INDICATIONS, SAFETY, AND WARNINGS Titan Endoskeleton™ Cervical Products

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ENDOSKELETON™ TC INTERBODY FUSION IMPLANTS

DESCRIPTION

The Endoskeleton TC Interbody Fusion implants are designed with a large hollow region in the center to house autograft bone, allograft bone  comprised of  cancellous and/or corticocancellous bone, demineralized allograft with bone marrow aspirate, or a combination thereof. The new  bone formation through the implant is intended to provide long-term  structural support and fusion at the implanted disc space. The design  incorporates “windows” through the implant to permit visualization of the graft material and over time formation of new bone. The superior and inferior surfaces include either the  Chemtex® surface treatment or nanoLOCK surface treatment (MMN) designed to improve fixation to the adjacent bone. The nanoLOCK surface technology (MMN) provides a microscopic roughened surface with nano-scale features. The implants are composed of ASTM F136 Ti 6AI-4V ELI titanium alloy and are provided either sterile or non-sterile.

An implant holding feature has been incorporated into the trailing surface of the implant to mate with the implant holder, and to facilitate placement of the implant into the  interbody space.

INDICATION FOR USE

The Endoskeleton TC is indicated for use for anterior cervical interbody  fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical  spine at one disc level from C-3 to C-7. DDD is defined  as discogenic pain with degeneration of the disc confirmed by history  and radiographic studies. Patients should have received 6 weeks of non- operative treatment prior to treatment with the device. The Endoskeleton  TC is indicated to be used with supplemental fixation that has been cleared  by the FDA for use in the cervical spine and be used with autograft bone  and/or allograft bone comprised of cancellous and/or corticocancellous  bone and/or demineralized allograft bone with bone marrow aspirate.

WARNINGS

In using metallic implants, the surgeon should be aware of the following:

  1. The 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.
  2. The surgeon must ensure that all necessary implants and instruments are on hand prior to surgery. An adequate inventory of implant sizes should be available at the time of surgery, including sizes that are larger and smaller than those expected to be used.
  3. The correct handling of the implant is extremely important. Contouring of the implant is to be avoided.
  4. The ENDOSKELETON™ TC Interbody Fusion System has not been evaluated for safety and compatibility in the MR environment.  It has not been tested for heating, migration, or image artifact in the  MR environment. The safety of Endoskeleton TC Interbody Fusion  Device in the MR environment is unknown. Scanning a patient  who has this device may result in patient injury.

CONTRAINDICATIONS

  1. As with all orthopedic implants, the ENDOSKELETON™ TC Interbody Fusion Device should never be reused under any circumstances. Reuse may result in, but is not limited to the following; infection or bending, loosening or breakage due to impairment of implant integrity.
  2. The Endoskeleton™ TC Interbody Fusion Device should never be implanted in patients with a systemic or local infection.
  3. The Endoskeleton™ TC system should not be used with components of any other interbody systems. Supplemental fixation must be used.
  4. The Endoskeleton™ TC device should not be implanted in patients with an allergy to titanium or titanium alloys.
  5. All patients should have at least 6 weeks of non‐operative care prior to spinal fusion with the Endoskeleton™ TC device.
  6. The Endoskeleton™ TC Interbody Fusion Device should not be implanted in patients with a prior fusion to the level to be treated.

PRECAUTIONS

Preoperative:

  1. Only patients that meet the criteria described in the indication should be selected.
  2. Based on fatigue testing results, when using the Endoskeleton™ TC Interbody Fusion Device, the physician/surgeon should consider the levels of implantation, patient weight, patient activity level, other patient conditions, etc., which may impact on the performance of this system.
  3. Safety and effectiveness has not been established in patients with the following conditions: morbid obesity; symptomatic cardiac disease; pregnancy; signs of local inflammation; fever or leukocytosis; metal sensitivity/allergy to the implant materials; any medical or surgical condition which would preclude the potential benefit of spinal implant surgery, such as the elevation of sedimentation rate unexplained by other diseases, elevation of white blood count (WBC), or a marked left shift in the WBC differential count; grossly distorted anatomy due to congenital abnormalities; osteopenia, and/or osteoporosis (osteoporosis is a relative contraindication since this condition may limit the obtainable correction, the amount of mechanical fixation, and /or the quality of the bone graft); long term systemic corticosteroid use; active drug abuse; any case requiring the mixing of metals from different components; any patient having inadequate tissue coverage over the operative site or where there is inadequate bone stock, bone quality, or anatomical definition; any patient unwilling to cooperate with the postoperative instructions; any time implant utilization would interfere with anatomical structures or expected physiological performance. Patient conditions and/or predispositions such as these should be avoided. Other conditions may exist where safety and effectiveness have not been established.
  4. Care should be used in handling and storage of the implants and instruments. The implants should not be scratched or otherwise damaged. Implants and instruments should be  protected during storage especially from corrosive environments. Devices should  be  routinely inspected; if they exhibit wear, damage, corrosion,  or discoloration they should be  returned to Titan Spine for  further evaluation.
  5. The type of construct to be assembled for the case should be determined prior to beginning the surgery.
  6. Because mechanical parts are involved, the surgeon should be familiar with the various components before using the equipment and should personally assemble the implants to verify that all parts and necessary instruments are present before the surgery begins.
  7. Proper implant selection and patient compliance to postoperative precautions will greatly affect surgical outcomes. Patients who smoke have been shown to have an increased incidence of nonunion. Therefore, these patients should be advised of this fact and warned of the potential consequences.
  8. Postoperative care is important. The patient should be instructed in the limitations in the limitations of his/her metallic implant(s) and should be  cautioned regarding weight bearing and body stress  on the  appliance prior to secure bone healing.

