Clinical Information

Indications For Use

TranS1 AxiaLIF® System is intended to provide anterior stabilization of the L5-S1 spinal segment as an adjunct to spinal fusion.

Indications:

Degenerative Disc Disease (DDD)
With or without radicular symptoms
Pseudoarthrosis (unsuccessful previous fusion)
Spondylolisthesis (Grade 1 or 2)

AxiaLIF®: Indications, Contraindications, and Warnings

AxiaLIF®2L: Indications, Contraindications, and Warnings

AxiaLIF® 360°: Indications, Contraindications, and Warnings

Clinical Information

AxiaLIF Indications For Use

CAUTION: Rx Only

INDICATIONS: TranS1® AxiaLIF® System is intended to provide anterior stabilization of the L5-S1 spinal segment as an adjunct to spinal fusion. The AxiaLIF System is indicated for patients requiring fusion to treat pseudoarthrosis (unsuccessful previous fusion) spinal stenosis, spondylolisthesis (Grade 1 or 2), or degenerative disc disease as defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The AxiaLIF System is also intended for minimally invasive access to the anterior portion of the lower spine for assisting in the treatment of degeneration of the lumbar disc, performing lumbar discectomy, or for assistance in the performance of L5-S1 interbody fusion. The AxiaLIF System is not intended to treat severe scoliosis, severe spondylolisthesis (Grades 3 and 4), tumor, or trauma. Its usage is limited to anterior supplemental fixation of the lumbar spine at L5-S1 in conjunction with legally marketed posterior fixation systems.

CONTRAINDICATIONS: Coagulopathy; Bowel disease (e.g. Crohn's, Ulcerative Colitis); Pregnancy; Severe scoliosis; Sacral agenesis; Severe spondylolisthesis (>grade 2); Tumor; Trauma; Do not use with facet screws when correction of spinal stenosis requires removal of significant portions of the lamina or any portion of the facets.

WARNINGS: The risks to the patients are similar to those for patients undergoing any spine stabilization surgery. The most frequently stated risks are bleeding (including occult during and after surgery), neurological damage, damage to soft tissue, spinal cord impingement or damage, infection, loss of bowel or bladder function, loss of erectile or ejaculatory function, meningitis, or pain. Pedicle screw systems, not facet screws, should be considered when there is degenerative disease of the facets with instability. The risks associated with the implant include: breakage of the implants, loosening or expulsion of the implants possibly causing delayed nerve root impingement or damage, fracture of osseous structures, and bursitis. There may be pain, discomfort or abnormal sensations due to the presence of the device. There may be risks associated with harvesting autologous grafts such as pain at the donor site, infection, herniation, and fracture. There may be nonunion or delayed union of fusion with the autologous graft. The safety and effectiveness of this device has not been evaluated in patients with spondylolysis. Pedicle screw systems, not facet screws, should be considered when there is degenerative disease of the facets with instability. The safety and effectiveness of this device has not been evaluated in patients with transitional vertebrae or additional vertebrae (i.e. L6).

PRECAUTIONS:

Preoperative: Portions of this system are supplied non-sterile and need to be cleaned and sterilized according to the CLEANING AND STERILIZATION section of this insert. Care should be taken during the pre-operative preparation to evaluate the ability to achieve a desirable implant trajectory. Severe angulation of the vertebral bodies may make achievement of an effective trajectory difficult. Preoperative planning should include identification of any pre-existing adhesions of the bowel to the sacrum. A bowel perforation could occur during creation of the presacral channel if there is an adhesion of the bowel to the sacrum.

Physicians using the TranS1 AxiaLIF System should have significant experience in spinal surgery, including spinal fusion procedures. Physicians should not independently use the AxiaLIF System prior to participation in specific training on its use.

Postoperative: Risk of occult bleeding exists during and after the procedure. As with all surgical procedures, careful patient monitoring is required to minimize this risk. Following the procedure the patient should be monitored until released for any effects of the procedure. The patient should adhere to post-operative instructions as provided by physician.

Clinical Information

AxiaLIF 2L Indications For Use

CAUTION: Rx Only

INTENDED USE and INDICATIONS: TranS1® AxiaLIF® 2-LEVEL System is intended to provide anterior stabilization of the L4-S1 spinal segments as an adjunct to spinal fusion. The AxiaLIF 2-LEVEL System is also intended for minimally invasive access to the anterior portion of the lower spine for assisting in the treatment of degeneration of the lumbar disc, performing lumbar discectomy, or for assistance in the performance of L4-S1 interbody fusion.

