CoAlign® Innovations AccuLIF® TL Cage
INSTRUCTIONS FOR USE
MANUFACTURED BY:
CoAlign Innovations, Inc.
150 North Hill Drive
Suite 1
Brisbane, CA 94005
USA
Caution:Federal(USA)lawrestrictsthedevicetosale,
distributionandusebyorontheorderofaphysician.
Deviceisforsingle‐useonly.
P/N 5054-01 E
Page1
®
AccuLIF
TL Interbody Fusion Cage
DEVICE DESCRIPTION:
The CoAlign Innovations AccuLIF® TL device is an expandable interbody fusion cage.
The device is inserted in its unexpanded state with an articulating delivery handle. Then
it is expanded in-situ to the required height via a 2 hydraulic cylinder and piston
arrangement using a hydraulic system comprised of a disposable flexible expansion
tubing set and inflation syringe. The device locks in 1mm increments as it expands.
The AccuLIF TL device comes in three sizes which are expandable from 6mm to 9mm,
from 8mm to 12mm, and from 10mm to 16mm in 1mm increments. Each size comes in
two different footprints 11mm x 34mm and 13mm x 34mm for a total of 6 models. The
device has fixation ridges on the top and bottom surfaces. It also has a graft window
opening which extends from the bottom surface to the top surface. The device has a
proximal boss which has a threaded connection port for connecting to the inserter and a
fluid port for transporting the expansion fluid.
DEVICE MATERIALS:
The AccuLIF TL device is comprised of the following materials:
Titanium Alloy (Ti6Al4V)
Stainless Steel (316 LVM)
Silicone Rubber
P/N 5054-01 E
Page2
INDICATIONS FOR USE:
The CoAlign Innovations AccuLIF TL Cage is intended for intervertebral body fusion
with autogenous bone graft material in patients with degenerative disc disease (DDD) at
one level or two contiguous levels from L2 to S1. DDD is defined as back pain of
discogenic origin with degeneration of the disc confirmed by history and radiographic
studies. These DDD patients may also have up to Grade I spondylolisthesis or
retrolisthesis at the involved level(s). The patient should be skeletally mature and have
completed a minimum of six months of non-operative treatment.
The AccuLIF TL cage is to be use with supplemental fixation. Additionally, the CoAlign
Innovations AccuLIF TL Cage is to be used with autogenous bone graft.
CONTRAINDICATIONS:
The AccuLIF TL device is contraindicated in patients with:
• An allergy to titanium or titanium alloy
• Gross spinal anatomy or disease that would prevent implantation of the device or
cause the device to be unstable in situ
• Significant instability of the lumbar spine, e.g., isthmic spondylolisthesis or
degenerative spondylolisthesis greater than grade 1.0 (on a scale of 1 to 4)
• Diagnosis of severe osteoporosis, defined as bone mineral density (from DEXA
scan or equivalent method) in the spine or hip that is more than 2.5 S.D. below
the mean of adult normal population
• Active systemic infection, or infection localized to the site of implantation
• Morbid obesity
• Pregnancy
• Any medical or physical condition which would preclude potential benefit of spinal
implant surgery
• Prior fusion at the level(s) to be treated
• Any condition not described in the indications for use
CAUTION:
The AccuLIF TL Cage is manufactured from titanium alloy and stainless steel, which are
known to produce MRI artifacts. The AccuLIF TL Cage has not been evaluated for
safety and compatibility in the MR environment. The AccuLIF TL Cage has not been
tested for heating or migration in the MR environment.
Page3
P/N 5054-01 E
Patients should be warned to disclose the presence of the AccuLIF TL Cage prior to an
MRI exam. Failure to do so may affect the quality of diagnostic information obtained
from the scans.
PRECAUTIONS:
• The implantation of the AccuLIF TL device should be performed only by qualified
and experienced spinal surgeons having specific training in the implantation of
the device, as this is a technically demanding procedure presenting risk of
serious injury to the patient.
