Mechanical performance of thoracolumbosacral pedicle screw systems: An analysis of data submitted to the Food and Drug Administration.

Thoracolumbosacral pedicle screw systems (TPSSs) are spinal implants commonly utilized to stabilize the spine as an adjunct to fusion for a variety of spinal pathologies. These systems consist of components including pedicle screws, rods, hooks, and various connectors that allow the surgeon to create constructs that can be affixed to a wide range of spinal anatomy. During the development and regulatory clearance process, TPSSs are subjected to mechanical testing such as static and dynamic compression bending per ASTM F1717, axial and torsional grip testing per ASTM F1798, and foam block pullout testing per ASTM F543.

Development of an in vitro test method to simulate intra-operative impaction loading on lumbar intervertebral body fusion devices.

Intervertebral body fusion devices (IBFDs) are commonly used in the treatment of various spinal pathologies. Intra-operative fractures of polyether-ether-ketone (PEEK) implants have been reported in the literature and to the FDA as device-related adverse events. The device and/or implant inserter failures typically occur during device impaction into the disc space and require implant removal and replacement.

Assessing the use of finite element analysis for mechanical performance evaluation of intervertebral body fusion devices.

Background: Intervertebral body fusion devices (IBFDs) are a widely used type of spinal implant placed between two vertebral bodies to stabilize the spine for fusion in the treatment of spinal pathologies. Assessing mechanical performance of these devices is critical during the design, verification, and regulatory evaluation phases of development. While traditionally evaluated with physical bench testing, empirical assessments are at times supplemented with computational models and simulations such as finite element analysis (FEA).

Mechanical performance of lumbar intervertebral body fusion devices: An analysis of data submitted to the Food and Drug Administration.

Lumbar intervertebral body fusion devices (L-IBFDs) are intended to provide stability to promote fusion in patients with a variety of lumbar pathologies. Different L-IBFD designs have been developed to accommodate various surgical approaches for lumbar interbody fusion procedures including anterior, lateral, posterior, and transforaminal lumbar interbody fusions (ALIF, LLIF, PLIF, and TLIF, respectively). Due to design differences, there is a potential for mechanical performance differences between ALIF, LLIF, PLIF, and TLIF devices.

Mechanical performance of cervical intervertebral body fusion devices: A systematic analysis of data submitted to the Food and Drug Administration.

Cervical intervertebral body fusion devices (IBFDs) are utilized to provide stability while fusion occurs in patients with cervical pathology. For a manufacturer to market a new cervical IBFD in the United States, substantial equivalence to a cervical IBFD previously cleared by FDA must be established through the 510(k) regulatory pathway. Mechanical performance data are typically provided as part of the 510(k) process for IBFDs.

Biomechanical evaluation of an integrated fixation cage during fatigue loading: a human cadaver study.

OBJECTIVE Lumbar cages with integrated fixation screws offer a low-profile alternative to a standard cage with anterior supplemental fixation. However, the mechanical stability of integrated fixation cages (IFCs) compared with a cage with anterior plate fixation under fatigue loading has not been investigated. The purpose of this study was to compare the biomechanical stability of a screw-based IFC with a standard cage coupled with that of an anterior plate under fatigue loading.

Impact of screw location and endplate preparation on pullout strength for anterior plates and integrated fixation cages.

Background Context: Numerous integrated fixation cages (IFCs) have recently been introduced to the market with "zero-profile" designs that incorporate screw fixation through the vertebral endplate. It is unclear whether differences in bone quality and quantity in this insertion location may affect fixation compared with screws used in traditional anterior plate (AP) fixation. Moreover, endplate preparation for IFC implantation may affect fixation strength.