The AxiaLIF 2-LEVEL System is indicated for patients requiring fusion to treat pseudoarthrosis, unsuccessful previous fusion, spinal stenosis, spondylolisthesis (Grade 1), or degenerative disc disease as defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The AxiaLIF 2-LEVEL System is not intended to treat severe scoliosis, severe spondylolisthesis (Grades 2, 3, and 4), tumor, or trauma. The device is not meant to be used in patients with vertebral compression fractures or any other condition where the mechanical integrity of the vertebral body is compromised. Its usage is limited to anterior supplemental fixation of the lumbar spine at L4-S1 in conjunction with legally marketed facet or pedicle screw systems.

CONTRAINDICATIONS: Coagulopathy; bowel disease (e.g. Crohn's, ulcerative colitis); pregnancy; severe scoliosis; sacral agenesis; severe spondylolisthesis (>grade 1); tumor; trauma. Do not use with facet screws when correction of spinal stenosis requires removal of significant portions of the lamina or any portion of the facets.

WARNINGS:

The safety and effectiveness of this device has not been established in patients with osteoporosis. The 3D Axial Rod is used for anterior stabilization but may not remain stable in patients with osteoporosis (defined as a bone density z-score of < - 1.5).

The risks to the patients are similar to those for patients undergoing any spine stabilization surgery. The most frequently stated risks are bleeding (including occult during and after surgery), neurological damage, damage to soft tissue, spinal cord impingement or damage, infection, loss of bowel or bladder function, loss of erectile or ejaculatory function, meningitis, or pain. The safety and effectiveness of this device has not been evaluated in patients with spondylolysis. Pedicle screw systems, not facet screws, should be considered when there is degenerative disease of the facets with instability. The risks associated with the implant include: breakage of the implants, loosening or expulsion of the implants possibly causing delayed nerve root impingement or damage, fracture of osseous structures, and bursitis. There may be pain, discomfort or abnormal sensations due to the presence of the device. There may be risks associated with harvesting autologous grafts such as pain at the donor site, infection, herniation, and fracture. There may be nonunion or delayed union of fusion with the autologous graft.

PRECAUTIONS:

Physicians using the TranS1 AxiaLIF 2-LEVEL System should have significant experience in spinal surgery, including spinal fusion procedures. Physicians should not independently use the AxiaLIF 2-LEVEL System prior to participation in specific training on its use.

Intraoperative: All steps of the procedure should be followed as per the "Surgical Technique". All steps in this technique require the use of active or real time fluoroscopy. Refer to "Surgical Technique" for proper implant sizing. Risk of fluctuation in blood pressure exists in any surgery where instruments are introduced through tubes. Rapid introduction of instruments should be avoided in order to minimize introduction of excessive pressure or air into the disc space. As with any surgical procedure, careful patient monitoring is required to minimize risk.

Revision of the AxiaLIF 2-LEVEL system should not include the use of anterior plates.

Clinical Information

AxiaLIF 360 Indications For Use

CAUTION: Rx Only

INDICATIONS: The TranS1® Facet Screws are to be used in conjunction with the TranS1 AxiaLIF® System which includes the TranS1 3D Axial Rod™, in order to create an anterior/posterior fixation construct as an aid to fusion. The AxiaLIF System is indicated for patients requiring fusion to treat pseudoarthrosis, unsuccessful previous fusion, spinal stenosis, spondylolisthesis (Grade 1 or 2), or degenerative disc disease as defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The AxiaLIF® System is not intended to treat severe scoliosis, severe spondylolisthesis (Grades 3 and 4), tumor, or trauma. Its usage is limited to anterior supplemental fixation of the lumbar spine at L5-S1 in conjunction with legally marketed facet and pedicle screw systems. The facet screws may be implanted using one of two techniques: transfacetpedicular or translaminar. The screws are inserted bilaterally through the superior side of the facet, across the facet joint and into the pedicle. Alternatively, the facet screws may be cross inserted from the base of the spinous process into the opposite lamina and across the facet joint into the base of the lower vertebral transverse process.

