Orthotek Laboratory

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Spinal Implants

Spine Components

ASTM F 2193: Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System.

Spine Part Constructs Test

ASTM F 1798: Evaluation of the static and fatigue properties of interconnection mechanisms and subassemblies used in spinal arthrodesis implants.

ISO 12189: Implants for surgery — Mechanical testing of implantable spinal devices — Fatigue test method for spinal implant assemblies using an anterior support.

Spine

The spinal device segment is one of the fastest growing in the biomedical industry, and growth is expected to continue with the development of new and innovative devices. Orthotek can meet your spinal device testing requirements, on time and within budget.

Spinal implants are generally grouped as fusion or non-fusion devices. Accutek provides services for both types of implants, according to ASTM specifications such as ASTM F1717 and ASTM F2077, among many others.

Spine Corpectomy Model Test

ASTM F 1717: Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model.

Spinal Cage Test

ASTM F 2077: Test Methods For Intervertebral Body Fusion Devices.

Spinal Disc Wear Test

ISO 18192-1: Test Implants for surgery — Wear of total intervertebral spinal disc prostheses — Part 1: Loading and displacement parameters for wear testing and corresponding environmental conditions for test.

ISO 18192-2: Implants for surgery — Wear of total spinal intervertebral disc prostheses — Part 2: Nucleus replacements.

Spine Subsidance Test

ASTM F 2267: Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression.

Other Test

ASTM F 2624: Standard Test Method for Static, Dynamic, and Wear Assessment of Extra-Discal Spinal Motion Preserving Implants.

ASTM F 2694: Standard Practice for Functional and Wear Evaluation of Motion-Preserving Lumbar Total Facet Prostheses.

ASTM F 2790: Standard Practice for Functional and Wear Evaluation of Motion-Preserving Lumbar Total Facet Prostheses.

ASTM F 2706: Standard Test Methods for Occipital-Cervical and Occipital-Cervical-Thoracic Spinal Implant Constructs in a Vertebrectomy Model.

FINITE ELEMENT

ANALYSIS

IMPLANT TESTING

SICENTIFIC