AMFEX Limb Reconstruction Pediatric Fixator is a Pediatric Orthopedic External Fixation system designed, according to the provided product data, for Limb Reconstruction applications requiring an External Fixation Construct specifically intended for pediatric orthopedic use.
The system incorporates a Multi-Section External Fixator Body with multiple Connection / Fixation Interfaces and integrated mechanical sections distributed along the device body. It functions as an external fixation structure that can be integrated with compatible Bone Fixation Elements and other system components according to anatomy, fixation site, Bone Segment Configuration, and the surgical plan.
The Fixator design includes multiple Structural Sections along the longitudinal axis of the device, with several connection points that provide options during Fixation Element Positioning and Reconstruction Construct Planning, in accordance with the applicable Surgical Technique.
According to the provided table, the product family is listed under:
Cat. No.: AMS 604.012
and is available in three configurations:
Short – Medium – Long
Each variant carries an individual Cat. No. and GTIN Number, supporting accurate Device Identification, Product Traceability, Surgical Set Preparation, Procurement, Inventory Management, and Stock Control.
Product Description
The Pediatric Limb Reconstruction Fixator is an External Skeletal Fixation Device intended for use in Pediatric Orthopedic applications. It is positioned externally and connected to the bone through compatible Bone Fixation Elements according to the fixation system design.
The general Construct can be represented as follows:
Bone Segment → Fixation Elements → Fixator Interface → AMFEX Limb Reconstruction Pediatric Fixator
The device functions as a Structural External Frame that supports stabilization and arrangement of Bone Segments according to the surgical plan and Approved Indications.
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 Structural Sections
The device features a multi-section configuration extending along its longitudinal body, providing more than one region for connection and component arrangement within the Reconstruction Construct.
- Fixation / Connection Interfaces
Multiple Connection Points are incorporated into the Fixator Body for connection with compatible Bone Fixation Elements or Connecting Components.
- Mechanical Adjustment Sections
The design includes integrated Mechanical Sections that may be associated with adjustment of the Construct according to the fixation system design.
However, the provided data do not officially specify:
- Adjustment Range
- Translation Range
- Compression Range
- Distraction Range
- Angular Correction Range
Therefore, values for these parameters should not be assumed or published without reference to the official Technical Datasheet or IFU.
- Bone Fixation Zones
The terminal and intermediate sections of the Fixator provide different interfaces for arranging compatible Bone Fixation Elements within the Construct.
- Configuration Options
The system is available in:
- Short
- Medium
- Long
providing multiple options during Device Selection according to the requirements of the clinical case.
Product Use
AMFEX Limb Reconstruction Pediatric Fixator is intended for Pediatric Orthopedic External Fixation applications related to limb reconstruction, according to the Approved Indications of the fixation system.
When officially included within the IFU, applications may include:
- Pediatric Limb Reconstruction
- External Skeletal Fixation
- Bone Segment Stabilization
- Complex Pediatric External Fixation Constructs
- Fracture Stabilization
- Orthopedic Reconstruction Procedures
- Bone Segment Management according to the approved technique
Selection of the appropriate configuration depends on:
- Pediatric Anatomy
- Bone Dimensions
- Anatomical Region
- Bone Segment Geometry
- Fixation Site
- Required Construct Length
- Fixation Element Position
- Soft-Tissue Considerations
- Preoperative Planning
- Intraoperative Assessment
The system should be selected, applied, and adjusted by a Qualified Orthopedic Surgeon in accordance with the official IFU and Surgical Technique.
Key Benefits
Pediatric Limb Reconstruction Application
Designed as an External Fixation System intended for Limb Reconstruction in Pediatric Orthopedics, according to the product designation.
Three Configuration Options
The product is available in:
Short | Medium | Long
providing multiple Device Configurations during surgical planning.
Multi-Section Fixator Design
Provides a multi-section configuration within a single Fixator Body, incorporating multiple Connection Interfaces.
Multiple Fixation Points
Multiple connection points support the arrangement of compatible Bone Fixation Elements according to the required Reconstruction Construct.
Reconstruction Planning Flexibility
The available configurations support:
- Preoperative Device Selection
- Fixation Element Positioning
- Construct Planning
- Intraoperative Assembly
Product Traceability
Each configuration 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 604.012.001 | 6221361013339 |
| Medium | AMS 604.012.002 | 6221361013346 |
| Long | AMS 604.012.003 | 6221361013353 |
Technical Overview
Product Name: AMFEX Limb Reconstruction Pediatric Fixator
Product Type: Pediatric Limb Reconstruction External Fixator
Product Category: Pediatric Orthopedic External Fixation System
Patient Category: Pediatric
General Cat. No.: AMS 604.012
Available Configurations: Short / Medium / Long
Number of Configurations: 3
Design Concept: Multi-Section External Reconstruction Fixator
Functional Role: External Skeletal Fixation & Pediatric Limb Reconstruction according to approved indications
Identification: Individual Cat. No. & GTIN No. for each configuration
Product Features
- AMFEX Pediatric Limb Reconstruction Fixator Design.
- Intended for Pediatric Orthopedic Reconstruction applications according to the provided product data.
- Features a Multi-Section External Fixator Body.
- Incorporates Multiple Fixation / Connection Points.
- Includes visible 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.
- Supports positioning of compatible Bone Fixation Elements.
- Designed for use within compatible Pediatric External Fixation Systems.
- General Cat. No.: AMS 604.012.
- Individual GTIN Number for each configuration.
- Supports Product Identification, Traceability, Procurement, and Inventory Management.
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