CONTRAINDICATIONS: The contraindications include but are not limited to: TranS1 Facet Screws should not be used when the correction of spinal stenosis requires the removal of significant portions of the lamina or any portion of the facets. Active infection process or significant risk of infection (immunocompromise). Signs of local inflammation. Fever or leukocytes. Morbid obesity. Pregnancy. Mental Illness. Grossly distorted anatomy caused by congenital abnormalities. Any medical or surgical condition which would preclude the potential benefit of spinal implant surgery, such at the presence of tumors or congenital abnormalities, elevation of sedimentation rate unexplained by other diseases, elevation in the WBC differential count. Rapid joint disease, bone absorption, osteopenia, and/or osteoporosis. Osteoporosis is a relative contraindication since this condition may limit the degree of obtainable correction and/or the amount of mechanical fixation. Suspected or documented metal allergy or intolerance. Any case where metals must be mixed from different components. Any case where the implant components selected for use would be too large or too small to achieve a successful result. Any case where a bone graft and fusion is unnecessary or where fracture healing is not required. Any patient having inadequate tissue coverage over the operative site or where there is inadequate bone stock, bone quality, or anatomical definition. Any patient in which implant utilization would interfere with anatomical structures or physiological performance. Any patient unwilling to follow post-operative instructions. Any case not described in the indications.

WARNINGS and PRECAUTIONS:The safety and effectiveness of this device has not been evaluated in patients with spondylolysis. Pedicle screw systems, not facet screws, should be considered when there is degenerative disease of the facets with instability. Correct selection of the implant is extremely important. The potential for success is increased by the selection of the proper size, shape, and design of the implant. While proper selection can minimize risks, the size and shape of human bones present limitations on the size and strength of implants. Metallic internal fixation devices cannot withstand the activity levels and/or loads equal to those placed on normal, healthy bone. These devices are not designed to withstand the unsupported stress of full weight or load bearing. A higher risk of device loosening, bending, or breaking exists with fractures involving severe comminution, displacement, or other difficult medical situations. These devices can break when subjected to the increased loading associated with delayed union, or nonunion. Internal fixation appliances are load sharing devices, which stabilize and hold a spinal segment in alignment until healing occurs. If healing is delayed, or does not occur, the implant will eventually loosen, bend, or break. Loads on the device produced by load bearing, and the patient's activity level will dictate the longevity of the implant. Corrosion of the implant can occur. Implanting metals and alloys in the human body subjects them to constantly changing environment of salts, acids, and alkalis, which can cause corrosion. Placing dissimilar metals in contact with each other can accelerate the corrosion process, which in turn can enhance fatigue fractures of implants. Thus, every effort should be made to use compatible metals and alloys in conjunction with each other. Surgical implants must never be reused. An explanted implant should never be reimplanted. Even though the device may appear undamaged, it may have small defects and internal stress patterns which may lead to early breakage. Metallic implants can loosen, bend, fracture, corrode, migrate, cause pain or stress shield bone even after healing has occurred. If a device remains implanted after complete healing, it may increase the risk of refracture in an active individual. Therefore, these devices are temporary and may be removed after completing their intended function-aiding in the bone graft healing process. The surgeon should weigh the risk versus benefit when deciding whether to remove an implant. Implant removal should be followed by adequate postoperative management. If the patient is older and has a low activity level, the surgeon may elect not to remove the implant, thus eliminating the risks associated with a second surgery.

Physicians using the TranS1 Facet Screws should have significant experience in spinal surgery, including spinal fusion.

POSSIBLE ADVERSE EVENTS: All of the adverse events associated with general surgery or spinal fusion surgery are possible. With instrumentation, a listing of possible adverse events includes but is not limited to: Early or late loosening of any or all of the components. Disassembly, bending, and/or breakage of any or all of the components. Foreign body (allergic) reaction to implants, debris, corrosion products including metallosis, staining, tumor formation, and/or auto-immune disease. Pressure on the skin from component parts in patients with inadequate tissue coverage over the implant possibly causing skin penetration, irritation, and/or pain. Bursitis. Tissue damage caused by improper positioning and placement of implants or instruments. Post-operative change in spinal curvature, loss of correction, height, and/or reduction. Infection. Dural tears. Loss of neurological function, including paralysis (complete or incomplete), dysesthesias, hyperesthesia, anesthesia, paraesthesia, appearance of radiculopathy and/or the development or continuation of pain, numbness, neuroma, or tingling sensation. Cauda equine syndrome, neuropathy, neurological deficits (transient or permanent), bilateral paraplegia, reflex deficits, and/or arachnoiditis. Urinary retention or loss of bladder control or other types of urological system compromise. Scar formation possibly causing neurological compromise around nerves and/or pain. Fracture, microfracture, resorption, damage, or penetration of any spinal bone (including the sacrum, pedicles, spinous process, and/or vertebral body) and/or bone graft or bone graft harvest site at, above, and/or below the level of surgery. Non-union (or pseudarthrosis). Delayed union. Mal-union. Cessation of any potential growth of the operated portion of the spine. Loss of spinal mobility or function. Inability to perform activities of daily living. Bone loss or decrease in bone density, possibly caused by stress shielding. Graft donor site complications including pain, fracture, or wound healing problems. Herniated nucleus pulposus, disc disruption or degeneration. Hemorrhage, hematoma, occlusion, seroma, edema, hypertension, embolism, stroke, excessive bleeding, phlebitis, wound necrosis, wound dehiscence, damage to blood vessels, or other types of cardiovascular system compromise. Ileus, gastritis, bowel obstruction or loss of bowel control or other types of gastrointestinal system compromise. Reproductive system compromise such as sterility, loss of consortium, and sexual dysfunction. Development of respiratory problems, e.g. pulmonary embolism, atelectasis, bronchitis, pneumonia, etc. Change in mental status. Death. Additional surgery may be necessary to correct some of these adverse events.

