AMFEX Dynamic Axial Movable Head External Fixator for Femur & Tibia in Adult is an Orthopedic External Fixation System intended, according to the provided product designation, for adult Femur and Tibia fixation applications.
The system incorporates a Dynamic Axial External Fixation Concept together with a Movable Head Configuration, allowing construction of an External Fixation Construct according to bone location, orientation of fixation elements, and the surgical plan, in accordance with the applicable Surgical Technique and IFU.
The illustrated design incorporates a Central Fixator Body with Connecting / Movable Head Sections at the ends and Mechanical Adjustment features within the assembly. It functions as a central fixation unit connecting compatible Bone Fixation Elements and supporting construction of the Final External Fixation Frame.
According to the provided product table, the device is available in three sizes:
Small – Medium – Large
The product family is listed under the general reference:
Cat. No.: AMS 604.003
Each size also carries an individual GTIN Number, supporting Product Identification, Traceability, Surgical Set Preparation, Procurement, Inventory Management, and Stock Control.
Product Description
A Dynamic Axial External Fixator is an External Skeletal Fixation Device used externally to connect and stabilize Bone Segments through compatible Pins / Schanz Screws or other approved bone fixation elements.
Its general construct can be represented as follows:
Bone → Schanz Pin / Fixation Element → Movable Head / Clamp → AMFEX Fixator Body → Opposite Fixation Element
The term Dynamic Axial refers to the system’s design as an Axial Fixator incorporating dynamic movement / adjustment characteristics according to the approved device mechanism. However, the actual range of motion and degree of Dynamization are not specified in the provided data.
Product Components and Design
- Central Fixator Body
The central body of the device, functioning as the primary structural component within the External Fixation Construct.
- Movable Head Components
The system incorporates Head / Clamp Sections at its ends that form part of the interface with compatible fixation elements.
- Axial Adjustment Mechanism
The device shows a Mechanical Adjustment Section along its longitudinal axis, consistent with the Dynamic Axial product designation.
The provided table does not specify:
- Adjustment Range
- Compression Range
- Distraction Range
- Degree or limits of Dynamization
Therefore, these parameters should not be stated without reference to the official Technical Datasheet or Surgical Technique.
- Pin / Rod Connection Interface
The ends of the system incorporate interfaces intended to receive compatible Bone Fixation Components.
- Size Configurations
The product is available in:
- Small
- Medium
- Large
providing multiple options for selecting a suitable configuration according to the clinical case and anatomy.
Product Use
AMFEX Dynamic Axial Movable Head External Fixator is intended for compatible Orthopedic External Fixation applications involving:
- Femoral External Fixation
- Tibial External Fixation
- Fracture Stabilization
- Bone Segment Stabilization
- Temporary or Definitive External Fixation when included within the approved indications
- Orthopedic Reconstruction Procedures compatible with the fixation system
Selection of the appropriate size and Construct depends on factors including:
- Adult Femoral / Tibial Anatomy
- Fracture Location
- Bone Segment Position
- Pin / Schanz Screw Placement
- Required Frame Geometry
- Fixator Size
- Preoperative Planning
- Intraoperative Assessment
The system should be selected and used by a Qualified Orthopedic Surgeon in accordance with the official IFU and Surgical Technique.
Key Benefits
Femur & Tibia Application
Designed, according to the provided product information, for External Fixation applications involving the Femur and Tibia in adult patients.
Dynamic Axial Design
Provides an Axial Fixator Configuration as part of the surgical fixation system design.
Movable Head Geometry
The Movable Head Design provides additional options for arranging Fixator components according to the required Construct.
Three Size Options
Available in:
Small / Medium / Large
providing multiple options during Device Selection.
Integrated External Fixator Body
Provides a central fixation unit for connecting compatible Bone Fixation Components within a single Construct.
Product Traceability
An individual GTIN Number for each size supports:
- Product Identification
- Product Traceability
- Procurement
- Inventory Management
- Stock Control
Technical Specifications
| Size | Cat. No. as Listed in the Table | GTIN No. |
| Small | AMS 604.003.003 | 6221361017009 |
| Medium | AMS 604.003.003 | 6221361017016 |
| Large | AMS 604.003.003 | 6221361017023 |
Data Note: The provided table lists the same Cat. No. AMS 604.003.003 for Small, Medium, and Large sizes, while each size has a different GTIN Number. The Cat. No. assignment should therefore be verified against the official catalog or Technical Datasheet before publication if separate size-specific catalog numbers are expected.
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
Anatomical Application: Femur & Tibia
Patient Category: Adult
Design: Dynamic Axial with Movable Head
General Cat. No.: AMS 604.003
Available Sizes: Small / Medium / Large
Number of Configurations: 3
Functional Role: External Skeletal Stabilization according to approved indications
Identification: Individual GTIN No. for each listed size
Product Features
- Dynamic Axial External Fixator Design.
- Intended for Adult Femur & Tibia External Fixation applications according to approved indications.
- Incorporates a Movable Head Configuration.
- Features an integrated Central Fixator Body.
- Includes visible Mechanical Adjustment Features within the design.
- Available in 3 Sizes.
- Available options: Small, Medium, and Large.
- Supports Preoperative Fixator Selection.
- Provides flexibility during Intraoperative Construct Assembly.
- Designed for integration with compatible Bone Fixation Elements.
- General Cat. No.: AMS 604.003.
- Individual GTIN Number for each size.
- Supports Product Identification and Traceability.
- Facilitates Procurement, Inventory Management, and Stock Control.
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