Libra - PacHealth Partners · The Libra™ Pedicle Screw System is an implant system used to provide immobilization and stabilization of the lumbar spine while fusion occurs. The

Libra™

No-Touch Pedicle Screw System

S U R G I C A L T E C H N I Q U E

L IBRA™ SURGICAL TECHNIQUE

CONTENTS

Libra™ System Overview .............................................................................................................. 2

SURGICAL TECHNIQUE

1 Pedicle preparation ............................................................................................................. 3

2 Screw insertion and manipulation ........................................................................................ 5

3 Rod selection, bending and placement ................................................................................ 6

4 Initial set screw placement ................................................................................................... 7

5 Rod reduction, maneuvers and rotation ............................................................................... 8

6 Final set screw tightening .................................................................................................... 9

7 Tab removal....................................................................................................................... 10

REVISION PROCEDURES

Set screw removal ................................................................................................................ 11

Pedicle screw removal .......................................................................................................... 11

Prematurely broken off tabs .................................................................................................. 11

Indications, Contraindications, General Conditions of Use ........................................................... 12

Instrument Listing .......................................................................................................................................... 14

Implant Listing................................................................................................................................................... 17

Libra™

No-Touch Pedicle Screw System

2

S P I N A L B A L A N C E

Libra™ System Overview

Aseptically superior and UDI compliant

• All implants are pre-packaged sterile.

• NT² inside™ proprietary guard around the screw and set

screw prevents direct handling of the implants. Asepsis

is improved with our No Touch Technique, reducing

variables in the sterile field that may lead to infections.

• Bar coding on all implant labeling ensures quick and

accurate traceability from the manufacturer to the patient

Versatile

• Instruments are capable of performing complex

maneuvers

• System is designed to be used in trauma, deformity and

degenerative applications

• Cannulated and non-cannulated screws for use in open

or mini-open “guided” techniques

• One pedicle screw driver is used across our full range of

pedicle screws

Agile

• Proprietary locking mechanism between the screw head

and washer afford additional strength and durability

• Extended screw tabs and thread pattern of the set screw

combine to create a self aligning feature when the set

screw is inserted

• Extended tabs facilitate rod reduction, initial and final

tightening of the set screw

• Dual lead thread and conical form provide for optimal

implant to bone purchase and ease of insertion.

ROD IMPLANTSTi6Al4v-ELI

Sterile “No-Touch”Packaging MonoaxialPolyaxial

Straight Rod

Pre-bent Rod

PEDICLE SCREW IMPLANTSTi6Al4v-ELI

Each Pedicle Screw implant includes a Set Screw


3

1 Pedicle preparation

Identify the pedicle and determine the pedicle entry point using

fluoroscopy. Using the bone awl open the pedicle canal by puncturing

the cortical bone (FIG 1). The awl has a shoulder at 15mm to act as a

stop and guard against over plunging.

NOTE: A K-wire is provided in the instrument set to allow the surgeon to perform a mini-open guided technique.

Using a straight or curved probe bore through the perforation to create a

path for the screw (FIG 2).

The depth of the perforation can be measured using depth markings

present on the tip of the pedicle probe or visualized using fluoroscopy.

The sharp probes are usually used in the thoracic vertebrae, the blunt

probes are typically used in lumbar vertebrae.

NOTE: Use of any probe is not recommended with a 4.5mm diameter pedicle screw. Instead the 4.5mm tap is suggested for creating a pathway for the screw. Caution should always be exercised when creating a pathway for any pedicle screw.

The straight or curved pedicle sounder is used to verify the cortex of the

pedicle is intact by placing the distal end of the instrument into the hole

and feeling for any breach of the cortical wall (FIG 3).

S U R G I C A L T E C H N I Q U E

FIG 2: Probes for making a channel (Straight probe shown here)

FIG 3: Sounder to access the channel for breaches (Straight sounder shown here)

FIG 1: Bone awl used to puncture the cortical bone

KWIRE

LB-PROBE

LB-AWL

LB-CPROBE

LB-SOUNDER

LB-CSOUNDER

LB-TAP

4


Tapping (Optional)

Libra™ pedicle screws are self-tapping, however tapping of

the pedicle can improve bone purchase and facilitate screw

insertion. Select the appropriate sized tap which matches the

pedicle screw size. Attach the tap to the ratcheting handle

and tap the pedicle by performing clockwise rotations of the

handle (FIG 4). The taps are marked from 35mm to 50mm in

5mm increments.

A pedicle marker can be placed into the prepared pedicles

as a placeholder while additional pedicles are prepared or

verified under fluoroscopy (FIGURE 5 & 6).

FIG 4: Tapping of the channel, if required

FIG 5: Pedicle marker used as a placeholder

FIG 6: Bone awl and pedicle marker

LB-TAP

LB-MARKER


5

2 Screw insertion and manipulation

Libra™ pedicle screws are available in polyaxial and monoaxial

configurations both in cannulated and solid types. The 4.5mm

diameter screw is available only in a solid configuration. Screws

are color coded based on the diameter. The pedicle screwdriver

is used for insertion of all Libra™ pedicle screws. Use of the

ratcheting handle is required.