Intraoperative:

  1. Any instruction manuals should be carefully followed.
  2. At all times, extreme caution should be used around the spinal cord and nerve roots. Damage to nerves may occur resulting in loss of neurological functions.
  3. The implant surfaces should not be scratched or notched since such actions may reduce the functional strength of the construct.
  4. Either autograft, cancellous and/or corticocancellous allograft, demineralized allograft with bone marrow aspirate or a combination thereof must be placed in the area to be fused and the graft must be in contact with viable bone.
  5. Internal and external threads on instruments can be damaged by cross-threading. Inspect internal and external threads for damage prior to assembly. If threads are damaged, set the product aside and do not use. When threading components together, keep to the thread axis. Screw in the component as far as it will go and make sure that the product is flush with the insertion instrument. On all threaded connections, finger tighten only.

Postoperative:

  1. The physician’s postoperative directions and warnings to the patient and corresponding patient compliance are extremely important.
  2. Detailed instructions on the use and limitations of the implant 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, or breakage of the implant are complications which can occur as a result of excessive or early weight bearing or excessive muscular activity. The risk of bending, loosening, or breakage of an internal fixation device during postoperative rehabilitation may be increased if the patient is active or if the patient is debilitated, demented, or otherwise unable to use crutches or other such weight supporting devices. The patient should be warned to avoid falls or sudden jolts in spinal position.
  3. To allow maximum chances for a successful surgical result, the patient should not be exposed to mechanical vibrations that may loosen the implant. The patient should be warned of this possibility and instructed to limit and restrict physical activities, especially lifting, twisting motions, and any type of sport participation. The patient should be advised not to smoke or consume alcohol during the bone graft healing process.
  4. The patient should be advised of their inability to bend at the point of spinal fusion and taught to compensate for this permanent physical restriction on body motion.
  5. If a nonunion develops or if the implant loosens, bends, and/or breaks, the implant should be revised and/or removed immediately before serious injury occurs. Failure to immobilize a delayed or nonunion of bone will result in excessive and repeated stresses on the implant. By the mechanism of fatigue, these stresses can cause eventual bending, loosening or breakage of the implant. It is important that immobilization of the spinal surgical site be maintained until firm bony union is established and confirmed by roentgenographic examination. The patient must be adequately warned of these hazards and closely supervised to insure cooperation until bony union is confirmed.
  6. Any retrieved implants should be treated in such a manner that reuse in another surgical procedure is not possible. As with all  orthopedic implants, none of the Endoskeleton TC Interbody Fusion implants should ever be reused under any circumstances. Reuse may result in, but is not limited to the following; infection or bending, loosening or breakage due  to impairment of implant integrity.

ADVERSE EVENTS

Possible adverse effects include, but are not limited to, bending, loosening, or fracture of the implants or instruments; loss of fixation; sensitivity to a metallic foreign body, including possible tumor formation; skin or muscle sensitivity in patients with inadequate tissue coverage over the operative site, which may result in skin breakdown and/or wound complications; nonunion or delayed union; infection; nerve or vascular damage due to surgical trauma, including loss of neurological function, dural tears, radiculopathy, paralysis, and cerebral fluid leakage; gastrointestinal, urological and/or reproductive system compromise, including sterility, impotency, and/or loss of consortium; pain or discomfort; bone loss due to resorption or stress shielding, or bone fracture at, above, or below the level of surgery (fracture of the vertebra); hemorrhage of blood vessels and/or hematomas; malalignment of anatomical structures, including loss of proper spine curvature, correction, reduction, and/or height; bursitis; bone graft donor site pain; inability to resume activities of normal daily living; reoperation or death.

