Johnson & Johnson DePuy Synthes Kaneda User manual

KANEDA™Anterior Scoliosis System
KANEDA™SR Anterior Spinal System
M-2®Anterior Plate System
UNIVERSITY PLATE®Anterior System
FRONTIER®Anterior Scoliosis System
PROFILE®Anterior Thoracolumbar
Plate System
AEGIS®Anterior Lumbar Plate System
BOWTI®Anterior Buttress Staple
Spinal System
EXPEDIUM®Anterior Spine System
150-050
Rev. N
Revised July 2015
© DePuy Synthes Spine, a division of DOI 2013-2015.
All rights reserved.
0086

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IMPORTANT NOTE TO
OPERATING SURGEON
DePuy Spine anterior spinal system implants, like any other temporary
internal fixation devices, have a finite useful life. The patient’s activity
level has a significant impact on this useful life. Your patient must be
informed that any activity increases the risk of loosening, bending,
or breaking of the implant components. It is essential to instruct
patients about restrictions on their activities in the postoperative
period and to examine the patient postoperatively to evaluate the
development of the fusion mass and the status of the implant com-
ponents. Even if solid bone fusion occurs, implant components may
nevertheless bend, break, or loosen. Therefore, the patient must be
made aware that implant components may bend, break, or loosen
even though restrictions in activity are followed.
Because of the limitations imposed by anatomic considerations and
modern surgical materials, metallic implants cannot be made to last
indefinitely. Their purpose is to provide temporary internal support
while the fusion mass is consolidating. These implants are more
likely to fail if no bone graft is used or if a pseudarthrosis develops
or in patients with severe or multiple preoperative curves.
The surgeon may elect to remove these implants after bone fusion
occurs. The possibility of a second surgical procedure must be
discussed with the patient, and the risks associated with a second
surgical procedure must also be discussed. If the implants do
break, the decision to remove them must be made by the physician
considering the condition of the patient and the risks associated with
the presence of the broken implant.
USAGE
CAUTION: USA Law restricts these devices to sale by or on the
order of a physician.
The surgeon must be thoroughly knowledgeable not only in the
medical and surgical aspects of surgical implants, but must also be
aware of the mechanical and metallurgical limitations of metallic sur-
gical implants. See the surgical technique manuals for each Anterior
Spinal System for important instructions.
After solid fusion occurs, these devices serve no functional purpose
and may be removed. In most cases, removal is indicated because
the implants are not intended to transfer or support forces developed
during normal activities. Any decision to remove the device must
be made by the physician and the patient taking into consideration
the patient’s general medical condition and the potential risk to the
patient of a second surgical procedure.
WARNING: These Anterior Spinal device systems are not approved
for screw attachment or fixation to the posterior elements (pedicles)
of the cervical, thoracic, or lumbar spine.
DePuy Spine spinal system components should not be used with
components of spinal systems from other manufacturers.
DESCRIPTIONS
KANEDA Anterior Scoliosis System
The KANEDA Anterior Scoliosis System is a construct that consists
of KASS spinal staples, KASS blunt tip open and closed screws,
standard ISOLA open and closed screws and ISOLA 3/16 inch
(4.75 mm) diameter spinal rods. The components of the KANEDA
Anterior Scoliosis System are designed with anatomic limitations in
mind therefore minimizing the profile of the construct.
The KANEDA Anterior Scoliosis System is intended for anterolateral
screw fixation to the T4 to L4 levels of the spine, with all metal at
least 1 cm from a major vessel.
Spinal Staple: The KASS spinal staple is available in a single or
two-hole design.
The single-hole spinal staple is intended to be utilized in the thoracic
spine when the anatomy of the spine restricts the use of a two-holed
spinal staple. The single-hole spinal staple contains a centered
single machined hole designed to accommodate a 6.25mm diameter
open or closed screw. The single-hole spinal staple is contoured in
two planes. The single-hole spinal staple is available in one size.
The two-hole spinal staple contains two machined holes placed
diagonally across from one another. Both holes are designed to
accommodate a 6.25mm diameter open or closed screw. The two-
hole spinal staple is contoured in one plane which complements the
vertebral anatomy. The two-hole spinal staple is etched to aid in the
correct positioning of the two-hole spinal staple in the construct. The
two-hole spinal staple is available in small, medium and large sizes.
Both the single and two-holed KASS spinal staples are designed
with four tetra-spikes on the underneath side of the staple.
