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CopiOs™ BVF, in combination with autologous bone marrow, is intended for use only for filling bone voids or gaps of the skeletal system (ie, extremities, pelvis, spine) that are not intrinsic to the stability of the bone structure. These voids may be a result of trauma or creation by surgeon. CopiOs™ BVF is intended to be gently packed into the void or gap and will resorb during the course of the healing process.

CopiOs™ BVF is a synthetic bone graft material consisting of mineralized, lyophilized collagen that has been formed into three-dimensional pads of various sizes for surgical implantation. The CopiOs™ BVF product sponge consists of dehydrothermally (DHT) cross-linked bovine dermal collagen mixed with calcium phosphate salt. The pads are approximately 67% mineral by weight. The fibrous collagen mixed with the calcium phosphate salt is cast into sponges as described in this application. The average porosity of the product was determined to be 93.39%, which allows for favorable conditions for cell migration and adherence to the collagenous matrix. Further, the calcium phosphate provides the mineral required for osteogenesis and the specific CopiOs™ BVF formulation provides a pH environment conducive for osteoinduction.

When used as a pedicle screw fixation system in skeletally mature patients, the DYNESYS Spinal System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, kyphosis, and failed previous fusion (pseudoarthrosis). In addition, when used as a pedicle screw fixation system, the DYNESYS Spinal System is indicated for use in patients: - Who are receiving fusions with autogenous graft only; a) - b) Who are having the device fixed or attached to the lumbar or sacral spine; and - c) Who are having the device removed after the development of a solid fusion mass.

The DYNESYS® Spinal System consists of four pedicle screws, two cords and two spacers in a symmetric, bilateral arrangement. The pedicle screws are placed lateral to the facet joints with two screws in the cephalad position and two screws in the caudad position. The superior-inferior distance between the pedicle screws is maintained with the spacers. The cord passes through the eye of the pedicle screw heads and through the centers of the spacers.

The Spine-Tech™ Cement Restrictor is intended for use as a cement restrictor in orthopedic surgeries such as those involving the femoral canal and tibial plateau in hip stem and total knee replacement. The Spine-Tech™ Cement Restrictor is NOT intended for any spinal indications.

The Spine-Tech™ Cement Restrictor is a threaded, hollow cylinder that is manufactured from PEEK Optima LT1 with carbon fiber. This device is intended to be used in conjunction with PMMA cement.

The Trinica Select™ Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine at levels C2-T1. The System is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthrosis, and/or failed previous fusions. WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

The Trinica Select Anterior Cervical Plate System is a fixation device consisting of cervical plates, locking caps, fixed bone screws and variable angle bone screws made from titanium alloy in conformance with ASTM F136. The locking cap is preassembled onto the plate and is designed with tabs that prevent bone screws from backing out. The plates and locking caps are treated with titanium anodization per AMS (Aerospace Material Specification) 2488 Type II. Bone screws are subjected to a color anodizing process to differentiate the screw type and diameter Plates are offered in one-level, two-level, and four-level fusion configurations (22 mm through 92 mm). Bone screws are available in lengths from 10mm through 18mm in 1mm increments. The screws have either a 4.2 inch 4.6 inch diameter. Fixed angle and variable angle screws are available.

The Spine-Tech Silhouette Spinal Fixation System, when used as a pedicle screw fixation system, is indicated for use in patients: a) having severe spondylolisthesis (Grade 3 and 4) at the LS-S1 joint; b) who are receiving fusion using autogenous graft only; c) who are having the device fixed or attached to the lumbar or sacral spine; and d) who are having the device removed after the development of a solid fusion mass. When used for this indication, the fusion mass may not go above the L5-S1 joint, the levels of pedicle screw fixation may span from L3 to the sacrum. When used as a hook and sacral screw system, the Spine-Tech Silhouette Spinal Fixation System is intended for use in the treatment of degenerative disc disease (as defined by history and radiographic studies), idiopathic scoliosis, spondylolisthesis, kyphotic or lordotic deformity of the spine, loss of stability due to tumors, spinal stenosis, vertebral fracture or dislocation, pseudoarthrosis, and previous failed spinal fusion. When used for sacral/iliac attachment only, screws of the Spin-Tech Silhouette Spinal Fixation System are intended for sacral/iliac attachment only. Hook and transverse connectors of the system are intended for posterior thoracic and/or lumbar use only. As a whole, the levels of use for hook and sacral screw fixation of this system are T1 to the sacrum.

The Spine-Tech Silhouette™ Spinal Fixation System is a temporary implant system used to correct spinal deformity and facilitates the biological process of the spine. This system is intended for posterior use in the thoracic, lumbar and sacral regions of the spine. Implants of this system consist of hooks and/or screws, polyaxial screws of varying diameters and lengths, fixed screws of varying diameters and lengths, rods in varying lengths, hooks in varying designs, and transverse connectors, both fixed and variable. All implants in this system are top loading and top tightening. The implants in this system are manufactured from titanium alloy (Ti-6A1-4V), conforming to ASTM F-136. The implants of this system are for single use only. An implant should never be reused after being removed from the body or sterilized after coming into contact with body fluids or tissues.

The Spine-Tech Bone Harvester is indicated for the cutting and collection of morselized autogenous bone graft from the anterior or posterior iliac crest, tibia or femur. This device is intended to cut and collect finely morselized autogenous bone graft for any surgical procedure requiring bone graft to facilitate fusion and/or fill bone defects. These procedures include; spinal fusion, joint arthrodesis, total joint replacement, fracture repair, maxillofacial reconstruction and tumor removal. All components of the Spine-Tech Bone Harvested are intended for single use only.

The Spine-Tech Bone Harvester consists of two cutting head/collection tube sizes, Hudson or Hall fitting adapter for power use, trocar and plunger. The cutting heads and trocar are constructed from stainless steel. The collection tube and adapter are constructed from medical grade polycarbonate. The plunger is constructed from acetal copolymer. After cutting and collection of morselized bone graft, the cutting head is removed from the collection tube with the trocar and bone is pushed out of the collection tube with the plunger.