AMFEX Limb Reconstruction Fixator for Femur & Tibia in Adult is an Orthopedic External Fixation system designed for Limb Reconstruction applications involving the Femur and Tibia in adult patients, according to the approved indications and Surgical Technique of the system.
The product incorporates an External Fixator Assembly consisting of a Central Structural Body, terminal Fixation / Connection Components, and an integrated mechanical mechanism. This configuration allows construction of a Reconstruction Construct according to Bone Anatomy, Fixation Site, Bone Segment Position, Pin Placement, and the surgical plan.
One end of the device appears to incorporate an Angled / Articulated Connection Geometry, while the opposite end includes an additional Fixation Interface. These components function together with the Central Body as an integrated system for connecting compatible Bone Fixation Elements within the External Fixator Construct.
According to the provided product data, the family is listed under:
Cat. No.: AMS 604.013
and is available in two configurations:
Short – Long
Each configuration carries an individual Cat. No. and GTIN Number, supporting Device Identification, Product Traceability, Surgical Set Preparation, Procurement, Inventory Management, and Stock Control.
Product Description
A Limb Reconstruction External Fixator is an External Skeletal Fixation Device positioned outside the body and connected to the bone through compatible Bone Fixation Elements. It is intended to create a Mechanical Construct that supports stabilization and management of Bone Segments during approved Limb Reconstruction procedures.
The general Construct can be represented as follows:
Femur / Tibia → Bone Fixation Elements → Fixator Connection Interface → AMFEX Limb Reconstruction Fixator
The device configuration and placement of fixation elements are determined according to the clinical case and surgical plan.
Product Components and Design
- Central Fixator Body
The main central body of the device, functioning as the Structural Core of the External Fixation System.
- Angled / Articulated Head Section
One end of the device appears to feature a Connection Head positioned at an angle relative to the Fixator axis.
However, the provided catalog data do not specify:
- Head Angle
- Angular Adjustment Range
- Locking Positions
- Range of Motion
Therefore, specific values or movement-related claims should not be published without reference to the official Technical Datasheet.
- Opposite Fixation Interface
The opposite end incorporates a Connection Component designed for integration with compatible Bone Fixation Elements or other fixation-system components.
- Mechanical Adjustment Assembly
An integrated Mechanical Mechanism is visible within the Central Fixator Body.
The currently provided data do not specify whether this mechanism provides:
- Compression
- Distraction
- Translation
- Any defined Adjustment Range
These characteristics should therefore not be assumed without official technical documentation.
- Bone Fixation Interfaces
The terminal sections provide connection points for compatible Bone Fixation Elements according to the fixation system design.
- Configuration Options
The system is available in:
- Short
- Long
according to the provided table.
Product Use
AMFEX Limb Reconstruction Fixator for Femur & Tibia in Adult is intended for Orthopedic External Fixation applications involving the Femur and Tibia and may include, according to the Approved Indications:
- Femoral Limb Reconstruction
- Tibial Limb Reconstruction
- External Fracture Stabilization
- Bone Segment Stabilization
- Complex External Fixation Constructs
- Orthopedic Reconstruction Procedures
- Bone Segment Management when officially included within the IFU
Selection of the appropriate Short or Long Configuration depends on:
- Adult Femoral / Tibial Anatomy
- Fixation Site
- Bone Segment Geometry
- Required Construct Length
- Position of Bone Fixation Elements
- Frame Geometry
- Soft-Tissue Considerations
- Preoperative Planning
- Intraoperative Assessment
The device should be selected, applied, and adjusted by a Qualified Orthopedic Surgeon in accordance with the official IFU and Surgical Technique.
Key Benefits
Limb Reconstruction Application
Designed, according to the provided product data, for:
Femur & Tibia Limb Reconstruction in Adult
Two Configuration Options
The system is available in:
Short | Long
providing two options during Device Selection.
Integrated External Fixator Structure
The design combines:
- Central Fixator Body
- Angled / Articulated End Component
- Opposite Fixation Interface
- Mechanical Adjustment Features
within a single External Fixation Assembly.
Multiple Fixation Interfaces
Provides multiple Connection Points for integration with compatible Bone Fixation Elements.
Reconstruction Planning Flexibility
Supports selection of an appropriate configuration during:
- Preoperative Planning
- Component Positioning
- Construct Configuration
- Intraoperative Assembly
Product Traceability
Each variant carries an individual Cat. No. and GTIN Number to support:
- Product Identification
- Product Traceability
- Procurement
- Inventory Management
- Stock Control
Technical Specifications
| Size / Configuration | Cat. No. | GTIN No. |
| Short | AMS 604.013.001 | 6221361043510 |
| Long | AMS 604.013.002 | 6221361045453 |
Technical Overview
Product Name: AMFEX Limb Reconstruction Fixator for Femur & Tibia in Adult
Product Type: Limb Reconstruction External Fixator
Product Category: Orthopedic External Fixation System
Patient Category: Adult
Anatomical Application: Femur & Tibia
General Cat. No.: AMS 604.013
Available Configurations: Short / Long
Number of Configurations: 2
Design Concept: External Reconstruction Fixator with Angled End Connection
Functional Role: External Skeletal Fixation & Limb Reconstruction according to approved indications
Identification: Individual Cat. No. & GTIN No. for each configuration
Product Features
- AMFEX Limb Reconstruction External Fixator Design.
- Intended for Adult Femur & Tibia Reconstruction applications.
- Incorporates a Central Structural Fixator Body.
- Features an Angled / Articulated End Geometry visible in the design.
- Incorporates Multiple Fixation / Connection Interfaces.
- Available in 2 Configurations: Short and Long.
- Individual Product Code for each variant.
- Supports Preoperative Device Selection.
- Provides multiple options during Reconstruction Construct Planning.
- Designed for integration with compatible Bone Fixation Elements.
- Supports Intraoperative Frame Assembly.
- General Cat. No.: AMS 604.013.
- Individual GTIN Number for each configuration.
- Supports Product Identification and Traceability.
- Facilitates Procurement, Inventory Management, and Stock Control.
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