Spinal Screws: The spinal screws are designed with a cancellous
diameter of 6.25mm and will receive a 3/16 inch (4.75mm) diameter
spinal rod. Two types of spinal screws are available for use with the
KANEDA Anterior Scoliosis System. The KASS open and closed
screws are designed with a blunt tip at the end of the cancellous
portion. The standard ISOLA open and closed screws are the
second type of spinal screws. A KASS open screw cap is designed
to be used with all open screws. An ISOLA set screw is used with
both the KASS and standard ISOLA screws. Anteriorly placed
screws are intended for bi-cortical purchase of the vertebral body.
The 6.25mm diameter blunt tip open and closed screws are available
in multiple lengths which range from 25mm to 60mm in varying
millimeter increments. The 6.25mm diameter standard ISOLA open
and closed screws are available in multiple lengths which range from
20mm to 70mm in 5-millimeter increments.
Spinal Rod: The ISOLA spinal rod is 3/16 inch (4.75mm) diameter
and has a smooth surface. The spinal rod is available in an 18 and
24mm length.
All implant components are manufactured of implant grade stainless
steel conforming to ASTM F-138 specifications.
The KANEDA SR Anterior Spinal System
The KANEDA SR Anterior Spinal System is an anterolateral spinal
implant system which is used in conjunction with some components
of the ISOLA Spine System. KANEDA SR consists of longitudinal
members, spinal anchors and transverse rod couplers. The longitu-
dinal members are 1/4 inch (6.35 mm) diameter smooth spinal rods.
The ISOLA rods can be cut to size during the surgical procedure or
KANEDA rods are available in precut lengths. The contoured spiked
plates are designed to help the construct anchors resist axial forces
and serve as a guide for placement of the screws. The plates are
available in three sizes (small, medium and large) and are designed
as pairs with specific caudal and rostral components. The screws
serve to anchor the vertebral bodies to the longitudinal rods and
are available in open and closed screw formats. Caps are available
to capture the rod onto the open screws. Set screws are used to
tighten the screws to the rods. The transverse couplers add stability,
contributing to the construct’s ability to resist torsional loads.
The KANEDA SR Anterior Spinal System is intended for anterolateral
screw fixation to the T10 to L3 levels of the spine, with all metal at
least 1 cm from a major vessel.
All implant components are manufactured of titanium alloy
conforming to ASTM F-136 specifications.

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M-2 Anterior Plate System
The M-2 Anterior Plate System is a construct which consists of one
plate attached to the lateral aspect of the vertebrae by either four
screws or two screws/two bolts. The use of an all screw construct
or a screw/bolt construct is based on surgeon preference. The
components of the M-2 Anterior Plate System have been designed
with anatomic limitations in mind.
The intended levels for treatment with the M-2 Anterior Plate
System are from T3 to L3. In order to treat levels from T3 to L3,
plate attachment is from T2 to L4. The M-2 Anterior Plate System is
intended to treat one motion segment per construct.
M-2 Plate: The M-2 anterior plate is made from ASTM F-136 implant
grade titanium alloy. The plate is contoured in two planes to provide
a more suitable fit of the thoracic, thoracolumbar and lumbar seg-
ments of the spine. Each M-2 plate has two rows of nested slots
at each end of the M-2 plate. The larger sized M-2 plates contain
an additional nested slot centered in the middle of the M-2 plate
for graft fixation. Each nested slot allows 15 degrees of angulation
of an M-2 screw. The letters A and P are etched on the M-2 plate
to identify the anterior and posterior portions of the M-2 plate. A
machined groove on the under side of the posterior aspect of the
plate is designed to prevent rotation of the M-2 bolt.
The M-2 plates are available in six sizes that range from 40mm to
100mm in ten-millimeter increments.
M-2 Screw: The M-2 anterior screw is made from ASTM F-136
implant grade titanium alloy. The M-2 screw has a cancellous thread
diameter of 4.75mm. The M-2 screw provides up to 15 degrees
angulation within each nested slot of the M-2 plate. The M-2 screw
may be placed in all nested slots of the M-2 plate.
The 4.75mm diameter M-2 screws are available in seven lengths that
range from 25mm to 55mm in five-millimeter increments.
M-2 Bolt: The M-2 bolt and M-2 spherical nut are made from ASTM
F-136 implant grade titanium alloy. The M-2 bolt is composed of two
parts: a fully threaded cancellous section with an integral fixed lower
nut and a machine threaded section above the integral nut. An M-2
spherical nut secures the bolt to the M-2 plate. The M-2 bolt has
a cancellous thread diameter of 5.50mm. The integral nut portion
of the M-2 bolt fits into the machined groove beneath the posterior
nested slots of the M-2 plate. An M-2 bolt may be used only in the
inferior and superior posterior nested slots of the M-2 plate.
The 5.50mm diameter M-2 bolts are available in seven lengths that
range from 25mm to 55mm in five-millimeter increments.
