Orthopedic Implants Mechanical Testing Solutions

The mechanical testing of orthopedic implants involves various methods to assess the implants strength, durability, and performance. Common tests include tension, compression, bend, fatigue, torsion and wear. These tests are crucial to ensuring the implants’ safety and efficacy. The U.S. Food and Drug Administration (FDA) categorizes medical devices into Class I, II, or III based on their risks and the regulatory controls necessary to provide a reasonable assurance of safety and effectiveness. Testing standards for medical devices are often developed for the specific medical device to be tested, as desired biomechanical properties per material and per application vary.

ADMET testing systems are trusted by leading medical device manufacturers, universities, and research laboratories to determine the mechanical properties and endurance limits of biomaterials, medical devices and implants. Our systems meet FDA 21 CFR part 11 requirements and are capable of performing static and fatigue tests in tension, compression, bending, torsion, axial-torsion and planar biaxial according to ASTM and ISO standards. Our ability to design a system to fit specific needs allows ADMET to provide testing solutions for even the most unique and demanding applications.

Common Orthopedic Implants that Require Mechanical Testing

Metallic bone plate

Bone Plates

Used to stabilize broken bones, bone plates are fixed to the bone with screws to hold it in the correct position as it heals. They are designed to be biocompatible and provide mechanical support. Mechanical testing of bone plates includes assessing their bending strength, bending stiffness, fatigue resistance, and compatibility with bone materials.

medical bone screw

Bone Screws

Bone screws are used in surgical procedures to secure implants such as plates or rods, stabilize fractures, or facilitate bone fusion. They must be engineered with precise mechanical characteristics to enable secure fixation. Bone screws used in orthopedic applications undergo mechanical testing to assess their load-bearing capacity, pull-out strength, torque resistance, and fatigue behavior.

dental implant close up

Dental Implants

A dental implant is a metal post, usually made of titanium, that replaces the root portion of a missing tooth. It serves as an anchor for artificial teeth and requires stringent mechanical testing to ensure stability and functionality. Dental implants are subjected to mechanical testing to evaluate their structural strength by calculating their load-bearing and bending capacity, and fatigue resistance.

hip implant xray

Hip Implants

Hip implants are prosthetic devices used to replace a damaged or deteriorated hip joint. These orthopedic devices must be meticulously designed to mimic the natural movement of the hip and withstand long-term wear. Mechanical testing of hip implants is crucial to determine their load-bearing capacity, wear resistance and overall performance.

medically accurate illustration of the knee anatomy

Knee Prosthesis

Knee prostheses are artificial substitutes for the knee joint used in knee replacement surgeries. These devices are designed to replicate the complex movements of the knee and provide durable functionality. Knee prostheses undergo mechanical testing to evaluate their durability, load-bearing capability, and fatigue resistance, showing the capability of the device to withstand the expected loads over a specified time.

Artificial Should Implant close up

Shoulder Implants

Shoulder implants are orthopedic prosthetic devices that are intended for use as a replacement to damaged shoulder joints. Shoulder implants must be designed to restore the full range of motion and bear the mechanical load associated with arm movement. Shoulder implants undergo mechanical testing to assess their load-bearing capacity, wear resistance, and overall stability.

Spinal Implants

Utilized in spinal surgeries to correct deformities or stabilize the spine, spinal implants may include rods, screws, plates, and cages. They must be designed to align with the complex biomechanics of the spine. Mechanical testing of spinal implants involves evaluating their fatigue resistance, stability, and load-bearing capacity.

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Common Orthopedic Implant Test Types & Standards:

ASTM F543 bone screw insertion torque test

Axial-Torsion Testing

Axial torsion testing assesses the performance of orthopedic implants under combined axial (linear) and torsional (rotational) loads. Essential for devices like bone screws or hip implants, this testing ensures that they can withstand both twisting and compressive forces in the body. It plays a crucial role in determining the device’s functionality, reliability, and safety.