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TF-Tubular Fixator (Ø12mm-Ø10mm) System

TF-Tubular Fixator (Ø12mm-Ø10mm) System
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TF-Tubular Fixator (Ø12mm-Ø10mm) System

Product catalog summary
Device Description: The TF-Tubular Fixator is a modular external fixator system designed for stabilizing extremity bones. It includes components such as rod to rod clamps, rod to pin clamps, multi-pin clamps, half pins, telescopic rods, and CFRP rods. The system's modularity allows customization based on patient anatomy, using components made from surgical stainless steel or titanium alloy.
Indications: The system is indicated for both open and closed fracture fixation, serving as a temporary or permanent stabilization method.
Contraindications: Contraindications include active infections, local inflammation, fever, obesity, pregnancy, mental illness, congenital abnormalities, rapid joint disease, metal allergies, inadequate tissue coverage, and severe osteoporosis, among others.
General Warnings & Precautions: The device should only be used by trained orthopedic surgeons. Patients must be informed of all risks, and a consent form should be signed. Proper selection and placement of the device are crucial for success, and regular patient monitoring is required. The device is not evaluated for MRI safety.
Part List: The document lists various components such as rod to pin clamps, rod to rod clamps, multi-pin clamps, telescopic rods, CFRP rods, semi-circular bars, half pins, and trans-fixation pins, specifying their sizes and single-use status.
Frame Examples: Examples of frame configurations for tibia and ankle are provided, detailing the number and type of components used in each setup.
Overview: The document provides detailed specifications and descriptions of various medical devices, specifically focusing on titanium alloy bars, half pins, and fixators used in orthopedic procedures. It includes information on implant trays, instrument trays, and the symbols used in packaging.
Specifications: The document lists several items with their dimensions and usage details, such as:
  • F-6101L Ø12mm Titanium Alloy Large Semi-Circular Bar for single use.
  • Various ISO 5832/3 Half Pins with different lengths and diameters for single use.
  • Ø12mm and Ø10mm Tubular Fixator Implant Trays with specific components like CFRP rods and trans-fixation pins.
Procedures and Usage: The document outlines the use of different fixators, including:
  • TF-Tubular Fixator
  • TF-Ilizarov Circular Fixator
  • TF-ERS Pediatric Rail Fixator
Each fixator type is associated with specific implant and instrument trays, detailing the components and their quantities.
Instrument Trays: The document describes the contents of instrument trays, including reusable drivers, wrenches, drill bits, and tubes. These are essential for the application and adjustment of the fixators.
Symbols and Standards: A section is dedicated to explaining the symbols used in packaging, such as:
  • Indication of non-sterilized devices.
  • Batch and catalog numbers for identification.
  • Single-use indications and instructions for use.
  • Manufacturer details and expiration dates.
Manufacturer Information: The document concludes with the manufacturer's details, including contact information and the product catalogue reference.
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Catalog excerpts

TF-Tubular Fixator (Ø12mm-Ø10mm) System-1

Ø12 – Ø10 mm TF-TUBULAR FIXATOR Catalogu

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TF-Tubular Fixator (Ø12mm-Ø10mm) System-2

This document is not a surgical technique. This document shows all parts for the TF-Tubular Fixator System

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TF-Tubular Fixator (Ø12mm-Ø10mm) System-3

TF-TUBULAR FIXATOR Device Description TF-Tubular Fixator is a modular external fixator system. Fixator is built by connecting half pins by clamps and carbon fiber rods. Modular structure of TF-Tubular fixator enables surgeon to built different frames for different cases. Surgeon can insert pins wherever they are needed and connect them with clamps which have got snap-in property. TF-Tubular Fixation System consists of; • Rod to rod clamps • Rod to pin clamps • Multi-pin clamps • Half pins • Telescopic rods • CFRP Rods The list of all components and instruments are given on Annex I of this manual....

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TF-Tubular Fixator (Ø12mm-Ø10mm) System-4

TF-TUBULAR FIXATOR Device Description Contraindications Contraindications include, but are not limited to: 1. Active infectious process or significant risk of infection (immunocompromise). 2. Signs of local inflammation. 3. Fever or leukocytosis. 4. Morbid obesity. 5. Pregnancy. 6. Mental illness. 7. Grossly distorted anatomy caused by congenital abnormalities. 8. Any other medical or surgical condition which would preclude the potential benefit of external fixator surgery, 9. Rapid joint disease, bone absorption, osteopenia, osteomalacia and/or osteoporosis. 10. Suspected or documented metal...

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TF-Tubular Fixator (Ø12mm-Ø10mm) System-5

TF-TUBULAR FIXATOR Device Description General Warnings & Precautions Tasarimmed TF-Tubular fixator is only to sale by or on order of exclusive operator and/or surgeon. The device shall only be used by an orthopeadic surgeon, who is trained and experiences on External Fixation Surgery techniques. • Before the surgery all risks shall be explained to the patient by the surgeon. The consent and acceptance declaration shall be signed by the patient. • The surgeon must confirm that all necessary Tasarimmed TF-Tubular Fixation System components and instruments are on hand for the planed surgical operation....

