Orthopedic Device Testing
JTL America provides a wide variety of mechanical testing for orthopedic devices including implants, instruments, and materials. Our test reports are routinely used for submission to the FDA as well as global regulatory bodies in Europe, South America, and Asia.
In addition to performing the tests, JTL’s experts will guide you through the required tests for your specific device, even if no published methodology exists. Furthermore, we continue offering support following the submission of your device. We continue this support by offering expert advice to address the inevitable questions that arise during the regulatory evaluation process.
You can read more about specific orthopedic devices and testing standards below or contact us for a fast quote today.
Material Testing for Medical Devices for Trauma and Extremities
One of the fastest growing market segments are trauma and extremity devices. Simple devices such as bone plates and screws are subjected to routine tests such as bending and pullout. Complex devices such as reverse shoulders are subjected to more complex biaxial loading to evaluate loosening, fatigue, and fretting potential at modular junctions. Contact JTL America today to discuss the latest industry trends in testing for your next shoulder, elbow, wrist, or ankle devices. Some commonly tested devices are listed below:
- Total ankle systems
- Bone plates and screws
- Reverse and anatomic shoulder systems
- Small bone systems (foot and ankle, hand plating systems)
Hip and Knee Implants
Mechanical testing for large joints is multifaceted, with standards to address fatigue properties of load bearing members, disassembly forces between mating components, range of motion between articulating and sliding components, and wear debris generated from relative motion. Some commonly tested hip and knee devices are listed below.
- Hip stems (cemented, press fit, modular)
- Acetabular shells and liners
- Taper connections
- Tibial trays and liners
- Femoral components
- Unicondylar components
While numerous standards exist for common devices such as cages, plates, and screws, the pace of device development in spine far exceeds the development of standards that govern how they are tested. Combined with evolving requirements from regulatory bodies, bringing a new spinal implant to market is a daunting task. JTL America can help.
Contact us to discuss a comprehensive and streamlined approach to testing your new spinal implant. Some commonly tested orthopedic spinal devices are listed below:
- Cervical and lumbar plating systems
- Lumbar pedicle screws
- OCT plate and screw systems
- Spinal spacers (IBFD and VBR)
- Interspinous spacers
Testing For Medical Equipment Materials And Coatings
The test program for porous coatings is very well defined and includes static tensile strength, static shear strength, shear fatigue strength, bending fatigue strength, abrasion resistance, as well as requirements for porosity. This applies to HA coatings, sintered beads, plasma sprayed Ti, as well as new technology such as metal scaffolding and 3D printed porous structures.
In addition to coating tests, JTL routinely performs material testing for lot validation, new equipment validation, as well as manufacturing process evaluation. Recent projects include an evaluation of peening operations on CoCr, the influence of various laser marking parameters on spinal rods, and an evaluation of the influence of hot isostatic pressing on the fatigue life of 3D printed material.
Testing for Cranial, Maxillofacial, and Dental Devices
Aside from very standardized test methods for dental implants, this category of implants is not well defined in terms of performance requirements. JTL America can help. Whether you’re testing a resorbable bone screw, 3D printed cranial plate, or an orbital mesh, you can count on JTL America’s experience with these devices to guide you through the necessary steps. Some commonly tested devices are listed below:
- Dental implants (including “mini” systems)
- Cranial plating systems
- TMJ joint replacement
- Sternal closure systems
Material Testing for Surgical Instruments
With no published test methods, manufacturers are left to their own devices to validate surgical instruments. At the same time, regulatory bodies have been requiring more testing to ensure instruments can withstand both the abuse experienced during surgery, as well as the harsh conditions under which instruments are cleaned and sterilized.
JTL America offers a wide variety of services to help validate your surgical instruments including:
- Cyclic cleaning and sterilization testing
- Repetitive impact testing up to 7000lbf for devices such as broach handles, cup impactors, and bone tamps
- Cutting efficiency and life cycle testing for drills, reamers, and other cutting instruments
- Cyclic torsional testing for torque transmitting devices such as screwdrivers, flex shafts and torque limiters