Vendor/Manufacturer: Spineology
Product/Product Line: Threshold™ Pedicular Fixation System
FDA Regulation Medical Specialty: Orthopedic Devices - Prosthetic Devices
FDA Regulation Number: 888.3070
FDA Regulation Description Classification Name:
Pedicle Screw Spinal System
FDA Classification Product Code: NKB
FDA Classification Product Code Device Name:
Thoracolumbosacral Pedicle Screw System
SUBSTANTIALLY EQUIVALENT to the following products:
Device Description:
Spineology Fortress™, Threshold™, Threshold™ V2, and Palisade™ Pedicular Fixation Systems consist of screws (titanium alloy), curved and straight rods (see table below for diameters and material), and ConneX™ Connector (see table below for configurations and materials) devices to allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. All screws are available with or without a hydroxyapatite coating.
These systems are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine. The screws can be placed in the pedicles in a variety of trajectories ranging from the standard anatomic transpedicular path projected medially toward the ventral vertebral body, to a caudocephalad path sagittally and a laterally directed path in the transverse plane.
Indications for Use:
Spineology Pedicular Fixation Systems are intended for posterior, non-cervical fixation as an adjunct to fusion in skeletally mature patients for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudoarthrosis; and/or failed previous fusion.
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