AMFEX Dynamic Axial Movable Head External Fixator for Humerus in Pediatric is an Orthopedic External Fixation system designed, according to the provided product data, for external fixation applications involving the Humerus in compatible Pediatric Orthopedic cases within the approved indications of the system.
The device incorporates a Dynamic Axial External Fixator Configuration with a Movable Head Design. It includes a Central Fixator Body and terminal components for connection with compatible Bone Fixation Elements, allowing construction of an External Fixation Construct according to Humeral Anatomy, Fracture Location, Pin Positioning, and the surgical plan.
The system features an axial design incorporating a Central Structural Body, Movable Head / Clamp Sections, and Mechanical Adjustment Features, which function together within the Fixator Assembly according to the applicable Surgical Technique and IFU.
According to the provided table, the product family is listed under:
Cat. No.: AMS 604.005
and is available in three sizes:
Small – Medium – Large
Each size carries an individual Product Code and GTIN Number, facilitating Device Identification, Surgical Set Preparation, Product Traceability, Procurement, Inventory Management, and Stock Control.
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 according to the fixation system design.
For Humerus applications, the general construct can be represented as follows:
Humerus → Schanz Pin / Fixation Element → Movable Head / Clamp → AMFEX Fixator Body → Opposite Fixation Element
The term Dynamic Axial refers to an Axial Fixator Configuration incorporating an axial movement or adjustment mechanism according to the device design, while Movable Head refers to Head / Clamp Components that allow adjustment or positioning within the limits defined by the fixation system.
The precise Adjustment Range or Dynamization parameters 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 Core of the External Fixation System.
- Movable Head Components
The ends of the system incorporate Movable Head / Clamp Sections designed for connection with compatible fixation elements.
- Axial Adjustment Mechanism
The design incorporates Mechanical Adjustment Features along the longitudinal axis, consistent with the device classification as a Dynamic Axial Fixator.
The range of motion or exact amount of adjustment is not specified in the provided table.
- Bone Fixation Interface
The terminal sections provide interfaces for connection with compatible Schanz Pins or other Fixation Elements according to the fixation system design.
- Size-Specific Configurations
The device is available in three sizes:
- Small
- Medium
- Large
Each size has an individual Product Code and GTIN Number.
Product Use
According to the product designation, AMFEX Dynamic Axial Movable Head External Fixator is intended for compatible Pediatric Humerus External Fixation applications.
Depending on the officially approved indications of the system, it may be incorporated into:
- Pediatric Humeral External Fixation
- External Fracture Stabilization
- Bone Segment Stabilization
- Temporary External Fixation when included within the approved indications
- Definitive External Fixation when approved for the system
- Compatible Pediatric Orthopedic Reconstruction Procedures
Selection of the appropriate size and Fixator Construct depends on:
- Pediatric Humeral Anatomy
- Bone Dimensions
- Fracture Location
- Bone Segment Position
- Pin / Schanz Screw Placement
- Required Fixator Geometry
- Soft-Tissue Considerations
- Preoperative Planning
- Intraoperative Assessment
The system should be selected and applied by a Qualified Orthopedic Surgeon in accordance with the approved IFU and Surgical Technique.
Key Benefits
Pediatric Humerus Application
Designed, according to the provided product information, for Pediatric Humerus External Fixation applications.
Dynamic Axial Configuration
Provides an Axial External Fixator Configuration within the surgical fixation system.
Movable Head Design
The Movable Heads provide additional options during positioning and arrangement of Bone Fixation Elements within the Construct.
Three Size Options
The product is available in:
Small | Medium | Large
providing multiple Device Configurations.
Integrated External Fixator Body
The system combines a Central Fixator Body with Movable Head Interfaces within a single assembly.
Individual Product Coding
Each size has an individual Cat. No., supporting:
- 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 604.005.001 | 6221361017061 |
| Medium | AMS 604.005.002 | 6221361017078 |
| Large | AMS 604.005.003 | 6221361013124 |
Technical Overview
Product Name: AMFEX Dynamic Axial Movable Head External Fixator for Humerus in Pediatric
Product Type: Pediatric Dynamic Axial External Fixator
Product Category: Orthopedic External Fixation System
Patient Category: Pediatric
Anatomical Application: Humerus
Design: Dynamic Axial with Movable Head
General Cat. No.: AMS 604.005
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
- Pediatric Dynamic Axial External Fixator Design.
- Intended for Humerus External Fixation applications according to the provided product data.
- 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 604.005.
- Individual GTIN Number for each configuration.
- Supports Product Identification and Traceability.
- Facilitates Procurement, Inventory Management, and Stock Control.
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