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VCFix® Spinal System

VCFix is Amber’s flagship vertebral reconstruction system, designed to restore vertebral body anatomy and support load-bearing function in defined vertebral fracture patients.

VCFix® is an innovative implant for vertebral body augmentation developed by Amber Implants. We designed this product for the treatment of vertebral compression fractures. The product, consisting of a preparation, implantation, and an optional supplementary fixation kit, is intended to be used to treat and reduce compression fractures in vertebrae that have collapsed due to trauma, tumor, or degenerative diseases.

The VCFix® Spinal System provides internal support and is currently intended for use with cleared bone cement in the U.S., with Amber continuing to evaluate expanded treatment strategies as evidence and indications evolve.

VCFix helps clinicians address the biomechanical needs of vertebral fractures—moving beyond void filling alone toward anatomic restoration, three-column support, and procedural flexibility.

VCFix®: Improving the treatment of spinal fracture

Three-Column Support

VCFix® is designed to support the fractured vertebral body through pedicle-based anchorage, helping distribute biomechanical load across the treated segment.

Efficient Minimally Invasive Workflow

VCFix® includes a streamlined, single-use surgical set designed to support procedural consistency and an efficient minimally invasive workflow.

Load-Bearing Restoration

VCFix® expands in the craniocaudal direction to help address vertebral compression forces and support restoration of vertebral body height and load-bearing function.

Controlled Anatomic Restoration

VCFix® is available in multiple implant sizes and features an adjustable angular expansion mechanism, supporting controlled fracture reduction and patient-specific anatomic restoration.

Inducing Osseointegration

Due to its optimized perforated structure and appropriate mechanical properties, VCFix® offers an ideal bone-implant interface.

VCFix spinal system pedicle screw for vertebral reconstruction

Stand-alone
Device

Thanks to its robustness, VCFix® allows for the treatment of vertebral compression fractures without the need for bone cement. However, for more severe and unstable fractures, the implant is compatible with cement injection.

Controlled
Anatomic Restoration

VCFix® is available in multiple implant sizes and features an adjustable angular expansion mechanism, supporting controlled fracture reduction and patient-specific anatomic restoration.

Enhanced
Stabilization

VCFix® provides pedicle anchorage to better distribute the biomechanical load on the vertebral body and the spine. In the case of more complex fractures, posterior fixation is an optional feature.

VCFix® System Timeline

2019
Product Initiation

Idea generation and patent protection.

2020
VCFix® Spinal System

VCFix® advanced through early feasibility work and project planning, establishing the foundation for subsequent product development and regulatory engagement.

2021
Breakthrough Device Designation

VCFix® Spinal System receives Breakthrough Device Designation from the U.S. FDA, supporting priority review during development.

2023
First-In-Human Trials

Company successfully completes the First-in-Human clinical trials, including follow-up. (For more information, see the news item.)

2025
Pivotal EXPAND Study

Company receives approval from both the Ethics Committee (EC) and BfArM in Germany for pivotal EXPAND study of the VCFix® Spinal System.

2026
VCFix® Spinal System Launch in US

Introduction of VCFix® Spinal System with cement in the US market.

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