Cannulated Tibia Nail
Cannulated Tibia Nail from I.T.S. is an intramedullary implant placed antegrade over a calibrated guidewire. The nail has proximal and distal bends to follow tibial anatomy and uses…
Cannulated Tibia Nail from I.T.S. is an intramedullary implant placed antegrade over a calibrated guidewire. The nail has proximal and distal bends to follow tibial anatomy and uses cross-screws for fixation.
Available diameters are 9, 10, 11 and 12 mm, with lengths from 240 to 420 mm in 15 mm increments. A proximal dynamization slot and optional end caps support the fixation configuration.
Listed Item
Cannulated Tibia Nail, D=9.0mm, L=390mm
Materials and Instruments
The nail, end caps and screws use titanium alloy with an anodized DOTIZE surface treatment and are supplied nonsterile. The system includes insertion guides, drill sleeves, drills, screwdriver, depth gauge and removal instruments. Distal screw-hole localization uses fluoroscopy.
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 |
|---|---|---|
| 11209-390 | In distribution | |
| 11211-375 | In distribution | |
| 11209-315 | In distribution | |
| 11210-345 | In distribution | |
| 11209-345 | In distribution | |
| 11209-405 | In distribution | |
| 11211-285 | In distribution | |
| 11209-300 | In distribution | |
| 11209-285 | In distribution | |
| 11211-315 | In distribution | |
| 11210-375 | In distribution | |
| 11211-390 | In distribution | |
| 11211-300 | In distribution | |
| 11210-420 | In distribution | |
| 11209-375 | In distribution | |
| 11211-345 | In distribution | |
| 11209-360 | In distribution | |
| 11211-360 | In distribution | |
| 11211-405 | In distribution | |
| 11210-330 | In distribution | |
| 11210-315 | In distribution | |
| 11209-420 | In distribution | |
| 11210-405 | In distribution | |
| 11211-420 | In distribution | |
| 11210-390 | In distribution | |
| 11210-285 | In distribution | |
| 11210-360 | In distribution | |
| 11209-330 | In distribution | |
| 11211-330 | In distribution | |
| 11210-300 | 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.