Talon™ DistalFix™ Humeral Nail
The Talon DistalFix Humeral Nail aligns and stabilizes fractures of the humerus. Its indications include shaft fractures, proximal fractures extending into the shaft and impending…
The Talon DistalFix Humeral Nail aligns and stabilizes fractures of the humerus. Its indications include shaft fractures, proximal fractures extending into the shaft and impending pathological fractures.
The titanium alloy nail has proximal openings for locking screws and distal openings for integral deployable talons. The distal talons secure fixation from inside the medullary canal and can retract for later nail removal when required.
Listed Item
Talon™ DistalFix™ Humeral Nail 4° | Ø10mm | 285mm
Additional Fixation Components
Separate cortical locking screws can provide proximal fixation. A separately supplied proximal end cap protects threads used to attach removal instruments and limits bone ingrowth into that connection. The nail is supplied preassembled with its distal talons and distal end cap.
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 | Orthopedic Designs North America, Inc., United States |
|---|---|
| FDA product code | HSB |
| Device type | Rod, Fixation, Intramedullary And Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3020 |
| Establishment | Manufacturer |
| 510(k) | K173255 |
| Record published | 2018-03-16 |
| Record revised | 2025-02-06 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Sizes | Angle 4 °; length 165 to 315 mm; outer diameter 8 to 10 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| HTN409225 | Angle 4 ° | In distribution |
| HTN409315 | Angle 4 ° | In distribution |
| HTN408195 | Outer Diameter 8 mm | In distribution |
| HTN410285 | Outer Diameter 10 mm | In distribution |
| HTN409285 | Angle 4 ° | In distribution |
| HTN410165 | Outer Diameter 10 mm | In distribution |
| HTN408270 | Angle 4 ° | In distribution |
| HTN409300 | Outer Diameter 9 mm | In distribution |
| HTN410210 | Angle 4 ° | In distribution |
| HTN410315 | Outer Diameter 10 mm | In distribution |
| HTN408225 | Outer Diameter 8 mm | In distribution |
| HTN408180 | Angle 4 ° | In distribution |
| HTN409180 | Outer Diameter 9 mm | In distribution |
| HTN408255 | Outer Diameter 8 mm | In distribution |
| HTN408210 | Angle 4 ° | In distribution |
| HTN409255 | Angle 4 ° | In distribution |
| HTN410255 | Outer Diameter 10 mm | In distribution |
| HTN408240 | Angle 4 ° | In distribution |
| HTN408285 | Outer Diameter 8 mm | In distribution |
| HTN410240 | Angle 4 ° | In distribution |
| HTN408300 | Angle 4 ° | In distribution |
| HTN409240 | Outer Diameter 9 mm | In distribution |
| HTN408165 | Outer Diameter 8 mm | In distribution |
| HTN410270 | Angle 4 ° | In distribution |
| HTN409195 | Angle 4 ° | In distribution |
| HTN410225 | Outer Diameter 10 mm | In distribution |
| HTN410300 | Angle 4 ° | In distribution |
| HTN410180 | Angle 4 ° | In distribution |
| HTN409165 | Angle 4 ° | In distribution |
| HTN410195 | Outer Diameter 10 mm | In distribution |
| HTN409210 | Outer Diameter 9 mm | In distribution |
| HTN408315 | Outer Diameter 8 mm | In distribution |
| HTN409270 | Outer Diameter 9 mm | 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 |
|---|---|
| K173255 | 2018-02-22 |
| K152295 | 2015-11-03 |
| K111352 | 2011-08-22 |
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.