Capture Facet Fixation System
Minimally invasive, bone-sparing surgical methods and load-bearing interbody fusion systems have dramatically altered the biomechanical demands placed on fixation systems, reducing the need for large complex spinal fixation constructs for many patients. The Capture Facet Fixation System is the perfect complement.
Implanted with intuitive percutaneous over-the-wire methods, the Capture system features superb implant control, excellent tactile response when seating the screw, head serrations to “grip” the bony cortex, and full-thread or lag screw options. In all, minimally complex, minimally invasive fixation.
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Capture Product Labeling
INTENDED USE / INDICATIONS FOR USE
The Spineology Facet Screw System is intended to stabilize the spine as an aid to fusion by transfacet fixation.
The device is indicated for posterior surgical treatment of any or all of the following at the L1 to S1 (inclusive) spinal levels: Spondylolisthesis, Pseudoarthrosis or failed previous fusions which are symptomatic; Degenerative Disc Disease (DDD) as defined by back pain of discogenic origin with degeneration of disc confirmed by history and radiographic studies and/or degenerative disease of the facets with instability.
For a complete listing, see package insert.
OptiMesh Labeling
INTENDED USE / INDICATIONS
OptiMesh is a surgical mesh intended to contain and reinforce bone grafting materials and/or bone graft substitutes in bony voids or gaps of the skeletal system (i.e., the extremities, spine, and pelvis). These voids or gaps may be surgically created osseous defects, natural gaps, or defects partially surrounded by bone, defects created from traumatic injury, or a combination thereof. Adjunct fixation is recommended in cases involving segmental instability.
OptiMesh is indicated for use in orthopedic grafting procedures, including the following:
Lumbar interbody fusion: The OptiMesh 1500 System is used to contain, enhance the compaction of, and stabilize and reinforce bone graft material used in the intervertebral space of patients undergoing fusion to treat degenerative disc disease at one spinal level from L2-S1. For this use, OptiMesh 1500 is to be used in conjunction with stabilizing posterior fixation.
Thoracolumbar vertebral body fractures: OptiMesh 1500 with allograft is intended for vertebral augmentation, including fracture reduction, for the treatment of painful insufficiency fractures of the vertebral body due to osteoporosis, minor trauma or benign lesions.
It is also intended for the treatment of painful traumatic vertebral fractures which are either a) clinically stable upon presentation, or b) are surgically stabilized with posterior fixation.
For a complete listing, see package insert.
Granular Mechanics
A subspecialty of physics known as Granular Mechanics describes the unique physical characteristics of granular materials.
One useful characteristic of granular materials is their properties change when contained, i.e., flowable (liquid-like) to solid. OptiMesh utilizes this principle.
In an open environment, like the cannulae used to deliver bone into an OptiMesh, the bone granules can flow like a liquid and be pressurized to generate hydraulic-like lifting capabilities. Yet, when a space is enclosed, like the inside of an OptiMesh, the graft granules can be so densely compacted they point load and form force chains, making the graft pack act like a load-bearing solid structure.