Bicortical fixation is recommended for all M-2 screws and bolts.
CAUTION: Bolts are intended for use only in the posterior slots
on the M-2 plate.
UNIVERSITY PLATE Anterior System
CAUTION: This system is intended to treat T10 to L3 with attachment
to T9-L4 and is not suitable for attachment to the sacrum. The plates
are intended to be attached to the lateral aspect of the vertebral
body, and SHOULD NOT be attached to the anterior aspect
(SEE PRECAUTIONS).
UNIVERSITY PLATE Anterior System Plates: The UNIVERSITY
PLATE Anterior System plates are fabricated from ASTM F-136
implant grade titanium alloy. The plates have a contoured low profile
to match the curvature of the lateral aspect of the thoracolumbar
vertebral bodies. Three pairs of nested slots allow a wide range of
screw and bolt placement, while the spherical countersinks allow up
to 15 degrees of screw angulation.
The UNIVERSITY PLATE Anterior System plates are either
rectangular or distally tapered, and come in a variety of lengths.
Distally tapered plates are used at the L4 level to avoid contact with
the common iliac vessels.
The UNIVERSITY PLATE Anterior System Bolts and Screws:
The UNIVERSITY PLATE Anterior System screws are fabricated
from ASTM F-136 implant grade titanium alloy. Bolts are 7.0mm in
diameter and screws are 6.25mm in diameter. Bolts and screws are
available in 5mm length increments. When inserted, the tip of each
bolt or screw should extend one thread through the opposite cortex
of the vertebra to increase holding power.
FRONTIER Anterior Scoliosis System
The FRONTIER Anterior Scoliosis System is a construct that
consists of spinal staples, semi-blunt tip open screws, washers,
and 3/16 inch (4.75mm) diameter spinal rods. The components
of the FRONTIER Anterior Scoliosis System are designed with
the anatomic limitations in mind, therefore minimizing the profile
of the construct.
All implant components are manufactured of titanium alloy
conforming to ASTM F-136 specifications.
The FRONTIER Anterior Scoliosis System is intended for anterolateral
screw fixation to the T4 to L4 levels of the spine, with metal at least
1 cm from a major vessel. The FRONTIER Anterior Scoliosis System
may be used in either thoracoscopic procedures or open procedures.
Contraindications Specific to Thoracoscopic Approach
•Prior surgical procedure in the chest cavity on the side of scoliosis.
•Smaller juvenile patients weighing less than 30kg.
•Larger adolescent patients weighing greater than 80kg.
•Scoliosis associated with osteoporosis
(e.g., neuromuscular patients).
PROFILE Anterior Thoracolumbar
Plate System
The PROFILE Anterior Thoracolumbar Plate System consists
of various lengths of thoracolumbar and high thoracic plates,
cancellous screws, cancellous bolts with locking nuts and screws,
and bone graft screws. The anterior thoracolumbar plates are
implanted using two cancellous bolts placed through the plate’s bolt
slots and fixed with locking nuts and screws, two cancellous screws
placed through the plate’s threaded screw holes, and an optional
graft screw which can be placed through the plate's center slot to
provide fixation between the plate and a strut graft if desired. If used,
the graft screw should not be re-used once it has been threaded
through a plate. High thoracic plates are implanted using four to six
cancellous screws, placed through the plate’s screw holes.
All implant components are manufactured of titanium alloy
conforming to ASTM F-136 specifications.
The intended levels for treatment with the PROFILE Anterior
Thoracolumbar Plate System are from T1-L5.
AEGIS Anterior Lumbar Plate System
The AEGIS Anterior Plate System consists of titanium alloy plates
and screws intended for use as an anteriorly placed supplemental
fixation device via the lateral or anterolateral surgical approach
above the bifurcation of the great vessel or via the anterior surgical
approach, below the bifurcation of the great vessels.
The plates are uniquely shaped to conform to the anatomy of the
anterior spine. They feature screw holes for final fixation to the ver-
tebral bodies. The plates are available in lengths ranging from 15mm
to 25mm. The self tapping cancellous screws have a 5.2mm major
diameter and are available in lengths ranging from 24mm to 36mm.

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All implant components are manufactured of titanium alloy
conforming to ASTM F-136 specifications.
The device is intended as a temporary fixation device until fusion is
achieved. The intended levels for treatment with the AEGIS Anterior
Lumbar Plate System are from L1-S1.
Indications
The AEGIS Anterior Lumbar Plate System is indicated for degenerative
disc disease (DDD) (defined as back pain of discogenic origin with
degeneration of the disc confirmed by history and radiographic
studies), spondylolisthesis, trauma (i.e., fracture or dislocation),
deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
tumor, pseudoarthrosis, and failed previous fusion.