• Surgeons should not implant the AccuLIF TL until receiving adequate training in
surgical technique. Inadequate training may result in poor patient outcomes
and/or increased rates of adverse events.
• Based on the fatigue testing results, as with other spinal devices, when using the
AccuLIF TL Cage, the surgeon should consider the levels of implantation, patient
weight, patient activity level, other patient conditions, etc. which may impact on
the performance of the system.
• Patients with previous spinal surgery at the level(s) to be treated may have
different clinical outcomes compared to those without a previous surgery.
• Use only the pressure necessary to expand the AccuLIF TL Cage to the height
required to achieve a tight fit in the intervertebral space. Use of additional
pressure beyond what is required to achieve a tight fit may cause damage to
remaining anatomy such as the vertebral endplates.
• Dissimilar metals in contact with each other can accelerate the corrosion process
due to galvanic corrosion effects. Do not use implants or instruments from other
systems or manufacturers, and do not mix stainless steel and titanium implant
components together in the same spinal construct. The components of the
AccuLIF TL system should not be used with the components of any other system
or manufacturer.
POTENTIAL COMPLICATIONS AND ADVERSE EFFECTS:
The potential complications and adverse effects with the implantation of AccuLIF TL are
similar to other spinal instrumentation.
• AccuLIF Device Related:
- Device breakage, dislodgement or migration
- Additional surgery, which could include removal of the implant
- Foreign body reaction
P/N 5054-01 E
Page4
- Mechanical failure of the implant
- Failure of the device/procedure to improve symptoms and/or function
- Non-union (pseudarthrosis), delayed union or mal-union
• Surgery Related:
- Reaction to anesthesia
- Myocardial infarction
- Infection
- Blood vessel damage/bleeding
- Deep vein thrombosis
- Hematoma
- Pneumonia
- Neurological system compromise
- Stroke
- Nerve injury or spinal cord damage
- Paralysis
- Thrombus formation
- Wound dehiscence or delayed healing
- Pain/discomfort at the operative site
- Death
IMPLANT PACKAGING:
The AccuLIF TL implants are provided individually packaged and provided sterile.
Implants are packaged on a plastic card which is sealed inside 2 tyvek pouches which
in turn is enclosed in a chipboard box. Open both pouches and transfer the implant and
card from the inner pouch into the sterile field using sterile technique. Damaged
products should not be used and should be returned to CoAlign.
P/N 5054-01 E
Page5
A non-sterile instrument kit comprising insertion handle, pressure syringe, slap hammer,
graft block, nut tightener, and graft insertion tools is also required to insert the implants.
The unlock tubing set is supplied sterile and sealed inside 2 tyvek pouches which in turn
is enclosed in a chipboard box. Open both pouches and transfer the tubing set from the
inner pouch into the sterile field using sterile technique. See Surgical Technique
Page6
P/N 5054-01 E
Guide for assembling the implant, inserter, syringe and the flexible tubing. Details for
expanding the implant to the desired height are described in the Surgical Technique
Guide which can be obtained by contacting the company representative.
A non-sterile set of distractor trials is also provided to aid in selection and insertion of
the implants.
P/N 5054-01 E
Page7
IMPLANT AND INSTRUMENT KIT CLEANING,
DECONTAMINATION AND STERILIZATION:
The AccuLIF insertion instruments and distractor trial instruments are supplied non
sterile and must be properly sterilized before use.
Steam Sterilization Parameters:
Wrap the instrument trays separately in two layers of FDA approved 1-ply
polypropylene wrap using a sequential wrapping technique.
Use a pre-vacuum type sterilizer
Three preconditioning pulses
Minimum 132 °C (270 °F) for 4 minutes
Minimum of 30 minutes of dry time
The AccuLIF instrument set and distractor trial set are both reusable for up to 20 uses
and must be cleaned after use.
