Timberline^® Lateral Fusion System

Description

The Timberline device is an intervertebral body fusion/vertebral body replacement device generally consisting of a rectangular shape with various lengths, widths, heights, and lordotic angles which may incorporate a measuring function and has uses as described on the label. The device has a hollowed out central area to accommodate autogenous bone graft. The upper and lower surfaces have a series of transverse grooves formed to improve stability and fixation once the device is inserted. The Timberline device is available in a variety of sizes and configurations to approximate anatomical variation in different vertebral levels and/or patient anatomy. The Timberline system includes disc prep and general instruments, a retractor system, and several disposables. The Timberline instrument set consists of a comprehensive set of instrumentation to perform the surgery. The retractor system consists of three blades with an optional fourth blade attachment. The posterior blade moves independently with respect of the cranial-caudal blades. Multiple blade lengths are available. Other features include toeing blades up to 20°, controlled opening/closing of the arms with infinite resolution, intra-discal docking shims, blade widening and lengthening shims and superior lighting. Zimmer Biomet Spine provides a disposable kit which is used for accessing the disc space and for neuromonitoring if elected by the surgeon.

The Timberline MPF device is an intervertebral body fusion device consisting of a PEEK-OPTIMA® polymer intervertebral spacer, titanium plate, and screws. The interbody spacer has a generally rounded shape with various heights and footprints and has a hollowed out central area to accommodate autogenous bone graft. The upper and lower surfaces have a series of transverse grooves formed to improve stability and fixation once the device is inserted. The titanium plate has holes for receiving bone screws and a central hole for receiving a cover plate to prevent screw back-out. The Timberline MPF system is available in a variety of sizes and configurations to approximate anatomical variation in different vertebral levels and/or patient anatomy. The Timberline MPF system is provided non-sterile.

Indications

When used as a lumbar intervertebral body fusion device, the Timberline system is intended for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These DDD patients may have had a previous non-fusion spinal surgery at the involved spinal level(s), and may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The Timberline system is to be combined with supplemental fixation. Approved supplemental fixation systems include the Zimmer Biomet Spine Spinal Fixation System. The following devices are indicated to be used as a lumbar intervertebral body fusion device:

Table 1: Timberline Lateral Fusion System PEEK implants cleared for lumbar intervertebral body fusion

When used as a vertebral body replacement, the Timberline system is indicated for use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use as a vertebral body replacement in the thoracolumbar spine (from T1 to L5). The Timberline system may also be used in the thoracolumbar spine (i.e.T1- L5) for partial replacement (i.e. partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Timberline device is also indicated for treating fractures of the thoracic and lumbar spine. The Timberline system is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column. For either indication the system must be used with supplemental internal fixation. Supplemental internal fixation is required to properly utilize this system.

The following devices are indicated to be used as a vertebral body replacement (VBR) device:

Table 2: Timberline Lateral Fusion System PEEK implants cleared for Vertebral Body Replacement (VBR)

When used as a lumbar intervertebral body fusion device, the Timberline MPF System is intended for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients with degenerative disc disease (“DDD”) at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These DDD patients may have had a previous non-fusion spinal surgery at the involved spinal level(s), and may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). Implants with 20 degree lordosis or greater are only indicated from levels L2-L5 and are to be used with at least one integrated fixation screw. The Timberline MPF implants are to be used with supplemental fixation. Approved supplemental fixation systems include the Zimmer Biomet Spinal Fixation System.

Contraindications

Contraindications for the Timberline system include, but are not limited to:

• Presence of fever or infection (systemic, spinal, or localized).
• Pregnancy.
• Severe osteopenia.
• Prior fusion at the level to be treated.
• Any condition not described in the Indications of Use.

Any other medical or surgical condition which would preclude the potential benefit of spinal implant surgery, patients with metal sensitivity or allergies to the implant materials, and patients unwilling or unable to cooperate with postoperative care instructions.

