribution | |
| AR-8935V-55 | In distribution | |
| AR-8555-35 | In distribution | |
| AR-8771-0430S | In distribution | |
| AR-8963PLL-04S | In distribution | |
| AR-8924VNL-03DS-CP | In distribution | |
| AR-7657-14 | In distribution | |
| AR-8935CL-40S | In distribution | |
| AR-8555-20S | In distribution | |
| AR-8953-05S | In distribution | |
| AR-8935CL-38 | In distribution | |
| AR-8935-58S | In distribution | |
| AR-18827P-46 | In distribution | |
| AR-8970TT-05 | In distribution | |
| AR-8827CL-42 | In distribution | |
| AR-9953AL-15S | In distribution | |
| AR-8735-10S | In distribution | |
| AR-8933V-55 | In distribution | |
| AR-8730-34H | In distribution | |
| AR-18827V-15 | In distribution | |
| AR-8730-20H | In distribution | |
| AR-8724V-30S | In distribution | |
| AR-8933L-32 | In distribution | |
| AR-2652CLS | In distribution | |
| AR-2665-12H | In distribution | |
| AR-8724L-22 | In distribution | |
| AR-8827CL-26 | In distribution | |
| AR-7657-09 | In distribution | |
| AR-8935V-18 | In distribution | |
| AR-9055-50PTS | In distribution | |
| AR-8967-18100 | In distribution | |
| AR-9943BR-04 | In distribution | |
| AR-8963ALF-12 | In distribution | |
| AR-2665-14 | In distribution | |
| AR-8724L-12 | In distribution | |
| AR-8835CL-28 | In distribution | |
| AR-8954PR-MS | In distribution | |
| AR-8967-120FT | In distribution | |
| AR-9954LHR-08 | In distribution | |
| AR-13200PA-07.5S | In distribution | |
| AR-8924VNL-05S | In distribution | |
| AR-13400L-08 | In distribution | |
| AR-8827-32 | In distribution | |
| AR-8944L-L | In distribution | |
| AR-8935V-110 | In distribution | |
| AR-8943DL-05 | In distribution | |
| AR-7651R-14 | In distribution | |
| AR-8916VNC-34S | In distribution | |
| AR-8933-40 | In distribution | |
| SP-13400-06 | In distribution | |
| AR-8916CX24-18S | In distribution | |
| AR-8935CL-54 | In distribution | |
| AR-8835CL-34S | In distribution | |
| AR-8943DR-06 | In distribution | |
| AR-8927VCL-10 | In distribution | |
| AR-13710-17.5 | In distribution | |
| AR-8827V-10 | In distribution | |
| AR-8740-20HS | In distribution | |
| AR-9933-14 | In distribution | |
| AR-13100-07.5 | In distribution | |
| AR-8935CL-42 | In distribution | |
| AR-8916VSL-09 | In distribution | |
| AR-13200M-03L | In distribution | |
| AR-9954LR-10S | In distribution | |
| AR-13200M-075L | In distribution | |
| AR-8916VNC-28S | In distribution | |
| AR-8935L-48S | In distribution | |
| AR-8827-18 | In distribution | |
| AR-9943T-05 | In distribution | |
| AR-13200M-045LS | In distribution | |
| AR-2651CRS | In distribution | |
| AR-8952MC-SRS | In distribution | |
| AR-8827V-16 | In distribution | |
| AR-9954LHL-14S | In distribution | |
| AR-13200ST-11.0 | In distribution | |
| AR-8916VNC-14S | In distribution | |
| AR-8935CL-32 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Pectus System | Biomet Microfixation | 4,662 |
| 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 |
| LCP | Synthes Gmbh | 1,295 |
Showing 12 of 3,530. All products under Plate, Fixation, Bone
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K260353 | 2026-03-03 |
| K253713 | 2026-01-21 |
| K252807 | 2026-01-12 |
| K243995 | 2025-03-26 |
| K242079 | 2024-11-14 |
| K242554 | 2024-10-21 |
| K222267 | 2022-10-03 |
| K222244 | 2022-09-30 |
| K220937 | 2022-06-29 |
| K213837 | 2022-05-02 |
| K203834 | 2021-03-25 |
| K203294 | 2021-02-03 |
| K201677 | 2020-09-02 |
| K201132 | 2020-07-27 |
| K193345 | 2020-07-08 |
| K201235 | 2020-07-06 |
| K190953 | 2019-10-16 |
| K191326 | 2019-10-15 |
| K191344 | 2019-10-03 |
| K170547 | 2017-09-01 |
| K151732 | 2015-08-28 |
| K150456 | 2015-04-29 |
| K143749 | 2015-04-03 |
| K143139 | 2015-01-16 |
| K141735 | 2014-08-15 |
| K141478 | 2014-07-08 |
| K130510 | 2013-09-25 |
| K131474 | 2013-07-03 |
| K123241 | 2013-04-05 |
| K111253 | 2011-08-02 |
| K062747 | 2006-09-29 |
| K052901 | 2005-12-12 |
| K052614 | 2005-09-28 |
| K041965 | 2004-09-08 |
| K040907 | 2004-07-01 |
| K031666 | 2003-11-18 |
| K032187 | 2003-09-22 |
| K014155 | 2002-03-18 |
| K973812 | 1998-06-10 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Arthrex, Inc. | UDI-DI | 2020-06-24 | Class II | Process control | Screws provided in packaging are 5mm shorter than intended | 28 units | 2021-02-16 |
| Arthrex, Inc. | UDI-DI | 2019-10-01 | Class II | Employee error | Screws provided in the device package are 6 mm longer than intended. | 20 units | 2021-09-08 |
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2021-03-11 | Class II | Under Investigation by firm | It was discovered that five AR-13200ST-15.0 parts were processed as AR-13200T-15.0 parts. | 32 units | 2024-10-29 |
| 2016-01-11 | Class II | Other | Potential for a component contained in the Implant System to be non-sterile. | 117 devices | 2019-07-24 |
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.