AccuLIF Instrument and Distractor Trial Cleaning Parameters:
Immerse each instrument in an enzymatic detergent and allow it to soak for a
minimum of 5 minutes. Articulate the instrument while soaking to ensure all
surfaces are reached.
Use a soft bristled brush to scrub the entire surface of each instrument paying
close attention to hard to reach areas. A syringe and pipe cleaner may be used
to clean cracks, crevices and other hard to reach areas. Articulate the
instrument while cleaning to ensure all surfaces are reached. Change the
detergent if it becomes gross or turbid.
Immerse each instrument in fresh enzymatic solution and sonicate for a minimum
of 20 minutes. Articulate the instrument while soaking to ensure all surfaces are
reached.
Immerse each instrument in fresh enzymatic solution and again allow it to soak
for a minimum of 5 minutes. Articulate the instrument while soaking to ensure all
surfaces are reached.
Use a soft bristled brush to scrub the entire surface of each instrument paying
close attention to hard to reach areas. A syringe and pipe cleaner may be used
to clean cracks, crevices and other hard to reach areas. Articulate the
instrument while cleaning to ensure all surfaces are reached.
P/N 5054-01 E
Page8
Immerse each instrument in fresh enzymatic solution and again sonicate for a
minimum of 20 minutes. Articulate the instrument while soaking to ensure all
surfaces are reached.
Remove each instrument from the detergent and rinse under running reverse
osmosis/de-ionized (RO/DI) water to remove any residual detergent. A syringe
maybe used to aid in the rinsing.
Visually inspect all surfaces of each instrument to ensure that it is thoroughly
cleaned and that no contamination remains. If any contamination is noted repeat
all of the above steps and re-inspect the instrument until no contamination is
seen.
After cleaning the instruments, they can be placed in the instrument tray or
distractor trial tray as appropriate and resterilized following the above procedure
prior to reuse.
STORAGE:
The AccuLIF insertion instruments and distractor trials must be stored in the instrument
tray in a clean area until ready for use.
INSTRUCTION FOR USE:
The surgeon implanting the AccuLIF TL is expected to be fully educated and trained in
the techniques necessary to implant the device.
Please refer to the AccuLIF TL Surgical Technique Guide for recommended
implantation procedures.
The techniques for implanting the AccuLIF TL should be reviewed by the surgeon prior
to use of the system.
Proper selection of patients and good compliance of patients with instructions for
postoperative care and behavior are critical to the realization of a successful procedure.
All patients contemplating implantation of this device should be apprised of the risks
associated with the procedure, as well as the limitation of activities the patient will face
following surgery. The surgeon is expected to provide detailed instructions to the patient
regarding postoperative activities.
The surgeon should inspect the implants and instruments of the AccuLIF TL before
surgery to assure that all necessary components are present. The surgeon must inspect
the instruments to assure that they are properly functioning and to check for
deterioration such as corrosion, pitting, or cracks. Any instrument that is found with
deterioration should not be used. Discard any deteriorated instruments and contact
your company representative for a replacement.
A successful result may not occur in every case in which an AccuLIF TL is implanted.
See the Complication and Adverse Effects in this document.
Page9
P/N 5054-01 E
REVISIONHISTORY
Revision
Level
A 1/17/12 239 J. Ashley Initial release.
B 2/16/12 250 H.
C 7/17/12 360 J. Ashley Added Distractor Trial information.
D 7/18/12 363 J. Ashley Rolled to new Rev for MDT - no change
E 8/30/12 401 J. Ashley Updated Tubing Set and Distractor Trial
Effective
Date
ECO
Number
Document
Originator
Bauguess
Change Details
Change Company and product logos to ®
rather than ™, Removed symbols and
replaced with written designation,
corrected typos
to document.
Figures.
NOTE: DO NOT INCLUDE THIS LAST PAGE IN PRINTED PRODUCT INSERT
P/N 5054-01 E
Page10
Loading...