Instinct Java Spinal Fixation System Guide
Instinct Java Spinal Fixation System Guide
Surgical Technique
Indications/Contraindications 3
Implants 5
Instruments 7
Surgical Technique 13
Kit Contents 37
Zimmer Spine is committed to developing a system that offers low profile implants with high
biomechanical strength. The Instinct Java System is based on optimized technologies that minimize
the overall implant volume without compromising performance.
Comprehensive Proven
Surgical technique Technology
Instinct
System
Versatile Simple
Solutions To use
1
• Reduced head diameter offers more room for graft with a lower construct profile.
• Optimized threads are designed to prevent head splay and cross threading.
• Cortical and cancellous advanced threads are designed to maximize pull-out resistance.
2
Indications/Contraindications
Description
The Instinct Java Spinal Fixation System is installed in order to stabilize one or more vertebral
segments from the thoracic spine to the sacrum during the development of bone tissue, using a
top loading technique.
The Instinct Java Fixation System is comprised of various screws, hooks, autostable hooks, offset,
axial and side-by-side connectors and rods, and was designed to temporarily stabilize spinal
segments by means of an osteosynthesis. This system is supplied only in non-sterile form.
For implanting the system, please refer to the brochures on the device, entitled "Instinct Java:
SURGICAL TECHNIQUE" and "Instinct Java: HOOKS SURGICAL TECHNIQUE".
The Instinct Java Spinal Fixation System should be used in combination with the dedicated
instruments, container base, tray and case lid, in accordance with the information found in the
associated brochure “Instinct Java: SURGICAL TECHNIQUE”.
SN2023‑0-72055 / SN2023-0-82055*
–– Sequoia Adjustable Speedlink II™ Connectors Ref. Nos. 3308-35 / 3309-40 / 3310-50
®
The following devices may also be used in combination with the Instinct Java System, EXCLUDING
the CoCr rods.
726‑4055
The Instinct Java axial and side-by-side connectors may be used in combination with Nex-Link 4.0mm
Ti rods Ref. Nos. 724-120 / 724-240 / 724-360 and Optima™ rods Ø 6.0mm Ref. Nos. SG16XX.
Note: Instinct Java Pedicle Screws may be used with Zimmer DTO 5.5 System, according to the
® ®
instructions for use and the surgical technique of Zimmer DTO 5.5 System. This configuration is
only available outside the US. Zimmer DTO 5.5 Implant is not cleared for the US market.
Indications
The Instinct Java Spinal Fixation System is designed for spinal fixation procedures in skeletally
mature patients performed through a posterior approach.
The Instinct Java Spinal Fixation System is indicated for the temporary realignment and
stabilization of one or more intervertebral segments from the thoracic spine to the sacrum until
bony fusion is obtained.
The Instinct Java Spinal Fixation System is indicated to achieve bony fusion via osteosynthesis
at thoracic, lumbar and/or lumbosacral levels of the spine in documented cases of degenerative
disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history
and radiographic studies), spondylolisthesis, fracture, spinal stenosis, kyphotic or lordotic spinal
deformities, scoliosis, tumor and pseudoarthrosis, or for revision of a failed previous fusion.
*Note: The Java Spinal Fixation System is not cleared for the US market.
3
Contraindications
a. A disorder affecting the normal process of bone remodelling, including but not limited
to severe osteoporosis involving the spine, excessive bone reabsorption, osteopenia, a
primary or metastatic tumor involving the spine, an active infection at the planned point of
intervention or certain metabolic disorders of osteogenesis.
b. Insufficient bone quantity or quality that might compromise rigid fixation of the device.
c. A history of infection.
e. An open wound.
f. A neuromuscular disorder causing an abnormally high load on the device during the fusion
period.
g. Obesity contributes to a spinal overload that may be excessive enough to cause failure in the
fixation of the device or failure of the device itself.
i. Pregnancy.
j. A condition of senility, mental illness or drug addiction. Due to these conditions, the patient
may be particularly unlikely to obey certain limits and recommendations indicated for the
post-operative period, which might lead to failure or other complications.
l. The presence of another medical or surgical condition that may hinder the potential
benefits of the spinal implant surgery, such as the presence of a tumor, a congenital defect,
leukocytosis or a pronounced left shift in the ratio of immature to mature neutrophils.
m. Iliac screws and offset connectors should not be used in cases of tumor or trauma of the
sacrum, when additional screw fixation in S1 is not possible.
