Arthrex®
3.8x22mm Headless FibuLock® Scrw, SS, STR
9manufacturers in China registered for this device type
154catalogue numbers in this listing
16510(k) clearances naming this product code
1recall
Who Else Makes It
Concentrated in Jiangsu (4), Shanghai (3), Zhejiang (1). 4 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 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
| Suzhou Endophix Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 17 |
Record
| Listed by | Arthrex, Inc., United States |
|---|---|
| FDA product code | HTN |
| Device type | Washer, Bolt Nut |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2026-03-16 |
| Record revised | 2025-05-26 (version 20) |
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 |
| Packaging | Box of 5 |
| Distribution end date | 2025-05-26 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AR-8974R-38-130 | In distribution | |
| AR-8838H-50 | In distribution | |
| AR-8926T | In distribution | |
| AR-7820AC | In distribution | |
| 8041-050 | In distribution | |
| AR-8914DS | In distribution | |
| 8042-060 | In distribution | |
| AR-2270 | In distribution | |
| AR-8943C-05 | In distribution | |
| AR-8912DS | In distribution | |
| AR-8958-01 | In distribution | |
| AR-8943C-06 | In distribution | |
| AR-8838H-12 | In distribution | |
| AR-9925SS-BPK | In distribution | |
| 8041-115 | In distribution | |
| AR-9925T-BPK | In distribution | |
| AR-8921CDS | In distribution | |
| AR-7267 | In distribution | |
| AR-8943C-04 | In distribution | |
| AR-8974-2P | In distribution | |
| AR-8827H-10S | In distribution | |
| AR-8907DS | In distribution | |
| AR-9925SS-01 | In distribution | |
| AR-1698-CP | In distribution | |
| AR-8974-3P | In distribution | |
| AR-8906DS | In distribution | |
| AR-8943C-06S | In distribution | |
| AR-8838H-22S | In distribution | |
| AR-8827H-14 | In distribution | |
| 8041-055 | In distribution | |
| 8040-130 | In distribution | |
| AR-8827H-24 | In distribution | |
| AR-8925SS | In distribution | |
| 8042-125 | In distribution | |
| AR-8827H-36 | In distribution | |
| AR-9925SS | In distribution | |
| 8042-035 | In distribution | |
| AR-8943C-07 | In distribution | |
| AR-8943C-07S | In distribution | |
| AR-8838H-22 | In distribution | |
| AR-2658BLO | In distribution | |
| 8040-065 | In distribution | |
| 8041-065 | In distribution | |
| AR-8924SS | In distribution | |
| AR-7820SC-5 | In distribution | |
| AR-7268GBL-01 | In distribution | |
| AR-2371 | In distribution | |
| 8042-110 | In distribution | |
| 8042-075 | In distribution | |
| AR-8943C-08 | In distribution | |
| AR-8914P | In distribution | |
| AR-8943C-12 | In distribution | |
| AR-8827H-36S | In distribution | |
| 8040-125 | In distribution | |
| AR-2257-01 | In distribution | |
| AR-7000-18T | In distribution | |
| AR-8838H-16S | In distribution | |
| AR-2372BLO | In distribution | |
| AR-8838H-10S | In distribution | |
| AR-2271 | In distribution | |
| 8040-100 | In distribution | |
| AR-8974L-30-275 | In distribution | |
| AR-8974-3PS | In distribution | |
| AR-8959TDS | In distribution | |
| 8040-085 | In distribution | |
| AR-2257 | In distribution | |
| AR-7000KD | In distribution | |
| 8041-070 | In distribution | |
| AR-2370BL | In distribution | |
| AR-1367B | In distribution | |
| AR-7267T-1 | In distribution | |
| 8042-085 | In distribution | |
| AR-8974EC-3 | In distribution | |
| 8042-105 | In distribution | |
| AR-8943C-04S | In distribution | |
| AR-8959-01S | In distribution | |
| 8041-130 | In distribution | |
| 8040-105 | In distribution | |
| AR-8958TDS | In distribution | |
| 8041-085 | In distribution | |
| 8042-130 | In distribution | |
| AR-7820SB | In distribution | |
| 8041-125 | In distribution | |
| AR-2371BL | In distribution | |
| AR-8827H-40S | In distribution | |
