MIS Fusion

TIMBERLINE™ Lateral Fusion System

Important Safety Information

Purpose
The Biomet Spine® Fusion System – Lateral (also known as Timberline™ Lateral Fusion System) represents a complete and comprehensive minimally invasive lateral intervertebral body fusion/vertebral body replacement system consisting of implants and instruments for the treatment of degenerative lumbar conditions.

Device 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 accomodate 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. Biomet Spine provides a disposable kit which is used for accessing the disc space and for neuromonitoring if elected by the surgeon.

Materials
The Timberline implant is made of PEEK-OPTIMA® TL1 polymer material. PEEK-OPTIMA LT1 polymer is a polyaromatic semicrystalline thermoplastic, and meets the requirements of ASTM F-2026 and ISO 10993. Chemically the material has the following basic formula, (-C6H4-O-C6H4-O-C6H4-CO-)n, and is known generically as polyetheretherketone (PEEK). All PEEK implants are made from this implant grade material with tantalum position markers meeting the requirements of ASTM F560. The PEEK device is radiolucent. The Timberline system is provided non-sterile except for a few disposable devices which are provided sterile.

Indications
When used as a lumbar intervertebral body fusion device, the Biomet Spine 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 Biomet Spine Spinal Fixation System.

The following devices are indicated to be used as a lumbar intervertebral body fusion device:

Table 1:
Biomet Spine® Timberline™ Lateral Fusion System PEEK implants
cleared for lumbar intervertebral body fusion

Description Length Range Width Range Height Range Lordotic Angles
Timberline 25 to60mm 16, 18, 22, 26mm 6 to16mm 0° and8°

 

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:
Biomet Spine® Timberline™Lateral Fusion System PEEK implants
cleared for Vertebral Body Replacement (VBR)

Description Length Range Width Range Height Range Lordotic Angles
Timberline 25 to 60mm 16, 18, 22, 26mm 6 to 50mm 0° and 8°

 

Contraindications
Contraindications 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.

Risks
Potential risks identified with the use of this device system, which may require additional surgery include: device component failure (expulsion, loosening or breakage of the implant). Failure may occur as a result of implant stress, loss of fixation, non-union, infection, or subsequent fracture of the vertebra. Implant failure may result in neurological injury and vascular or visceral injury. These devices can break when subjected to increased loading associated with delayed union or non-union. Internal fixation appliances are load-sharing devices, which hold a fracture in alignment until healing occurs.

If healing is delayed or does not occur, the implant could eventually break due to material fatigue. The patient's weight, activity level, and compliance to weight bearing or activity restrictions can have an effect on the stresses to which the implant is subjected. Such stresses may affect the long term survival of the implant. The following warnings do not include all possible adverse effects, but are important considerations particular to spinal fixation devices.

Warnings
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

  • 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 fast-acting 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 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 evaluated 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.
  • Federal Law (USA) restricts this device to sale by or on the order of a licensed physician only.