4
Instinct Java Implants
5
Pre-Contoured Rod (Ti-Alloy) CoCr Rod
(30–120mm) (200, 300, 400, 500mm)
046W0AN51XXX 046W0AN5XXXX
6
Instinct Java Instruments
7
Polyaxial 3.5 Screwdriver Universal Monoaxial Screwdriver Universal
046W1AN00555 046W1AN00565
Connects to either Rachet Handle to drive and adjust Connects to either Rachet Handle to drive and adjust
polyaxial screws and polyaxial reduction screws. monoaxial screws and monoaxial reduction screws.
Straight Ratchet II
046W1AN00585
8
Blocker Holder Rod Holder
046W1AN00590 046W1AN00620
Used to pick up and insert the blocker into the screw head. Securely holds the rod for placement and positioning in the
May also be used to adjust the screw head alignment prior construct.
to blocker placement.
9
Contraction Forceps Distraction Forceps
046W1AN00810 046W1AN00800
Compresses implants axially along the rod. Distracts implants axially along the rod.
Right Rod Bender Used when rod rotation maneuvers are necessary.
046W1AN00554
Bend the rod in situ.
10
Torque-Limiting T-Handle Countertorque Wrench
046W1AN00650 046W1AN00660
Used in conjunction with the Countertorque Wrench and Provides countertorque leverage for final tightening or
the Final Screwdriver Shaft for final tightening of blockers to blocker removal for polyaxial and monoaxial screws.
10 Nm (90 in-lb).
11
Final Screwdriver Shaft SpeedLink Final Driver Shaft
046W1AN00640 046W1AN00300
Used in conjunction with the Torque-Limiting T-Handle for Final tightens the SpeedLink II System 4.0mm diameter hex.
final tightening of blockers. The SpeedLink Final Driver Shaft can be used with Straight
Ratchet Handle (046W1AN00570) and Ratcheting T-Handle
(046W1AN00580). Do not use with Torque-Limiting T-Handle
(046W1AN00650).
12
Surgical Technique
Pedicle Preparation
Step 1
Pedicle Targeting
Precise positioning of the pedicle entry point is
essential. Proper orientation of the pedicle screw is
dependent upon the position of the pilot hole.
Step 2
Awl
Using the Square Awl, pierce the bone cortex at the
entry point.
13
Step 3
Probe
Insert the Pedicular Probe through the pilot hole
into the pedicle to create a path to guide the screw
through the pedicle into the vertebral body.
Step 4
Step 5
Tapping
Connect the appropriate diameter Tap to the Straight
Ratchet Handle. Insert the Tap into the pedicle and
rotate it clockwise.
14
Inserting the Pedicle Screw
Step 6
Screwdriver Assembly
Connect the Polyaxial 3.5mm or Monoaxial
Screwdriver to the Straight Ratchet Handle.
Step 7
Screw Insertion
Insert the screw through the pedicle pathway until it
reaches the proper dorsal height.
15
Step 8
Instrument Removal
1 Release the Polyaxial or Monoaxial Screwdriver by
unlocking the collet counterclockwise. The sleeve can
then be turned counterclockwise to loosen the screw
head.
Step 9
Rod Bending
Use the rod bender to prepare and contour the rods
by progressive bends until obtaining a shape similar
to that defined by the Trial Rod.
16
Step 10
Rod Insertion
The proximal tip of the Blocker Holder can be used to
adjust the head alignments prior to rod insertion.
Step 11
Blockers
Insert the Blocker Holder into the side of the blocker
marked with an etched cross. Align the Blocker Holder
with the screw head and introduce the blocker.