Contraindications Specific to AEGIS Anterior Lumbar
Plate System
•Extensive calcification of the great vessels
•Retroperitoneal fibrosis
•High-grade spondylolisthesis
•Tumor or trauma necessitating multiple vertebral
segment stabilization
BOWTI Anterior Buttress Staple
Spinal System
The BOWTI Anterior Buttress Staple System consists of staples
and screws. The staple is uniquely shaped to conform to the
anatomy of the anterior spine. It features two prongs, which engage
the vertebral body and prevent rotation, and a screw slot for final
fixation. The staples have a 5-degree bend, and are available in two
sizes, 20mm and 24mm. The self-tapping cancellous screws have
a 6.25mm major diameter and are available in lengths of 20mm,
25mm, and 30mm. The components of the BOWTI Anterior Buttress
Staple System are manufactured from titanium and have a smooth
anodized finish.
Indications
The BOWTI Anterior Buttress Staple System, in conjunction
with traditional rigid fixation, is intended for use in spinal fusion
procedures as a means to maintain the relative position of weak
bony tissue such as allografts or autografts. This device is not
intended for load bearing applications.
Contraindications Specific to Anterior Buttress
Staple System
•Smaller juvenile patients weighing less than 30kg.
•Patients with significant osteoporosis or metabolic bone disease.
•Patients with greater than Grade I spondylolisthesis, spondylolysis
or significant bony defect in the lumbar spine.
•Patients with a history of abdominal radiation treatment or
abdominal vascular graft surgery.
•Patients who have had previous abdominal surgery with
significant vascular scarring.
CAUTION: Do not place 2 buttress staples in one vertebral body.
ExPEDIUM Anterior Spine System
The EXPEDIUM Anterior Spine System consists of spinal rods,
monoaxial screws, staples, washers, and cross connectors. The
components of the EXPEDIUM Anterior Spine System are designed
with anatomic limitations in mind, therefore minimizing the profile
of the construct.
The EXPEDIUM Anterior Spine System components are manufac-
tured from titanium alloy conforming to ASTM F-136 specifications.
The EXPEDIUM Anterior Spine System is intended for anterolateral
screw fixation of the T4 to L4 levels of the spine, with metal at least
1 cm from a major vessel. The EXPEDIUM Anterior Spine System
may be used in either thoracoscopic procedures or open procedures.
Contraindications Specific to Thoracoscopic Approach
•Prior surgical procedure in the chest cavity on the side of scoliosis.
•Smaller juvenile patients weighing less than 30kg.
•Larger adolescent patients weighing greater than 80kg.
•Scoliosis associated with osteoporosis
(e.g., neuromuscular patients).
CAUTION: The spinal washer should only be used with the
single-hole staple and monoaxial screw.
INDICATIONS
DePuy Spine anterior spinal systems, with the exception of the
BOWTI Anterior Buttress Staple System, are indicated for:
•degenerative disc disease (ddd) defined as back pain of
discogenic origin with degeneration of the disc confirmed by
history and radiographic studies
•spondylolisthesis
•trauma (i.e., fracture or dislocation)
• spinal stenosis, with the exception of the AEGIS Anterior Lumbar
Plate System
•deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
•tumor
•pseudarthrosis
•previous failed fusion
The BOWTI Anterior Buttress Staple System is intended for anterior
intravertebral body screw fixation/attachment to the T1-S1 spine over
one vertebral body extending into the adjacent intervertebral space.
Specifically, the device is intended for stabilization and buttressing
of bone graft as an aid to spinal fusion. It may be used with other
anterior, anterolateral or posterior spinal systems.
CLEANING AND STERILIZATION
Implants and instruments of the KANEDA, KANEDA SR, M-2,
UNIVERSITY PLATE, FRONTIER, PROFILE, AEGIS, BOWTI, and
EXPEDIUM Anterior Spine Systems may be provided either sterile or
non-sterile and this will be clearly identified on the product labels.
Sterile Implants
For the implants supplied sterile, the contents are sterile unless the
package is damaged, opened, or the expiration date on the device
label has passed. The integrity of the packaging should be checked
to ensure that the sterility of the contents is not compromised.
Remove implants from packaging, using aseptic technique, only after
the correct size has been determined.
PRECAUTION: Do not use implants if the condition of the package
and/or labeling indicates a chance that the devices may not be sterile.
Implants supplied sterilized from the manufacturer must
not be re-sterilized.
Non-sterile Implants
For the implants supplied non-sterile, they will be supplied
clean. ISO 8828 or AORN recommended practices for in-hospital
sterilization should be followed for all components.