AMFEX Limb Reconstruction Fixator for Femur & Tibia in Adult is an Orthopedic External Fixation system designed, according to the provided product data, for Limb Reconstruction applications involving the Femur and Tibia in adult patients.
The system incorporates an elongated External Fixator Body with multiple Connection / Fixation Interfaces and integrated mechanical sections within the device body. It functions as a Structural External Fixation Construct that can be integrated with compatible Bone Fixation Elements according to the clinical requirements and surgical plan.
The design includes multiple Structural Sections along the length of the device, with Connection Points distributed across the Fixator Body. This configuration allows construction of a Reconstruction Frame Configuration according to bone location, Bone Segment Positioning, and the fixation elements being used, in accordance with the applicable Surgical Technique.
According to the provided table, the product family is listed under:
Cat. No.: AMS 604.011
and is available in three configurations:
Short – Medium – Long
Each variant carries an individual Cat. No. and GTIN Number, supporting Device Identification, Surgical Set Preparation, Product Traceability, 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 to create a Mechanical Construct used within limb reconstruction procedures according to the approved indications.
The general system concept can be represented as follows:
Femur / Tibia → Bone Fixation Elements → Fixator Interfaces → AMFEX Limb Reconstruction Fixator
The device functions as an external structural frame supporting the arrangement and stabilization of Bone Segments according to the surgical reconstruction plan.
Product Components and Design
- Central Reconstruction Fixator Body
The main body of the device, functioning as the Structural Core of the External Fixation System.
- Multiple Fixation Interfaces
Multiple Connection Points are visible along the sides and body of the device, intended for use with compatible Bone Fixation Elements or Connecting Components.
- Mechanical Adjustment Sections
The design incorporates multiple Mechanical Sections integrated within the longitudinal Fixator Body.
However, the provided data do not officially specify:
- Adjustment Range
- Translation Range
- Compression / Distraction Range
- Angular Correction Range
Therefore, values for these characteristics should not be stated without reference to the official Technical Datasheet.
- Bone Fixation Connection Zones
The terminal and intermediate sections provide different interfaces for arranging fixation elements according to the Reconstruction Construct design.
- Configuration Options
The device is available in:
- Short
- Medium
- Long
providing more than one Device Configuration when selecting the appropriate system for the clinical case.
Product Use
AMFEX Limb Reconstruction Fixator for Femur & Tibia is used within Orthopedic External Fixation applications involving limb reconstruction and may include, only according to the Approved Indications:
- Femoral Limb Reconstruction
- Tibial Limb Reconstruction
- External Fracture Stabilization
- Bone Segment Stabilization
- Complex External Fixation Constructs
- Orthopedic Reconstruction Procedures
- Selected Bone Transport or Segment Management applications if officially included within the IFU
Selection of the appropriate configuration depends on:
- Adult Femoral / Tibial Anatomy
- Bone Segment Geometry
- Fixation Site
- Required Construct Length
- Bone Fixation Element Position
- Reconstruction Plan
- Soft-Tissue Considerations
- Preoperative Planning
- Intraoperative Assessment
The system should be selected, applied, and adjusted by a Qualified Orthopedic Surgeon in accordance with the approved IFU and Surgical Technique.
Key Benefits
Limb Reconstruction Application
Designed, according to the product designation, for Limb Reconstruction applications involving the Femur and Tibia.
Femur & Tibia Compatibility
Provides a product family intended for:
Femur & Tibia – Adult
Three Configuration Options
The product is available in:
Short | Medium | Long
providing different options during Device Selection.
Multi-Section External Fixator Design
The design incorporates multiple Structural Sections and Connection Points within a single Fixator Body.
Reconstruction Construct Flexibility
The system provides an external platform on which compatible Bone Fixation Elements can be arranged according to the surgical plan and System Compatibility.
Individual Product Coding
Each configuration has an individual Cat. No. to facilitate:
- Device Identification
- Surgical Set Preparation
- Procurement
- Inventory Management
GTIN Traceability
Each variant carries an individual GTIN Number to support:
- Product Traceability
- Inventory Tracking
- Stock Control
- Supply Chain Management
Technical Specifications
| Size / Configuration | Cat. No. | GTIN No. |
| Short | AMS 604.011.001 | 6221361013308 |
| Medium | AMS 604.011.002 | 6221361013315 |
| Long | AMS 604.011.003 | 6221361013322 |
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 604.011
Available Configurations: Short / Medium / Long
Number of Configurations: 3
Design Concept: Multi-Section External Reconstruction Fixator
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 according to the provided product data.
- Features a Multi-Section External Structural Fixator Body.
- Incorporates Multiple Connection / Fixation Points.
- Includes Mechanical Adjustment Sections within the design.
- Available in 3 Configurations.
- Available options: Short, Medium, 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.
- General Cat. No.: AMS 604.011.
- Individual GTIN Number for each configuration.
- Supports Product Identification and Traceability.
- Facilitates Procurement, Inventory Management, and Stock Control.
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