17
Rod Reduction Options
For any rod approximation, the Instinct Java System offers three options for rod reduction.
Step 12 Option 1
Rod Pusher
For the smallest reductions, the rod pusher can be
used to directly introduce the rod into the screw head.
Step 12 Option 2a
Rod Fork
For moderate reductions, the Rod Fork may be used.
Align the prongs of the forceps vertically in the screw
head dimples. Lock the Rod Fork ratchet mechanism
and use the Rod Fork as a lever to introduce the rod
into the screw head.
18
Step 12 Option 2b
Blocker Placement
Insert the blocker with the Blocker Holder.
Step 12 Option 3a
Alligator Persuader
For substantial reductions, use the Alligator Persuader
to reduce the rod. Align the four prongs at the distal
end of the shaft with the screw head recesses.
Step 12 Option 3b
19
Step 12 Option 3c
Additional Reduction
The handle can be removed by pressing the lateral
button and can be used on the second Persuader
shaft to accomplish bilateral spondy reduction.
Step 12 Option 3d
Step 12 Option 3e
20
Step 12 Option 3f
Persuader Removal
To remove the Persuader, unscrew the knob and
release the handle ratchet. Pull the sleeve back fully
to completely disconnect from the screw head.
21
Step 12 Option 4a-3
Step 12 Option 4b
Screw Insertion
Insert the screw through the pedicle pathway until it
reaches the proper dorsal height.
Step 12 Option 4c
Instrument Removal
To release either the Universal Monoaxial or
2 Polyaxial Screwdriver, loosen the collet by turning it
counterclockwise and unthread the screwdriver from
the screw by turning the ratchet handle clockwise with
1
one hand, while holding the screwdriver sleeve in
place with the other.
22
Step 12 Option 4d
Rod Placement
Insert the rod into the reduction tulip head. Place the
Counter-Torque Wrench Universal over the reduction
screw head and ensure that it is securely seated on
the rod.
Step 12 Option 4e
Reduction
Using the Torque-Limiting Handle and Final Driver,
advance the blocker to reduce the rod. After fully
reducing the rod, final tighten the blocker. An audible
click will indicate that the torque limit has been
reached.
Step 12 Option 4f
Tab Removal
Use the Removal Tab Instrument to remove the
Reduction Screw tabs. Bending the tab medial to
lateral will release it from the tulip head.
23
Compression and Distraction (If Necessary)
Step 13
Step 14
24
Step 15
Final Tightening
Step 16a
Final Tightening
Once all the reduction maneuvers have been
completed, all of the blockers must be locked.
Step 16b
25
Iliac Fixation (if necessary)
Step 17a
Awl
After selecting the entry point, use the Square Awl to
pierce the bone cortex and create a pilot hole.
Step 17b
Probe
Determine the optimal trajectory of the pathway for
the patient’s anatomy. Insert the Probe through the
pilot hole into the ilium to create a path to guide the
screw.
Step 17c
26
Step 17d
Tapping
Connect the appropriate diameter Tap to the Ratchet
Handle. Insert the Tap into the Ilium and advance the
threads by rotating the handle clockwise.
Step 17e
Step 17f
Screw Insertion
Insert the screw into the pilot hole and advance it to
the desired dorsal height by turning the Screwdriver
clockwise.
27
Step 17g
Instrument Removal
To release the screwdriver, loosen the collet by turning
2 it counterclockwise and unthread the screwdriver from
the screw by turning the ratchet handle clockwise with
one hand and holding the driver sleeve in place with
1
the other.
Step 17h
Step 17i
28
Step 17j
Rod Insertion
Select the appropriate length rod and cut to a desired
length. Rods may be bent to facilitate placement.
Place the rod in the lateral connector, followed by
each remaining cephalad pedicle screw.
Step 17k
29
Step 17l
Step 17m
Note: Closed offset connectors are also available and should
be provisionally tightened to main construct rods prior to
provisionally locking the offset rod in the iliac screw tulip
head.