Caution:

Preoperative: Only patients that meet the criteria described in the indications should be selected. Patient conditions and/or predispositions such as those addressed in the aforementioned contraindications should be avoided. Care should be used in handling and storing of the implant components. The implants should not be scratched or otherwise damaged. Implants and instruments should be protected during storage, especially from corrosive environments. An adequate inventory of implants should be available at the time of surgery, normally a quantity in excess of what is expected to be used. Since mechanical parts are involved, the surgeon should be familiar with the various components before using the equipment and should personally assemble the devices to verify that all parts and necessary instruments are present before the surgery begins. The TranS1 Facet Screws are not to be combined with the components from another manufacturer. Different metal types should never be used together. All components and instruments should be cleaned and sterilized before use. Additional sterile components should be available in case of unexpected need.
Intraoperative:Extreme caution should be used around the spinal cord and nerve roots. Damage to the nerves will cause loss of neurological functions. Breakage, slippage, or misuse of instruments or implant components may cause injury to the patient or operative personnel. Whenever possible or necessary, an imaging system should be utilized to facilitate surgery. Caution: Do not overtap or use a screw that is too long or too large. Overtapping or using an incorrectly sized screw may cause nerve damage, hemorrhage, or the other possible adverse events listed elsewhere in this package insert. Bone graft may be placed in the area to be fused and graft material must extend from the upper to the lower vertebrae being fused.

Postoperative: The physician's postoperative directions and warnings to the patient, and the corresponding patient compliance, are extremely important. Detailed instructions on the use and limitations of the device should be given to the patient. If partial weight- bearing is recommended or required prior to firm bony union, the patient must be warned that bending, loosening and/or breakage of the device(s) are complications which may occur as a result of excessive or early weight-bearing or muscular activity. The risk of bending, loosening, or breakage during rehabilitation may be increased if the patient is active, debilitated, or demented. The patient should be warned to avoid falls or sudden jolts. To allow the maximum chances for a successful surgical result, the patient or devices should not be exposed to mechanical vibrations or shock that may loosen the device. The patient should be warned of this possibility and instructed to limit and restrict physical activities, especially lifting and twisting motions and any type of sport participation. The patient should be advised not to smoke tobacco or utilize nicotine products, or to consume alcohol or non-steroidals or anti-inflammatory medications during the bone graft healing process. The patient should be advised of their inability to bend or rotate at the point of spinal fusion and taught to compensate for the permanent restriction in motion. Failure to immobilize a delayed or non- union of bone will result in excessive and repeated stresses on the implant. By the mechanism of fatigue, these stresses can cause bending, loosening, or breakage of the device(s). It is important that immobilization of the spinal surgical site be maintained until firm bony union is established and confirmed by roentenographic examination. If a state of non-union persists or if the components loosen, bend, and/or break, the device should be revised and/or removed before serious injury occurs. The patient must be adequately warned of these hazards and closely supervised to ensure cooperation until bony union is confirmed. As a precaution, before patients with implants receive any subsequent surgery (such as dental procedures), prophylactic antibiotics may be considered, especially for high risk patients. Any retrieved devices should be treated in such a manner that reuse in another surgical procedure is not possible. As with all orthopedic implants, the TranS1® Facet Screws should never be reused under any circumstances.