Operative Technique
spinal implant
system
simple.
effective.
TABLE OF CONTENTS
INTRODUCTION.............................................................. 1
operative TECHNIQUE overview......................... 2
detailed operative TECHNIQUE........................... 3
SITE PREPaRATION...................................................... 3
exposure.................................................................... 3
disc removal............................................................. 3
endplate PREPaRATION............................................ 3
implant sizing.......................................................... 4
bone graft placement.......................................... 4
implant insertion................................................... 5
IMPLANT POSITIONING............................................... 5
removal...................................................................... 5
octane T IMPLANT listing...................................... 6
octane T Instrument listing............................. 6
INDICATIONS FOR USE................................................ 9
general description.............................................. 9
contraindications................................................. 9
warnings and precautions................................ 9
INTRODUCTION
Octane® T Spinal Implants are manufactured from PEEK-OPTIMA® polymer with an open fenestrated
design to accommodate bone graft material. The implants are designed with a chamfered nose to
facilitate insertion and pyramidal teeth to provide implant/bone stability and to resist migration.
The implants are manufactured with tantalum markers for intra-operative and post-operative
radiographic visibility.
1
operative technique OVERVIEW
1
3
5
Remove Disc Material
Insert Trial Spacer
2
Prepare Endplate
4
Insert Bone Graft
6
Insert the Implant
2
Advance the Implant
into Final Position
detailed operative technique
SITE PREPARATION AND EXPOSURE
Expose the surgical site using the Osteotomes and
Kerrisons. Preserve the decorticated bone to pack
the implant prior to insertion if desired.
The surgical site may be exposed by using either
the Straight Nerve Root Retractor with Bayonet or
the 90-degree Angle Nerve Root Retractor.
disc removal
Use the Kerrisons, Pituitary Rongeurs and Curettes
to remove disc material. The Kerrisons can also
be used to remove boney prominences (i.e.
osteophytes) (Figure 1).
ENDPLATE PREPARATION
Options for endplate preparation include Box
Chisels, Paddle Scrapers and Rasps (Figure 2).
The Axial Handle and T-Handle can be used in
conjunction with the Paddle Scrapers and Rasps.
The Box Chisel is removed from the disc space
with the use of the Slap Hammer.
Figure 1
Remove Disc Material
Figure 2
Prepare Endplate
3
IMPLANT SIZING
Choose the appropriate Trial Spacer and attach it to
either the T or Axial Handle. Insert the Trial Spacer
into the intervertebral space in order to determine
which size implant to use (Figure 3).
Fluoroscopy can be used to determine the correct
fit of the implant in the trial space.
Note: The implant sizes do not include the teeth
height which will add 1mm on either side, and the
Trial Spacers are 1mm less than the final implant
height. For example, a 7mm implant will measure
9mm from end to end in height, and the 7mm Trial
Spacer will measure 8mm, allowing for a more
secure fit upon insertion.
BONE GRAFT PLACEMENT
After the implant size has been determined, the
openings on the implant may be tightly packed
with bone graft prior to insertion into the disc
space. Use the Graft Tamp and Bone Graft Filler
Block to pack bone graft into the implant. The Graft
Funnel Tamp and Graft Funnel are used to facilitate
placing bone graft as needed (Figure 4).
Figure 3
Insert Trial Spacer
Figure 4
Insert Bone Graft
4
IMPLANT insertion
Determine the indicated size of implant to be used
based on the Trial Spacer. The Threaded Implant
Inserter is used to hold and insert the implant.
The implant is easily attached to the Threaded
Inserter by placing the threads of the Inserter into
the threaded hole at the end of the implant and
turning the handle clockwise until the implant is
securely engaged into the Inserter (Figure 5).
The implant may now be introduced into the disc
space. Once the position has been confirmed
radiographically, the implant may be released
by turning the silver handle of the Inserter
counterclockwise.
Figure 5
Insert the Implant
IMPLANT POSITIONING
Advance the implant into final position as needed
using the Straight or Angled Impaction Tools
(Figure 6).
Final radiographic confirmation of the implant
placement should be done at this time.
removal
To remove the implant, reattach the Inserter and
use the Slap Hammer to remove the implant from
the disc space.