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TF-Tubular Fixator (Ø12mm-Ø10mm) System-6

TF-TUBULAR FIXATOR Part List Rod to Pin Clamp Description Ø12mm Rod to Pin Clamp Ø10mm Rod to Pin Clamp Single Use / Reuseable Single Use Single Use Description Ø12mm Rod to Rod Clamp Ø10mm Rod to Rod Clamp B04-TDTG02 TF Tubular Fixator Ø10mm-Ø12mm Catalogue EN Single Use / Reuseable Single Use

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TF-Tubular Fixator (Ø12mm-Ø10mm) System-7

TF-TUBULAR FIXATOR Part List Multi Pin Clamps Description Ø12mm Rod to Multi-Pin Clamp Ø10mm Rod to Multi-Pin Clamp Ø12mm Straight Multi Pin Clamp Ø10mm Straight Multi Pin Clamp Single Use / Reuseable Single Use Single Use Single Use Single Use Telescopic Rods Description Ø12mm Telescopic Rod Ø10mm Telescopic Rod B04-TDTG02 TF Tubular Fixator Ø10mm-Ø12mm Catalogue EN Single Use / Reuseable Single Us

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TF-Tubular Fixator (Ø12mm-Ø10mm) System-8

TF-TUBULAR FIXATOR Part List CFRP Rods Description Ø12mm CFRP Rod 100mm Ø12mm CFRP Rod 150mm Ø12mm CFRP Rod 200mm Ø12mm CFRP Rod 250mm Ø12mm CFRP Rod 300mm Ø12mm CFRP Rod 350mm Ø12mm CFRP Rod 400mm Ø12mm CFRP Rod 450mm Ø10mm CFRP Rod 70mm Ø10mm CFRP Rod 90mm Ø10mm CFRP Rod 110mm Ø10mm CFRP Rod 150mm Ø10mm CFRP Rod 200mm Ø10mm CFRP Rod 250mm Ø10mm CFRP Rod 300mm B04-TDTG02 TF Tubular Fixator Ø10mm-Ø12mm Catalogue EN Single Use / Reuseable Single Use Single Use Single Use Single Use Single Use Single Use Single Use Single Use Single Use Single Use Single Use Single Use Single Use

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TF-Tubular Fixator (Ø12mm-Ø10mm) System-9

TF-TUBULAR FIXATOR Part List Semi-Circular Bars Description Ø12mm Titanium Alloy Small Semi-Circular Bar Ø12mm Titanium Alloy Medium Semi-Circular Bar Ø12mm Titanium Alloy Large Semi-Circular Bar B04-TDTG02 TF Tubular Fixator Ø10mm-Ø12mm Catalogue EN Single Use / Reuseable Single Use Single Use S

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TF-Tubular Fixator (Ø12mm-Ø10mm) System-10

TF-TUBULAR FIXATOR Part List TF-ILIZAROV CIRCULAR FIXATOR Half Pins Description L = Thread Length , TL = Total Length All Half pins have self cut, self drill tip. ISO 5832/3 Half Pin Ø4 mm – L20mm – TL150mm ISO 5832/3 Half Pin Ø4 mm – L30mm – TL150mm ISO 5832/3 Half Pin Ø4 mm – L40mm – TL180mm ISO 5832/3 Half Pin Ø4 mm – L50mm – TL180mm ISO 5832/3 Half Pin Ø5 mm – L20mm – TL150mm ISO 5832/3 Half Pin Ø5 mm – L30mm – TL150mm ISO 5832/3 Half Pin Ø5 mm – L20mm – TL180mm ISO 5832/3 Half Pin Ø5 mm – L30mm – TL180mm ISO 5832/3 Half Pin Ø5 mm – L40mm – TL180mm ISO 5832/3 Half Pin Ø5 mm – L50mm – TL180mm...

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TF-Tubular Fixator (Ø12mm-Ø10mm) System-11

TF-TUBULAR FIXATOR Part List TF-ILIZAROV CIRCULAR FIXATOR Trans-fixation Pins Description L = Thread Length , TL = Total Length All Half pins have self cut, self drill tip. Surgical Stainless Steel ISO 5832/1 Trans-fixation Pin Ø5 mm – L50mm – TL250mm ISO 5832/1 Trans-fixation Pin Ø5 mm – L70mm – TL300mm ISO 5832/1 Trans-fixation Pin Ø6 mm – L50mm – TL250mm ISO 5832/1 Trans-fixation Pin Ø6 mm – L70mm – TL300mm Single Use Single Use Single Use Single Use TF-ILIZAROV CIRCULAR FIXATOR Cat No Description L = Thread Length , TL = Total Length All Half pins have self cut, self drill tip. Surgical Titanium...

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TF-Tubular Fixator (Ø12mm-Ø10mm) System-12

TF-TUBULAR FIXATOR Instrument List TF-ILIZAROVCat No CIRCULAR FIXATOR Description Single Use / Reusable Reusable Reusable Reusable Reusable Ø6 mm Half Pin Driver Ø5 mm Half Pin Driver Ø4 mm Half Pin Driver 4mm Hex Driver 10mm Open End Wrench 13mm Open End Wrench Reusable Reusable Ø2.7 mm Drill Bit Ø3.2 mm Drill Bit Ø4.2 mm Drill Bit Ø2.7 mm Drill Tube Ø3.2 mm Drill Tube Ø4.2 mm Drill Tube Tissue Protector Single Use Single Use Single Use Reusable Reusable Reusable Reusable TF-ILIZAROV CIRCULAR FIXATOR TF-ILIZAROV CIRCULAR FIXATOR TF-ILIZAROV CIRCULAR FIXATOR TF-ILIZAROV CIRCULAR FIXATOR TF-ILIZAROV...

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