ENDOSKELETON™ TCS INTERBODY FUSION DEVICE IMPLANTS

DESCRIPTION

The Endoskeleton TCS Interbody Fusion Device is available in a variety  of sizes and is designed with a large hollow region in the center to  house autograft bone, allograft bone comprised of cancellous and/or  corticocancellous bone, demineralized allograft with bone marrow aspirate, or a combination thereof. The design incorporates “windows” through the  implant to permit visualization of the graft material and over time formation  of new bone. The superior and inferior surfaces include either the Chemtex™  surface  treatment or nanoLOCK surface treatment (MMN) designed to improve fixation to the adjacent bone. The nanoLOCK surface technology (MMN) provides a microscopic roughened surface with nano-scale  features. The new bone formation through the implant is intended to  provide long-term structural support and fusion at the implanted disc  space. The Endoskeleton TCS Interbody Fusion  Device system includes integrated fixation screws for stabilizing the implants when placed in the interbody space. The implants and screws are composed of ASTM F136  Ti 6Al-4V ELI titanium alloy and are provided either sterile or non-sterile.

An implant holding feature has been incorporated into the trailing surface of the implant to mate with the implant inserter, and to facilitate placement of the implant into the interbody space. Screws  include internal hexalobular drive features matched to instrumentation for installation.

INDICATIONS FOR USE

The Endoskeleton TCS Interbody Fusion Device is an anterior cervical  intervertebral body fusion device indicated for use in skeletally mature patients with degenerative disc  disease (DDD) (defined as pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) at one disc level from C2 to T1. Patients should have received 6 weeks  of non-operative treatment prior to treatment with the device.  The device is indicated to be used with autograft bone and/or allograft  bone comprised of cancellous and/or corticocancellous bone and/or  demineralized allograft bone with bone marrow aspirate. The  device is a stand-alone system when used with Endoskeleton TCS Interbody Fusion Device integrated screws and when used without the integrated screws it requires additional supplemental  fixation cleared for the cervical spine.

WARNINGS

In using metallic implants, the surgeon should be aware of the following:

  1. The 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.
  2. The surgeon must ensure that all necessary implants and instruments are on hand prior to surgery. An adequate inventory of implant sizes should be available at the time of surgery, including sizes  larger and  smaller than those expected to be used.
  3. The correct handling of the implants is extremely important. Contouring of the implants is to be avoided.
  4. The Titan Spine Endoskeleton TCS Interbody Fusion Device has not  been evaluated for safety and compatibility in the MR environment.  It has not been tested for heating, migration, or image  artifact in the  MR environment. The safety of Endoskeleton TCS Interbody Fusion  Device in the MR environment is unknown. Scanning a patient who has this device may result in patient injury.

CONTRAINDICATIONS

  1. As with all orthopedic implants, the Endoskeleton TCS Interbody Fusion Device should never be reused under any circumstances. Reuse may result in but is not limited to the following;  infection or bending, loosening or breakage due to impairment of implant integrity.
  2. The Endoskeleton TCS Interbody Fusion Device should never be  implanted in patients with a systemic or local infection.
  3. The Endoskeleton TCS Interbody Fusion Device should not be used  with components of any other interbody systems.
  4. The Endoskeleton TCS Interbody Fusion device should not be implanted in patients with an allergy to titanium or titanium alloys. 
  5. All patients should have at least 6 weeks of non-operative care prior to spinal fusion with the Endoskeleton TCS Interbody Fusion device. 
  6. The Endoskeleton TCS Interbody Fusion Device should not be implanted in patients with a prior fusion at the level(s) to be treated.

PRECAUTIONS

Preoperative:

  1.  Only patients that meet the criteria described in the indications should be selected.
  2. Based on fatigue testing results, when using the Endoskeleton TCS Interbody Fusion Device, the physician/surgeon should consider the levels of implantation, patient weight, patient activity  level, other patient conditions, etc., which may impact on the performance of this system.
  3. Safety and effectiveness  has not been established  in patients  with  the following conditions:  morbid obesity;  symptomatic cardiac  disease;  pregnancy; signs of local inflammation;  fever or leukocytosis; metal sensitivity/allergy to the implant materials; any medical or surgical condition which would preclude the potential benefit of spinal implant surgery, such as the elevation  of sedimentation rate unexplained by other diseases, elevation of white blood count (WBC), or a marked left shift in the WBC differential count; grossly distorted anatomy due to congenital  abnormalities; osteopenia, and/or osteoporosis (osteoporosis is a relative contraindication since this condition may limit the obtainable correction, the amount of mechanical fixation, and/or the  quality of the bone graft); long term systemic corticosteroid use; active drug abuse; any case requiring the mixing of metals from different components; any patient having inadequate tissue coverage  over the operative site or where there is inadequate bone stock, bone quality, or anatomical definition; any patient unwilling to cooperate with the postoperative instructions; any time implant  utilization would interfere with  anatomical structures or expected physiological performance. Patient conditions and/or predispositions such as these should be avoided. Other conditions may exist  where safety and effectiveness have not been established.
  4. Care should be used in handling and storage of the implants and instruments. The implants should not be scratched or otherwise damaged. Implants and instruments should be protected during storage especially from corrosive environments. Devices should be routinely inspected; if they exhibit wear, damage, corrosion, or discoloration they should be returned to Titan Spine for further  evaluation.
  5. The type of construct to be assembled for the case should be determined prior to beginning the surgery.
  6. Because mechanical parts are involved, the surgeon should be familiar with the various components before using the equipment and should personally assemble the implants to verify that all parts  and necessary instruments are present before the surgery begins.
  7. Proper implant selection and patient compliance to postoperative precautions will greatly affect surgical outcomes. Patients who smoke have been shown to have an increased incidence of  nonunion. Therefore, these patients should be advised of this  fact and warned of the potential consequences.
  8. Postoperative care is important. The patient should be instructed in the limitations of his/her metallic implant(s) and should be  cautioned regarding weight bearing and body stress on the  appliance  prior to secure bone healing.