Figure 6
Advance Implant into
Final Position
5
octane t implant LISTING
Catalog
NumberPart Description
600-9807
600-9809
600-9811
600-9813
600-9815
600-9817
Octane T PEEK 28mm x 10mm x 7mm, 0° Lordosis
Octane T PEEK 28mm x 10mm x 9mm, 0° Lordosis
Octane T PEEK 28mm x 10mm x 11mm, 0° Lordosis
Octane T PEEK 28mm x 10mm x 13mm, 0° Lordosis
Octane T PEEK 28mm x 10mm x 15mm, 0° Lordosis
Octane T PEEK 28mm x 10mm x 17mm, 0° Lordosis
octane t INSTRUMENT LISTING
Catalog
NumberPart Description
600-9000
600-9001
600-9002
600-9003
90° Angled Retractor, 5mm
Bayonet Retractor, 5mm
90° Angled Retractor, 8mm
Bayonet Retractor, 8mm
600-9010
600-9011
Osteotome, 6mm
Osteotome, 9mm
600-9022
600-9023
600-9024
Bayonet Kerrison, 2mm
Bayonet Kerrison, 3mm
Bayonet Kerrison, 4mm
600-9034
600-9035
600-9036
600-9037
Pituitary, 3mm - Straight
Pituitary, 5mm - Straight
Pituitary, 3mm - Upbite
Pituitary, 5mm - Upbite
600-9043
600-9044
600-9045
Ring Curette - Straight
Ring Curette – Right Angled
Ring Curette – Left Angled
6
Catalog
NumberPart Description
600-9053
600-9054
600-9071
Cup Curette - Straight
Cup Curette - Up Angle
Axial Handle
600-9080T-Handle
600-9090
Bone Graft Filler Block
600-9107
600-9109
600-9111
600-9113
600-9115
600-9117
Paddle Scraper, 7mm Gold
Paddle Scraper, 9mm Lt Blue
Paddle Scraper, 11mm Magenta
Paddle Scraper, 13mm Lt Green
Paddle Scraper, 15mm Bronze
Paddle Scraper, 17mm Blue
600-9120
Graft Tamp
600-9130
Slap Hammer
600-9135
Slap Hammer Connector
7
octane t INSTRUMENT LISTING
Catalog
NumberPart Description
600-9150
Graft Funnel
600-9151
Graft Funnel Tamp
600-9164
600-9169
Threaded Inserter (Small Handle)
Threaded Inserter (Large Handle)
600-9174
600-9175
Impaction Tool – Straight
Impaction Tool – Angled
600-9180
600-9181
Rasp Straight
Rasp Angled
600-9207
600-9207
600-9207
600-9207
600-9207
600-9207
Trial Spacer, 7mm (Blue)
Trial Spacer, 9mm (Lt Blue)
Trial Spacer, 11mm (Magenta)
Trial Spacer, 13mm (Lt Green)
Trial Spacer, 15mm (Bronze)
Trial Spacer, 17mm (Blue)
8
Indications for use
inadequate bone stock, bone quality, or anatomical
definition; any case not described in the indications; any
patient unwilling to cooperate with the postoperative
instructions; any time implant utilization would interfere
with anatomical structures or expected physiological
performance.
When used as a vertebral body replacement:
The Octane Spinal Implant is indicated for use in the
thoracolumbar spine (T1 to L5) for partial or total
replacement of a collapsed, damaged, or unstable
vertebral body due to tumor or trauma (i.e., fracture), to
achieve anterior decompression of the spinal cord and
neural tissues, and to restore the height of a collapsed
vertebral body. The Octane device is designed to restore
the biomechanical integrity of the anterior, middle, and
posterior spinal column, even in the absence of fusion for
a prolonged period. The device may be used with allograft
or autograft.
WARNINGS and precautions
The surgeon should be aware of the following:
1. The correct selection of the implant is extremely
important. The potential for success is increased by the
selection of the proper size of the implant. The size and
shape of the human spine presents limiting restrictions of
the size and strength of implants used. No implant can be
expected to withstand the unsupported stresses of full
weight bearing indefinitely.
2. The device is not intended or expected to be the only
mechanism of support of the spine. Regardless of the
etiology of the spine pathology for which the implantation
of this device was chosen, it is the expectation and
requirement that adequate anterior column support
exists, either by virtue of existing anatomy or by means of
a spinal fusion or arthrodesis. Without solid biological
anterior column support, the device cannot be expected
to support the spine indefinitely, and will fail in any of
several modes. These modes may include bone-implant
interface failure, implant failure, or bone failure.
3. The surgeon must ensure that all necessary implants
and instruments are on hand prior to surgery. The device
must be handled and stored carefully, protected from
damage, which includes corrosive environments. They
should be carefully unpacked and inspected prior to use.
4. All instruments must be cleaned and sterilized prior to
use.