| AR-8958-01S | In distribution | |
| AR-8838H-40S | In distribution | |
| AR-8958-02S | In distribution | |
| AR-9925T-01 | In distribution | |
| AR-8919DS | In distribution | |
| 8041-075 | In distribution | |
| AR-2370 | In distribution | |
| AR-7820TB | In distribution | |
| AR-2658BL | In distribution | |
| AR-8827H-28 | In distribution | |
| AR-8943C-11 | In distribution | |
| 8042-115 | In distribution | |
| AR-2374 | In distribution | |
| AR-8974R-30-180 | In distribution | |
| 8040-090 | In distribution | |
| AR-8917DS | In distribution | |
| AR-8924T | In distribution | |
| AR-8925T | In distribution | |
| AR-8838H-65 | In distribution | |
| 8041-095 | In distribution | |
| AR-8925SS-01 | In distribution | |
| 8042-040 | In distribution | |
| AR-8925T-01 | In distribution | |
| AR-8913DS | In distribution | |
| AR-8838H-24S | In distribution | |
| AR-8974DS | In distribution | |
| AR-7268 | In distribution | |
| AR-8919-SS | In distribution | |
| 8039-000 | In distribution | |
| 8042-100 | In distribution | |
| AR-7000KL | In distribution | |
| AR-8838H-65S | In distribution | |
| AR-8827H-12S | In distribution | |
| AR-7268GBL | In distribution | |
| AR-8838H-45 | In distribution | |
| AR-8943C-10 | In distribution | |
| AR-8943C-09 | In distribution | |
| AR-8943C-12S | In distribution | |
| 8040-110 | In distribution | |
| AR-8974L-30-130 | In distribution | |
| AR-9925T-W | In distribution | |
| AR-8838H-10 | In distribution | |
| AR-2264 | In distribution | |
| AR-7820SC-6 | In distribution | |
| AR-8958-02 | In distribution | |
| AR-8959-02S | In distribution | |
| 8041-120 | In distribution | |
| 8041-045 | In distribution | |
| AR-8974L-30-180 | In distribution | |
| AR-9925T | In distribution | |
| AR-8943C-08S | In distribution | |
| AR-7000-18S | In distribution | |
| AR-8911DS | In distribution | |
| AR-8943C-10S | In distribution | |
| AR-8926SS | In distribution | |
| AR-2258-03 | In distribution | |
| AR-8908DS | In distribution | |
| 8042-045 | In distribution | |
| AR-8827H-12 | In distribution | |
| AR-8838H-30 | In distribution | |
| AR-9925SS-W | In distribution | |
| AR-7268T | In distribution | |
| AR-8974-01R | In distribution | |
| AR-7267-1 | In distribution | |
| AR-8974EC-5 | In distribution | |
| 8042-080 | In distribution | |
| AR-8920CDS | In distribution | |
| AR-2257-02 | In distribution | |
| AR-8941F | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Washer, Bolt Nut | Zimmer, Inc. | 308 |
| MaxTorque™ | Tornier Inc. | 171 |
| Kyocera Medical Technologies, Inc. | Kyocera Medical Technologies, Inc. | 92 |
| Washer, Bolt Nut | Synthes Gmbh | 88 |
| A.l.p.s.® | Biomet Orthopedics | 67 |
| Variax | Stryker GmbH | 59 |
| Conmed | ConMed Corporation | 38 |
| Neoortho | Neoortho Produtos Ortopédicos S/A | 32 |
| Aptus | Medartis Inc. | 31 |
| AC Device | Lockdown Medical Limited | 31 |
| Evos | Smith & Nephew, Inc. | 28 |
| Axis | Extremity Medical, LLC | 26 |
Showing 12 of 304. All products under Washer, Bolt Nut
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K253727 | 2025-12-22 |
| K232755 | 2023-10-06 |
| K221485 | 2022-08-22 |
| K220947 | 2022-06-06 |
| K213644 | 2021-12-17 |
| K201522 | 2020-09-03 |
| K140328 | 2014-03-10 |
| K133275 | 2014-01-30 |
| K112437 | 2011-12-21 |
| K090107 | 2009-08-06 |
| K071978 | 2007-08-15 |
| K061925 | 2006-10-31 |
| K052776 | 2005-12-13 |
| K043145 | 2005-02-18 |
| K043248 | 2005-02-16 |
| K023119 | 2002-12-18 |
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Arthrex, Inc. | UDI-DI | 2016-08-12 | Class III | Packaging process control | The device was assembled incorrectly. Suture and washer were not assembled; components were placed loose in the package. | 45 devices | 2019-08-20 |
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.