30
Transverse Connector Option
The SpeedLink II Transverse Connector System may be used at the surgeon's discretion if
™
Step 18
Step 19
31
Bone Graft Placement
After all implants have been tightened and the construct completed, bone graft can be applied in
the normal manner.
32
Revision/Removal Option
Step 1
Blocker Removal
Place the Countertorque Wrench on the screw head
and insert the Final Screwdriver Shaft into each
blocker. Turn the Screwdriver counterclockwise to
remove the blocker.
Step 2
If the ring is not set in the rod axis, use the proximal
tip of the Blocker Holder to align the ring in the proper
direction.
33
Step 3
Screw Removal
Engage the Polyaxial 3.5mm Screwdriver tip into the
female star on the screw shank. Screw the sleeve into
the screw head (page 13) and turn the Screwdriver
counterclockwise to remove the screw from the
vertebra.
34
Instrument Disassembly and Cleaning
35
Alligator Persuader
36
Instinct Java Kit Contents
Implants
Part Number Description Standard Kit Quantity
046W0AN00002 Blocker 36
046W0AN24525 Polyaxial Pedicle Screw Ø4.5 L25 2
046W0AN24530 Polyaxial Pedicle Screw Ø4.5 L30 2
046W0AN24535 Polyaxial Pedicle Screw Ø4.5 L35 4
046W0AN24540 Polyaxial Pedicle Screw Ø4.5 L40 4
046W0AN24545 Polyaxial Pedicle Screw Ø4.5 L45 2
046W0AN25525 Polyaxial Pedicle Screw Ø5.5 L25 2
046W0AN25530 Polyaxial Pedicle Screw Ø5.5 L30 2
046W0AN25535 Polyaxial Pedicle Screw Ø5.5 L35 4
046W0AN25540 Polyaxial Pedicle Screw Ø5.5 L40 6
046W0AN25545 Polyaxial Pedicle Screw Ø5.5 L45 6
046W0AN25550 Polyaxial Pedicle Screw Ø5.5 L50 6
046W0AN26530 Polyaxial Pedicle Screw Ø6.5 L30 4
046W0AN26535 Polyaxial Pedicle Screw Ø6.5 L35 6
046W0AN26540 Polyaxial Pedicle Screw Ø6.5 L40 8
046W0AN26545 Polyaxial Pedicle Screw Ø6.5 L45 8
046W0AN26550 Polyaxial Pedicle Screw Ø6.5 L50 8
046W0AN26555 Polyaxial Pedicle Screw Ø6.5 L55 4
046W0AN26560 Polyaxial Pedicle Screw Ø6.5 L60 2
046W0AN27530 Polyaxial Pedicle Screw Ø7.5 L30 2
046W0AN27535 Polyaxial Pedicle Screw Ø7.5 L35 4
046W0AN27540 Polyaxial Pedicle Screw Ø7.5 L40 6
046W0AN27545 Polyaxial Pedicle Screw Ø7.5 L45 6
046W0AN27550 Polyaxial Pedicle Screw Ø7.5 L50 6
046W0AN27555 Polyaxial Pedicle Screw Ø7.5 L55 2
046W0AN27560 Polyaxial Pedicle Screw Ø7.5 L60 2
046W0AN28530 Polyaxial Pedicle Screw Ø8.5 L30 2
046W0AN28535 Polyaxial Pedicle Screw Ø8.5 L35 2
046W0AN28540 Polyaxial Pedicle Screw Ø8.5 L40 4
046W0AN28545 Polyaxial Pedicle Screw Ø8.5 L45 4
046W0AN28550 Polyaxial Pedicle Screw Ø8.5 L50 2
046W0AN28555 Polyaxial Pedicle Screw Ø8.5 L55 2
046W0AN28560 Polyaxial Pedicle Screw Ø8.5 L60 2
046W0AN34525 Monoaxial Pedicle Screw Ø4.5 L25 2
046W0AN34530 Monoaxial Pedicle Screw Ø4.5 L30 2
046W0AN34535 Monoaxial Pedicle Screw Ø4.5 L35 2
046W0AN34540 Monoaxial Pedicle Screw Ø4.5 L40 4
046W0AN34545 Monoaxial Pedicle Screw Ø4.5 L45 4
37
Part Number Description Standard Kit Quantity
38
Implants cont'd.