Contraindications may be relative or absolute. The choice of a particular device must be carefully weighed against the patient’s overall evaluation. Circumstances listed below may reduce the chance of a successful outcome. Contraindications for the Timberline MPF system include, but are not limited to:

• Allergy to PEEK, titanium or cobalt chrome alloys, or foreign body sensitivity. Where material sensitivity is suspected, appropriate tests should be made prior to implantation.
• Known or suspected infection/immune system incompetence. Acute or chronic infectious diseases of any etiology or localization.
• Any abnormality present which affects the normal process of bone remodeling including, but not limited to, severe osteoporosis involving the spine, bone absorption, osteopenia, active infection at the site or certain metabolic disorders affecting osteogenesis.
• Morbid Obesity. An overweight or obese patient can produce loads on the spinal system, which can lead to failure of the fixation of the device or failure of the device itself.
• Any neuromuscular deficit which places an unusually heavy load on the device during the healing period.
• Open Wounds.
• Pregnancy.
• Any other medical or surgical condition which would preclude the potential benefit of spinal surgery, such as the presence of congenital abnormalities, elevation of sedimentation rate unexplained by other diseases, elevation of the white blood count (WBC), or a marked left shift in the WBC differential count.
• Any case requiring the mixing of components from two different systems.
• Any case requiring the mixture of stainless steel with titanium, or stainless steel with cobalt chrome implant components.
• Fever or leukocytosis.
• Signs of local infection or inflammation.
• Previous history of infection.
• Prior fusion at the level to be treated.
• Alcoholism or heavy smoking.
• Senility, mental illness or substance abuse, of a severity that the patient may ignore certain necessary limitations and precautions in the use of the implant, leading to failure or other complications.
• Any patient unwilling to follow postoperative instructions.
• Inadequate tissue coverage over the operative site.

Possible Complications

• Possible complications specific to the device may include:
• Early or late implant bending, breakage, failure, loosening or movement/migration
• Bone fracture
• Allergic reaction to implant material
• Other general complications associated with any spinal surgical procedure may include: Non-union or delayed union, pseudoarthrosis; pain; second surgery; bleeding; infection, early and late; tissue or nerve damage, including dural tears or other neurological problems; incisional complications; scar formation; damage to blood vessels and cardiovascular system compromise; changes in mental status; damage to internal organs and connective tissue; complications due to the use of bone grafting, including graft donor site complications; respiratory problems; reactions to anesthesia and/or death.

Warnings

For the Timberline System and the Timberline MPF System:

Patients with previous spinal surgery at the levels to be treated may have different clinical outcomes compared to those with no previous surgery. The risk of a device expulsion and migration is higher without the use of supplemental fixation.

Precautions

The Timberline System:

Only experienced spinal surgeons should perform the implantation of this system with specific training in the use of vertebral implants. The surgical procedure is technically demanding and presents a risk of serious injury to the patient. The Timberline device is intended to be used only by surgeons specialized in spinal surgery and having thorough knowledge of vertebral anatomy, regional vertebral morphology, and the biomechanical principles of the spine. It is advised that the surgeon also be thoroughly familiar with the surgical techniques relative to the use of the device. Risks associated with neurosurgery, general surgery, orthopedic surgery, and the use of general anesthesia should be explained to the patient prior to surgery. It is recommended that the advantages and disadvantages of using implants, as well as alternative treatment methods, are explained to the patient. If neuromonitoring is selected for use by the surgeon, inform the anesthesiologist that EMG monitoring will be used during the procedure to ensure that no neuromuscular blocking agents are administered during monitoring. A fastacting neuromuscular agent should be used during intubation. Correct selection and placement of the implants is extremely important. Implant selection must be based upon the bone defect to be treated as well as the patient’s weight, height, occupation, or degree of physical activity. Proper handling of the implant before and during the operation is crucial. The Timberline device must only be used with appropriate secondary stabilization instrumentation. The Timberline device must not be used with vertebral components or instruments from other manufacturers. Before use, inspect all instrumentation for possible damage, wear, or non-function. Damaged or defective instruments should not be used or processed. Contact your local Zimmer Biomet Spine representative or dealer for repair or replacement. The use of an instrument for tasks other than those for which they are indicated may result in damaged or broken instruments. Do not apply excessive force or stress. Misuse can damage instruments or implants. Perform a careful preoperative review to be sure that all necessary implant components are available and that the instrument set is complete and in working order prior to initiating surgery. The instrument and implant components of the Timberline system should NOT be used with the instrument components from any other system or manufacturer. The Timberline lateral fusion device has not been tested for safety and compatibility in the magnetic resonance (MR) environment. The Timberline device has not been tested for heating or migration in the MR environment. The Timberline lateral fusion device is for single use only. Reuse of the implant components may result in reduced mechanical performance, malfunction, or failure of the device.

