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AMFEX Dynamic Axial Movable Head External Fixator for Femur & Tibia in Adult

Adult Dynamic Axial External Fixator | Movable Head Design | Small / Medium / Large | Cat. No. AMS 604.004

AMFEX Dynamic Axial Movable Head External Fixator is an Orthopedic External Fixation System intended for fixation of the Femur and Tibia in adult patients. It combines a Dynamic Axial Configuration with a Movable Head Design and is available in Small, Medium, and Large sizes, providing multiple options according to anatomy and Fixation Construct requirements.

  • Dynamic Axial External Fixator Design intended for Adult Femur & Tibia External Fixation applications according to the approved indications.
  • Movable Head Configuration provides multiple options during positioning and assembly of Fixator components.
  • Available in 3 Sizes: Small / Medium / Large to accommodate different requirements during Device Selection.
  • Each size has an individual Cat. No. and GTIN No. to support Product Identification, Traceability, and Inventory Management.

AMFEX Dynamic Axial Movable Head External Fixator for Femur & Tibia in Adult is an Orthopedic External Fixation system designed, according to the provided product data, for external fixation applications involving the Femur and Tibia in adult patients.

The system incorporates a Dynamic Axial Fixator Configuration with a Movable Head Design, providing a central external fixation unit that can be integrated with compatible Bone Fixation Elements and other system components to create the required External Fixation Construct according to fracture location, Bone Anatomy, Pin Placement, and the surgical plan.

The illustrated system includes a Central Fixator Body with End Head / Clamp Sections and Mechanical Adjustment components distributed along the longitudinal axis of the device. This configuration allows integration with compatible bone fixation elements according to the applicable Surgical Technique and IFU.

According to the provided table, the product family is listed under:

Cat. No.: AMS 604.004

and is available in three sizes:

Small – Medium – Large

Each size has an individual Product Code, providing clear organization for Preoperative Device Selection, Surgical Set Preparation, Procurement, and Inventory Management.

Product Description

A Dynamic Axial External Fixator is an External Skeletal Fixation Device positioned externally and connected to the bone through compatible Bone Fixation Elements such as Schanz Pins / Screws according to the fixation system design.

Its general construct can be represented as follows:

Bone → Fixation Pin / Schanz Screw → Movable Head / Clamp → AMFEX Fixator Body → Opposite Fixation Elements

The term Dynamic Axial describes the system as an Axial External Fixator with a Dynamic Configuration, while Movable Head refers to a Head Geometry designed to allow movement or adjustment according to the device design.

The detailed values for the range of motion or Dynamic Adjustment are not specified in the currently provided data.

Product Components and Design

  1. Central Fixator Body

The main central body of the device, functioning as the Structural Core of the External Fixation System.

  1. Movable Head Sections

The ends of the device incorporate Head / Clamp Components that function as connection interfaces with compatible Bone Fixation Elements or Connecting Components.

  1. Axial Adjustment Assembly

The device features a Mechanical Adjustment Mechanism extending along its longitudinal axis, consistent with its classification as a Dynamic Axial Fixator.

The provided data do not specify the exact Adjustment Range.

  1. Connection / Clamp Interfaces

The terminal sections provide interfaces designed to connect compatible fixation components and construct the Final External Fixator Construct.

  1. Size-Specific Configurations

The device is available in three sizes:

  • Small
  • Medium
  • Large

with an individual Product Code for each configuration.

Product Use

According to the provided product information, AMFEX Dynamic Axial Movable Head External Fixator is intended for External Fixation applications involving:

  • Femoral External Fixation
  • Tibial External Fixation
  • Fracture Stabilization
  • Bone Segment Stabilization
  • Temporary External Fixation when included within the approved indications
  • Definitive External Fixation when approved for the product system
  • Compatible Orthopedic Reconstruction Procedures

Selection of the appropriate size and Construct depends on:

  • Adult Femoral / Tibial Anatomy
  • Fracture Location
  • Bone Segment Geometry
  • Pin / Schanz Screw Position
  • Required Fixator Configuration
  • Soft-Tissue Considerations
  • Preoperative Planning
  • Intraoperative Assessment

The system should be selected and applied by a Qualified Orthopedic Surgeon in accordance with the official IFU and Surgical Technique.

Key Benefits

Femur & Tibia Application

According to the product designation, the system is intended for External Fixation applications involving:

Femur & Tibia – Adult

Dynamic Axial Configuration

Provides an Axial Fixator Design within an External Skeletal Fixation system.

Movable Head Design

The Movable Head Configuration provides additional positioning and arrangement options for Fixator components according to the system design.

Three Size Options

Available in:

Small | Medium | Large

providing multiple configurations during Device Selection.

Integrated Fixator Construct

Provides a Central Fixator Body that can be integrated with compatible Bone Fixation Elements to create an External Fixation Frame.

Clear Product Coding

Each size has an individual Product Code, facilitating:

  • Device Identification
  • Surgical Set Preparation
  • Procurement
  • Inventory Management

GTIN Traceability

Each size has an individual GTIN Number to support:

  • Product Traceability
  • Stock Control
  • Inventory Tracking
  • Supply Chain Management

Technical Specifications

Size Cat. No. GTIN No.
Small AMS 604.004.001 6221361017030
Medium AMS 604.004.002 6221361017047
Large AMS 604.004.003 6221361017054

Technical Overview

Product Name: AMFEX Dynamic Axial Movable Head External Fixator for Femur & Tibia in Adult

Product Type: Dynamic Axial External Fixator

Product Category: Orthopedic External Fixation System

Patient Category: Adult

Anatomical Application: Femur & Tibia

Design: Dynamic Axial with Movable Head

General Cat. No.: AMS 604.004

Available Sizes: Small / Medium / Large

Number of Configurations: 3

Functional Role: External Skeletal Stabilization according to approved indications

Identification: Individual Cat. No. & GTIN No. for each size

Product Features

  • Dynamic Axial External Fixator Design.
  • Intended for Adult Femur & Tibia External Fixation applications.
  • Incorporates a Movable Head Configuration.
  • Features a Central Structural Fixator Body.
  • Includes visible Mechanical Adjustment Features within the design.
  • Available in 3 Size Configurations.
  • Available sizes: Small, Medium, and Large.
  • Individual Product Code for each size.
  • Supports Preoperative Device Selection.
  • Provides multiple options during Intraoperative Construct Assembly.
  • Designed for integration with compatible Bone Fixation Elements.
  • General Cat. No.: AMS 604.004.
  • Individual GTIN Number for each size.
  • Supports Product Identification and Traceability.
  • Facilitates Procurement, Inventory Management, and Stock Control.

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