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