The Timberline MPF System:

The Timberline MPF implants are for single use only. Never reuse any implant even if it appears unmarked or undamaged. Reuse of the implant components may result in reduced mechanical performance, malfunction, or failure of the device. Any implant implanted and then removed must be discarded. Use only new implants for each case. Only experienced spinal surgeons should perform the implantation of this system with specific training in the use of vertebral implants. The surgical procedure is technically demanding and presents a risk of serious injury to the patient. The Timberline MPF system is intended to be used only by surgeons specialized in spinal surgery and having thorough knowledge of vertebral anatomy, regional vertebral morphology, and the biomechanical principles of the spine. It is advised that the surgeon also be thoroughly familiar with the surgical techniques relative to the use of the device.

Based on the fatigue testing results, the physician/surgeon must consider the levels of implantation, patient weight, patient activity level, other patient conditions, etc. which may impact on the performance of the system. Risks associated with neurosurgery, general surgery, orthopedic surgery, and the use of general anesthesia should be explained to the patient prior to surgery. It is recommended that the advantages and disadvantages of using implants, as well as alternative treatment methods, are explained to the patient. Preoperatively: The surgeon must be fully conversant with all aspects of the surgical technique and know the indications and contra-indications of this type of implant. The surgeon must have acquainted himself before the operation with the specific technique for insertion of the product, which is available from the manufacturer. As part of the preoperative examination, the surgeon must check that no biological, biomechanical or other factors will affect the correct conduct of the operation and the postoperative period. An appropriate range of implant sizes must be available at the time of the operation. Intraoperatively: The correct selection of the type and size of implant appropriate to the patient and the positioning of the implant are extremely important. Postoperatively: Patients must be informed of the precautions to be taken in their everyday life to guarantee a maximum implant service life. It is recommended that regular postoperative follow-up is undertaken to detect early signs of failure of the implants and to consider the action to be taken. Deterioration of the device after bone consolidation cannot be considered to constitute a dysfunction or deterioration in the characteristics of the implants. The use of guides is required to help ensure appropriate screw trajectory. Correct selection and placement of the implants is extremely important. Implant selection must be based upon the bone defect to be treated as well as the patient’s weight, height, occupation, or degree of physical activity. When using the soft tissue retractor, care must be taken to ensure it is correctly and safely placed. Proper handling of the implant before and during the operation is crucial. Use of the cover plate to prevent back-out of the screws is mandatory. Use of the integrated screws with lordotic angles of 20 degrees and above is mandatory. If a cover plate is disassembled from a plate, it must be discarded and not reused. If a plate is disassembled from an interbody spacer, it must be discarded and not reused. The Timberline MPF device must not be used with vertebral components or instruments from other manufacturers. Before use, inspect all instrumentation for possible damage, wear, or non-function. Damaged or defective instruments should not be used or processed. Contact your local Zimmer Biomet Spine representative or distributor for repair or replacement. The use of an instrument for tasks other than those for which they are indicated may result in damaged or broken instruments. Do not apply excessive force or stress. Misuse can damage instruments or implants. Perform a careful preoperative review to be sure that all necessary implant components are available and that the instrument set is complete and in working order prior to initiating surgery. The Timberline MPF system has not been tested for safety and compatibility in the magnetic resonance (MR) environment. The Timberline MPF system has not been tested for heating or migration in the MR environment. Mixing of dissimilar metals can accelerate or initiate the corrosion process. Titanium components must NOT be used together in building a construct that involves other implant materials. Titanium and cobalt chrome may be used together within the same construct.