AMFEX External Fixator for Pelvis is an Orthopedic External Fixation system designed for external fixation applications involving the Pelvis, according to the approved indications and Surgical Technique of the system.
The device incorporates a Central External Fixator Body extending between two terminal sections designed for connection with compatible bone fixation elements. This allows construction of a Pelvic External Fixation Construct according to fixation sites, Pelvic Anatomy, Pin Placement, and the surgical plan.
The illustrated design incorporates a central external fixation unit with Bilateral End Components / Fixation Heads on both sides of the device, together with integrated Mechanical Features within the main body. These elements function as a single assembly to connect compatible Bone Fixation Elements and maintain the Construct according to the fixation system instructions.
According to the provided data, the product is available in:
Universal Configuration
The product table lists:
AMS 604.014.001
with:
GTIN 6221361013360
supporting Device Identification, Product Traceability, Surgical Set Preparation, Procurement, Inventory Management, and Stock Control.
Product Description
A Pelvic External Fixator is an External Skeletal Fixation Device positioned outside the body and connected to bone through compatible Bone Fixation Elements according to the fixation system design.
The general Construct can be represented as follows:
Pelvic Bone → Fixation Pins / Screws → Fixator Head → AMFEX External Fixator Body → Opposite Fixation Head
The device functions as an external structural frame connecting fixation elements positioned on both sides of the Pelvic Construct according to the surgical plan.
Product Components and Design
- Central Fixator Body
The main body of the device, functioning as the Structural Core of the External Fixation System.
- Bilateral Fixation Heads
A Head / Connection Component is positioned at each end of the device for connection with compatible Bone Fixation Elements.
- Fixation Interfaces
The terminal sections incorporate connection points designed for integration with compatible Pins or Connecting Components according to the fixation system design.
- Mechanical Adjustment Features
The device shows multiple Mechanical Features along the Central Body that may be associated with adjustment or locking within the Construct.
However, the provided data do not specify:
- Adjustment Range
- Compression / Distraction Range
- Angular Range
- Locking Mechanism
Therefore, these specifications should not be stated without reference to the official Technical Datasheet or IFU.
- Universal Configuration
The product is available in a single configuration listed as:
Universal
therefore eliminating the need to select between Short / Medium / Long configurations for this product.
Product Use
AMFEX External Fixator for Pelvis is intended for compatible Pelvic External Fixation applications and may be used, according to the Approved Indications, in:
- Pelvic External Fixation
- External Pelvic Stabilization
- Temporary Pelvic Stabilization
- Pelvic Bone Segment Stabilization
- Orthopedic Trauma Procedures involving the pelvic region
- Reconstruction / Stabilization Procedures when approved within the IFU
The Final Construct depends on factors including:
- Pelvic Anatomy
- Fixation Site
- Bone Quality
- Pin / Screw Placement
- Soft-Tissue Considerations
- Required Frame Geometry
- Preoperative Planning
- Intraoperative Assessment
The system should be selected and applied by a Qualified Orthopedic Surgeon in accordance with the official IFU and Surgical Technique.
Key Benefits
Pelvic External Fixation Application
Designed, according to the product designation, for:
Pelvic External Fixation
Universal Configuration
The device is available in:
Universal
providing a single configuration within this Product Family.
Bilateral Fixation Structure
The device incorporates Connection / Fixation Heads on both sides to form a Pelvic External Fixator Construct.
Integrated Central Body
The design combines a Central Fixator Body and Fixation Interfaces within a single External Fixation Assembly.
Simplified Product Selection
The Universal Configuration simplifies:
- Device Identification
- Surgical Set Preparation
- Inventory Planning
- Procurement
Product Traceability
The product carries an individual Cat. No. and GTIN Number to support:
- Product Identification
- Product Traceability
- Inventory Management
- Stock Control
- Supply Chain Management
Technical Specifications
| Size / Configuration | Cat. No. | GTIN No. |
| Universal | AMS 604.014.001 | 6221361013360 |
Technical Overview
Product Name: AMFEX External Fixator for Pelvis
Product Type: Pelvic External Fixator
Product Category: Orthopedic External Fixation System
Anatomical Application: Pelvis
Available Configuration: Universal
Number of Configurations: 1
Visible Product Code: AMS 604.014.001
Functional Role: External Pelvic Stabilization according to approved indications
Design Concept: Central External Fixator Body with Bilateral Fixation Interfaces
Identification: Individual Cat. No. & GTIN No.
Product Features
- AMFEX Pelvic External Fixator Design.
- Intended for Pelvic Orthopedic External Fixation applications.
- Incorporates a Central Structural Fixator Body.
- Features Bilateral Fixation / Connection Interfaces.
- Available in a Universal Configuration.
- Integrated design within a single External Fixation Assembly.
- Supports Preoperative Device Planning.
- Designed for integration with compatible Bone Fixation Elements.
- Supports Intraoperative Construct Assembly.
- Dedicated Product Code for the Universal Configuration.
- Individual GTIN Number.
- Supports Product Identification and Traceability.
- Facilitates Procurement, Inventory Management, and Stock Control.
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