Talon™ DistalFix™ Lag Screw
The Talon DistalFix lag screw is an implant component of the proximal femoral nail system used to stabilize fractures while bone union occurs. It passes through the nail into the femoral…
The Talon DistalFix lag screw is an implant component of the proximal femoral nail system used to stabilize fractures while bone union occurs. It passes through the nail into the femoral neck and head as part of the fixation construct.
The cannulated titanium alloy screw contains deployable talons that extend through its portals to increase purchase in bone. Its keyed shaft has tapered flats and allows static, compression or axial translation fixation within the nail system.
Listed Item
Talon™ DistalFix™ Lag Screw 11mm x 105mm
Assembly and Removal
The screw is supplied preassembled with its deployable talons and end cap. The talons can be retracted if screw removal becomes necessary. The keyed design also limits rotation and proximal migration of the lag screw within the construct.
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) | K111352 |
| Record published | 2015-10-19 |
| Record revised | 2024-02-19 (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 | Outer diameter 11 mm; length 70 to 120 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SLN011070 | Outer Diameter 11 mm | In distribution |
| SLN011105 | Length 105 mm | In distribution |
| SLN011100 | Outer Diameter 11 mm | In distribution |
| SLN011085 | Length 85 mm | In distribution |
| SLN011110 | Outer Diameter 11 mm | In distribution |
| SLN011080 | Outer Diameter 11 mm | In distribution |
| SLN011095 | Length 95 mm | In distribution |
| SLN011075 | Length 75 mm | In distribution |
| SLN011115 | Length 115 mm | In distribution |
| SLN011090 | Outer Diameter 11 mm | In distribution |
| SLN011120 | Outer Diameter 11 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.