Intraoperative:

  1. Any instruction manuals should be carefully followed.
  2. At all times, extreme caution should be used around the spinal cord and nerve roots. Damage to nerves may occur resulting in loss of neurological functions.
  3. The implant surfaces should not be scratched or notched since such actions may reduce the functional strength of the construct.
  4. Either autograft, cancellous and/or corticocancellous allograft, demineralized allograft with bone marrow aspirate or a combination thereof must be placed in the area to be fused and the graft must be in contact with viable bone.
  5. Internal and external threads on instruments can be damaged by cross-threading. Inspect internal and external threads for damage prior to assembly. If threads are damaged, set the product aside  and do not use. When threading components together, keep to  the thread axis. Screw in the component as far as it will go and  make sure that the product is flush with the insertion instrument. On  all threaded connections, finger tighten only.

Postoperative:

  1. The  physician’s postoperative  directions and warnings to  the patient and  corresponding patient compliance  are extremely important.
  2. Detailed instructions on the use and limitations of the implant(s) 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 or breakage of the  implant(s) are complications which can occur as a result of excessive or early weight bearing or excessive muscular activity. The risk of bending,  loosening or breakage of an internal fixation device during postoperative rehabilitation may be increased if the patient is active or if the patient is debilitated, demented or otherwise unable to use  crutches or other such weight supporting devices. The patient should be warned to avoid falls or sudden jolts in spinal position.
  3. To allow maximum  chances for a successful surgical result,  the patient of implant(s) should not be  exposed  to mechanical vibrations that may loosen the implant(s). The  patient should be  warned  of this possibility and instructed to limit and restrict physical activities, especially lifting, twisting motions and any type of sport participation. The patient should be advised not to smoke or  consume  alcohol during the bone graft healing process.
  4. The patient should be  advised of their inability to bend  at the point of spinal fusion and taught to compensate  for this permanent  physical restriction on  body motion.
  5. If a nonunion develops or if the implant(s) loosen, bend and/or break, the implant(s) should be revised and/or removed immediately before serious injury occurs. Failure to immobilize a delayed or nonunion of bone will result in excessive and repeated stresses  on the implant(s). By the mechanism of fatigue these stresses can cause eventual bending, loosening or breakage of the implant(s).  It is important that immobilization of the spinal surgical site be  maintained until firm bony union is established and confirmed by roentgenographic examination. The patient must be adequately  warned of these hazards and closely supervised to ensure  cooperation until bony union is confirmed.
  6. Any retrieved implants should be treated in such a manner that reuse in another surgical procedure is not possible. As with all  orthopedic implants, none of the Endoskeleton TCS Interbody  Fusion Devices should ever be reused under any circumstances. Reuse may result in but is not limited to the following; infection or  bending, loosening or breakage due to impairment of  implant integrity.

ADVERSE EVENTS

Possible adverse effects include, but are not limited to, bending,  loosening, or fracture of the implants or instruments; loss of  fixation; sensitivity to a metallic foreign body, including  possible tumor formation; skin or muscle sensitivity in patients with inadequate tissue coverage over the operative site, which may result in skin breakdown and/or wound complications; nonunion  or delayed union; infection; nerve or vascular damage due to surgical trauma, including loss of neurological function, dural tears, radiculopathy, paralysis, and cerebral fluid leakage; gastrointestinal,  urological and/or reproductive system compromise, including sterility, impotency, and/or loss of consortium; pain or discomfort; bone loss due to resorption or stress shielding, or bone fracture at,  above, or below the level of surgery (fracture of the vertebra); hemorrhage of blood vessels and/or hematomas; malalignment of anatomical structures, including loss of proper spine curvature,  correction, reduction, and/or height; bursitis; bone graft donor site pain; inability to resume activities of normal daily living; reoperation or death.