Part Number Description Standard Kit Quantity
39
Part Number Description Standard Kit Quantity
40
Also Available to Order
Part Number Description
Straight Rods – Ti
046W0AN50030 Straight Rod Ø5.5 L30
046W0AN50040 Straight Rod Ø5.5 L40
046W0AN50050 Straight Rod Ø5.5 L50
046W0AN50060 Straight Rod Ø5.5 L60
046W0AN50070 Straight Rod Ø5.5 L70
046W0AN50080 Straight Rod Ø5.5 L80
046W0AN50090 Straight Rod Ø5.5 L90
046W0AN50100 Straight Rod Ø5.5 L100
CoCr Rods
046W0AN52200 CoCr Rod Ø5.5 L200
046W0AN52300 CoCr Rod Ø5.5 L300
046W0AN52400 CoCr Rod Ø5.5 L400
046W0AN52500 CoCr Rod Ø5.5 L500
41
Also Available to Order
Part Number Description
42
Instruments
Part Number Description Standard Kit Quantity
43
Iliac and Reduction Screw Module Instruments
Part Number Description Standard Kit Quantity
44
Warnings and Precautions
Warnings
a. These devices must be implanted by surgeons who have been properly trained in spinal surgery. The
decision to implant them should only be made after taking into consideration the medical and surgical
indications, contraindications, side effects and precautions for use contained in these instructions
for use.
b. Do not reuse devices labeled for single use only even if a single-use device seems to be intact after
it has been removed. The potential risks related to re-use of the device that might affect the patient’s
health and safety include:
–– The transmission of infectious or viral agents. The cleaning and sterilization methods described in
these instructions for use do not apply to a device that has previously been used.
–– Loss of function and loss of mechanical characteristics of the implant (including possible rupture)
after the first implantation and following removal of the device.
d. Any unused, single-use device that has been exposed to blood, bone, tissue or body fluids must not
be reprocessed or resterilized and must be discarded.
f. Use of the Instinct Java spinal fixation system must always be associated with a surgical procedure
intended to achieve fusion of the vertebral segment(s) being treated.
g. Surgeons must select the size of the implants based on the patient’s anatomy.
h. Surgeons must take into account the fact that the threaded ends of the screws may represent a risk for
soft tissue adjacent to the spine when they are implanted using a bicortical technique.
i. The Instinct Java spinal fixation system has not been evaluated for safety and compatibility in the
magnetic resonance (MR) environment and has not been tested for heating or migration in the MR
environment.
j. The use of transverse connectors in the construct could locally impede some medical procedures such
as lumbar punctures or spinal anaesthesia.
k. The safety and effectiveness of pedicle screw spinal systems have been established only for spinal
conditions with significant mechanical instability or deformity requiring fusion with instrumentation.
These conditions are defined in the product indications for use. The safety and effectiveness of these
devices for any other conditions are unknown.
l. Patients with previous spinal surgery at the level(s) to be treated may have different clinical outcomes
compared to those without a previous surgery
m. The iliac screws and offset connectors provide additional stabilization for an S1 screw. They should be
used only in conjunction with screw fixation in S1.
45
Precautions
PRE-OPERATIVE PRECAUTIONS
a. Patient’s weight: excessive weight, combined with other factors, entails additional stresses that may
cause implants to rupture.
b. Patient’s physical activity: intense physical activity during the fusion period increases the risk of
mobility, deformation or rupture of the implants.
c. Mental handicap: there is increased risk in patients who are unable to follow the surgeon’s
recommendations.
d. Physical handicap: this requires special attention, including in some cases modification of post-
operative physical therapy techniques.
e. Smoking: smoking has been shown to have negative effects on bone fusion, that contributes to the
risk of failure to consolidate. Smokers should be informed of this.
f. Surgeons should take into account the normal capacity of the Instinct Java spinal fixation system
depending on their surgical strategy for a given patient.
g. The implantation of pedicle screw spinal systems should be performed only by experienced spinal
surgeons with specific training in the use of this pedicle screw spinal system because this is a
technically demanding procedure presenting a risk of serious injury to the patient.
h. Some cleaning solutions, such as soda solutions or alkaline cleaners may damage the medical
devices. These solutions must not be used.
