Cannulated Femur Nail, Right
The I.T.S. cannulated femur nail is an intramedullary implant for stabilizing femoral fractures in adults. Its curved right-sided design follows the natural bow of the femur. The nail is…
The I.T.S. cannulated femur nail is an intramedullary implant for stabilizing femoral fractures in adults. Its curved right-sided design follows the natural bow of the femur. The nail is inserted from the proximal end over a calibrated guidewire.
Cross-screws secure the nail within the bone. The proximal region accepts 6.5-millimetre cortical screws, and the distal region accepts 4.7-millimetre screws. A distal slot permits dynamization, while an optional end cap closes the proximal end.
Listed Item
Cannulated Femur Nail, Right, D=12.0mm, L=300mm
Implant Material
The nail is made from Ti-6Al-4V titanium alloy with an anodized surface treatment and is supplied non-sterile. The cannulated femur nail range includes 12-millimetre diameters and 300-millimetre lengths.
Who Else Makes It
Concentrated in Jiangsu (7), Shanghai (3), Zhejiang (3). 10 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| 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 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Turnxon Precision Co., Ltd. | Dongguan | Guangdong | 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 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
Showing 12 of 17. All 17 manufacturers in China registered for Rod, Fixation, Intramedullary And Accessories
Record
| Listed by | I.T.S. Gmbh, Austria |
|---|---|
| FDA product code | HSB |
| Device type | Rod, Fixation, Intramedullary And Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3020 |
| Establishment | Complaint-file establishment, Manufacturer |
| 510(k) | K132945 |
| Record published | 2016-09-14 |
| Record revised | 2025-09-04 (version 3) |
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 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 12112-300 | In distribution | |
| 12112-440 | In distribution | |
| 12110-360 | In distribution | |
| 12112-420 | In distribution | |
| 12110-320 | In distribution | |
| 12112-380 | In distribution | |
| 12110-460 | In distribution | |
| 12112-400 | In distribution | |
| 12112-320 | In distribution | |
| 12110-380 | In distribution | |
| 12112-460 | In distribution | |
| 12110-300 | In distribution | |
| 12110-440 | In distribution | |
| 12110-340 | In distribution | |
| 12110-420 | In distribution | |
| 12112-360 | In distribution | |
| 12112-340 | In distribution | |
| 12110-400 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| T2 | Stryker GmbH | 1,373 |
| Autobahn | Globus Medical, Inc. | 1,258 |
| Gamma | Stryker GmbH | 1,120 |
| Summa Orthopaedics Femur Nail System | Jeil Medical Corporation | 742 |
| Arix Femur Nail System | Jeil Medical Corporation | 742 |
| Orthofix | Orthofix SRL | 721 |
| Rod, Fixation, Intramedullary And Accessories | Synthes Gmbh | 715 |
| Trigen | Smith & Nephew, Inc. | 681 |
| Arthrex® | Arthrex, Inc. | 665 |
| Precice® Intramedullary Limb Lengthening System | NuVasive Specialized Orthopedics, Inc. | 596 |
| Apex | Orthoxel Designated Activity Company | 569 |
| Natural Nail® | Zimmer, Inc. | 552 |
Showing 12 of 2,207. All products under Rod, Fixation, Intramedullary And Accessories
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K233134 | 2024-02-12 |
| K132945 | 2014-03-07 |
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.