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
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®
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
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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.
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P/N 5054-01 E
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