5. As with all orthopedic implants, the Octane Spinal
Implants should never be reused, under any
circumstances.
6. Proper implant selection and patient compliance to
postoperative precautions will greatly affect surgical
outcomes. Patients who smoke have been shown to have
increased incidence of nonunion. Therefore, these
patients should be advised of the fact and warned of the
potential consequences.
7. Postoperative care is important. The patient should be
instructed in the limitations of his/her implant and should
be cautioned regarding weight bearing and body stress
on the appliance prior to secure bone healing.
8. Implants must not be reused. Any implant, once used,
should be discarded; even though it may appear
undamaged, it may have small defects and internal stress
patterns which may lead to early breakage.
The Octane Spinal Implants have not been evaluated for
safety and compatibility in the MR environment. The
Octane Spinal Implants have not been tested for heating
or migration in the MR environment.
When used as an intervertebral body fusion device:
The Octane Spinal Implant is intended for spinal fusion
procedures at one or two contiguous levels in the lumbar
spine from L2 to S1 in patients with Degenerative Disc
Disease (DDD,) with up to Grade 1 spondylolisthesis or
retrolisthesis at the involved level(s). DDD is defined as
back pain of discogenic origin, with degeneration of the
disc confirmed by history and radiographic studies.
Patients should be skeletally mature, and have had at
least 6 months of non-operative treatment. The device is
intended for use with autogenous graft, and with
supplemental fixation systems cleared for use in the
lumbosacral spine.
GENERAL DESCRIPTION
The Exactech® Octane® Spinal Implant is an implant
constructed of medical grade Polyetheretherketone,
(PEEKOPTIMA® LT1) as described by ASTM F2026. The
implant incorporates ridges on the superior and inferior
surfaces to resist expulsion. The device is open in the
transverse plain to allow insertion of bone graft prior to
placement, and fenestrated along the sides. The
radiolucent PEEK-OPTIMA® material allows visualization
of the defect site on radiography to assess bone growth,
and incorporates tantalum markers conforming to ASTM
F560 to permit verification of position. The Octane Spinal
Implant is provided sterile:
• The Octane-T Spinal Implant, available in heights
of 7mm to 17mm, in 2mm increments.
CONTRAINDICATIONS
Contraindications include, but are not limited to systemic,
spinal, or localized infection; morbid obesity; signs of
local inflammation; fever or leukocytosis; sensitivity/
allergies to implant materials; any medical or surgical
condition which would preclude the potential benefit of
spinal implant surgery, such as the elevation of
sedimentation rate unexplained by other diseases,
elevation of white blood count (WBC), or a marked left
shift in the WBC differential count; grossly distorted
anatomy due to congenital abnormalities; rapid joint
disease, bone absorption, osteopenia, and/or osteoporosis
(osteoporosis is a relative contraindication since this
condition may limit the degree of obtainable correction,
the amount of mechanical fixation, and/or the quality of
the bone graft); any patient having inadequate tissue
coverage over the operative site or where there is
The implantation of the Octane Spinal Implant is a
technically demanding procedure presenting a risk of
serious injury to the patient, and should only be performed
by experienced spinal surgeons with specific training in
the use of this system.
9
Exactech is proud to have offices and distributors around the globe.
For more information about Exactech products available in your country, please visit www.exac.com
For additional device information, refer to the Exactech Spine–Instructions for Use for a device description, indications, contraindications, precautions and warnings. • For
further product information, please contact Customer Service, Exactech, Inc., 2320 NW 66th Court, Gainesville, Florida 32653-1630, USA. (352) 377-1140, (800) 392-2832 or FAX
(352) 378-2617.
Exactech, as the manufacturer of this device, does not practice medicine, and is not responsible for recommending the appropriate surgical technique for use on a particular
patient. These guidelines are intended to be solely informational and each surgeon must evaluate the appropriateness of these guidelines based on his or her personal medical
training and experience. Prior to use of this system, the surgeon should refer to the product package insert for comprehensive warnings, precautions, indications for
use, contraindications and adverse effects.
The products discussed herein may be available under different trademarks in different countries. All copyrights, and pending and registered trademarks, are property of
Exactech, Inc. This material is intended for the sole use and benefit of the Exactech sales force and physicians. It should not be redistributed, duplicated or disclosed without the
express written consent of Exactech, Inc. ©2011 Exactech, Inc.
PEEK-OPTIMA® polymer is from Invibio®.
352-377-1140
1-800-EXACTECH
www.exac.com
716-11-32
Octane T Operative Technique 1011
*+$716-11-320*