PERI-OPERATIVE PRECAUTIONS
Insertion of an implant must be done using the instruments designed and supplied for this purpose and
the technique specific to each device. The details of this insertion are found in the brochure entitled,
“Instinct Java: SURGICAL TECHNIQUE”, supplied by Zimmer Spine.
POST-OPERATIVE PRECAUTIONS
In order to avoid the absence of, or a delay in fusion, close follow-up of the patient for 2-4 months is
recommended. This period corresponds to formation of a bony callus. In order to avoid any failure of
the fixation and related clinical problems, it is also important to explain to patients the need to reduce
mechanical stresses applied to the implanted system. Implants may be removed once fusion has occurred
in order to avoid the “shielding effect” and to restore physiological mechanical loads to the bone
elements. This decision should be made based on the risk/benefit ratio for each patient. This is, as with all
patient care, left to the discretion of the operating surgeon.
46
Materials and Possible Side Effects
Materials
Screws, blocker and connectors from the Instinct Java spinal fixation system are made of a titanium alloy
Ti6Al4V (ISO 5832-3:1996 or ASTM F1472:2008) or Ti Ti6Al4V ELI (ASTM F136:2011). Rods are made of a
titanium alloy Ti6Al4V or Ti6Al4V ELI or cobalt-chromium-molybdenum alloy Cr28Co6Mo (ASTM-1537:11).
Note: Mixing of materials such as a titanium alloy and/or cobalt-chromium-molybdenum alloy with
stainless steel in the same fusion construct is forbidden due to a risk of corrosion.
47
Possible Side Effects
All potential side effects associated with spinal fusion surgery without medical device are possible. With
medical device, the list of potential side effects includes, but is not limited to:
b. Bending or fracture of the implant if fusion is absent or delayed due to prolonged exposure of the
osteosynthesis construct to repeated mechanical stresses.
f. Infection.
j. Modification of the spinal geometric corrections, of the vertebral and/or intervertebral height and/or,
of the reduction in spinal deformities.
k. Vascular and/or neurological injury due to surgical trauma or the presence of the device.
m. Damage to a major blood vessel by compression, erosion or laceration that may lead to thrombosis or
hemorrhaging, either of which may lead to more or less severe disorders or to the death of the patient.
Additional surgery may be required to correct any of these potential side effects.
48
Solutions by the people of Zimmer Spine.
You are devoted to helping your patients reduce their pain and improve their lives.
And the people of Zimmer Spine are devoted to you. We are dedicated to supporting
you with best-in-class tools, instruments and implants. We are driven by the opportunity
to share our unrivaled education and training. We are committed partners who will
do everything in our power to assist you in your quest to provide the absolute best in
spinal care. And we can be counted on always to act with integrity as ethical partners
who are worthy of your trust. We are the people of Zimmer Spine.
Disclaimer
This document is intended exclusively for physicians and is not intended for laypersons.
Information on the products and procedures contained in this document is of a
general nature and does not represent and does not constitute medical advice
or recommendations. Because this information does not purport to constitute any
diagnostic or therapeutic statement with regard to any individual medical case, each
patient must be examined and advised individually, and this document does not
replace the need for such examination and/or advice in whole or in part.
Please refer to the package inserts for important product information, including, but
not limited to, contraindications, warnings, precautions, and adverse effects.
Manufacturer
Zimmer Spine
Cité Mondiale
23, parvis des Chartrons
33080 Bordeaux - France
Tel. +33(0)5 56 00 18 20
Fax +33(0)5 56 00 18 21
[Link]
046E5AN00TEN - Jan.2013 - V6
Lit. N° 06.01811.012 - Ed 2013-01