Engage the tip of the screwdriver into the head of the screw and

secure the screwdriver to the screw by rotating the knob located

on the screwdriver shaft in a clockwise direction. Remove the

screw from the NT² Inside™ guard (FIG 6).

Insert the screw into the pedicle (FIG 7). Repeat this process

until all screws are placed. The screwdriver is removed from the

screw through counterclockwise turns of the knob located on the

screwdriver shaft.

If soft tissue impingement occurs between the tulip and the

pedicle, use the rocker to retract the tissue. The rocker is placed

on the pedicle screw shaft below the tulip.

To adjust alignment of any screw tulip use the screw head

manipulator (FIG 8).

LB-PSDRIVER

LB-RHANDLE

FIG 7: Insertion of pedicle screw using the pedicle screw driver

FIG 8: Reorienting the tulip for the rods using the screw head manipulator

FIG 6: Removing the screw from the NT2 guard

LB-ROCKER

LB-MANIP

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3 Rod selection, bending and placement

The rod trial assists in determining proper rod length and any

bending which may be required. Straight rods are available

from 35mm to 200mm in length. Curved rods range from

35mm to 120mm in length.

Utilize the rod bender to contour rods as required. Use small

increments to gradually contour the rod. Avoid repeated bend-

ing of rods in the same location.

Use the rod gripper or rod holder to assist with rod placement

and rod manipulation (FIG 9).

FIGURE 9: Rod gripper positioning the rod.

LB-TRIAL

LB-BENDER

LB-GRIPPER

LB-HOLDER


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4 Initial set screw placement

Utilize the set screw driver to remove the implant from the

NT² inside™ guard. Fully engage the set screw driver tip into

the set screw

Insert the set screw into the tulip and allow the set screw and

set screw driver to self align within the tulip, then begin initial

threading. Advance the set screw until it contacts the rod.

Confirm rod and tulip placement are accurate.

NOTE: Should final tightening of the set screw be desired prior to any reduction maneuvers, this can be done with the torque limiting handle and counter torque wrench. The set screw driver and torque limiting handle must also be used to remove a tightened set screw. See final set screw tightening on page 9.

NOTE: If both pedicle screw tabs have broken off prior to construct finalization the persuader can be used to reduce the rod and allow for initial and final tightening of the set screw. See revision procedures on page 11.

FIGURE 10: Initial tightening of the set screw using the set screw driver

LB-SSDRIVER

LB-CTWRENCH

LB-THANDLE

LB-PERSUADER

LB-THANDLE

LB-CTHANDLE

8


5 Rod reduction, maneuvers and rotation

Prior to final tightening of the construct, compression,

distraction, and rotation may be accomplished (FIG. 11).

Be certain the rod is fully seated using the rod pusher.

Utilize the parallel compressor or distractor, as desired.

Set screws can be provisionally hand tightened using the

set screw driver on one side to facilitate the maneuver. Once

accomplished the alternate set screw can be tightened.

If compression or distraction along the rod but not against the

two screws is preferred, the rod holder or rod gripper can be

positioned on the rod to provide a counter-force to compress

or distract against. The rod gripper can also be used for

rotation of the rod.

LB-COMPRESS

LB-DISTRACT

LB-PUSHER

LB-GRIPPER

LB-THANDLE

FIGURE 11: Use of the parallel compressor prior to final set screw tightening

LB-SSDRIVER


9

6 Final set screw tightening

The counter torque wrench, torque limiting handle and set

screw driver are used to do the final tightening.

Connect the torque limiting handle and set screw driver,

insert the set screw driver into and through the counter

torque wrench exposing the distal tip of the screw driver.

Fully seat the screw driver tip into the set screw then engage

the counter torque wrench over the tulip and seat it firmly

around the tulip, screw head and rod. Tighten the set screw

while applying a counter torque until the torque limiting

handle clicks (FIG. 12).

LB-THANDLE

LB-CTWRENCH

LB-SSDRIVER

FIGURE 12: Final tightening using the counter torque wrench

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7 Tab removal

Ensure all screws are correctly placed and the set screws are

tightened. Only then break off and remove the tabs with the

tab breaker (FIG 13).

NOTE: The tab breaker jaws are etched “inner” and “outer”. The “inner” jaw must be placed inside the tulip for the instrument to function properly.

NOTE: If both screw tabs have broken off prematurely the persuader can be used to reduce the rod and allow for initial and final tightening of the set screw. See revision procedures on page 11.

LB-BREAKER

FIGURE 13: Tab breakage using the tab breaker

FIGURE 14: Final construct

LB-PERSUADER

LB-THANDLE

LB-CTHANDLE


11

Set screw removalUse the set screw driver and either the torque limiting handle or ratcheting handle in conjunction with the counter torque

wrench to remove any set screw. Ensure the set screw driver tip is fully engaged in the set screw head prior to removal. The

rod holder can grasp and remove rods once the set screws have been loosened and removed.

Pedicle screw removalThe revision pedicle screwdriver with ratcheting handle is used to remove a pedicle screw. Fully engage the tip of the

revision pedicle screwdriver into the screw head and rotate the driver in a counter clockwise direction until the screw is

completely out of the pedicle.

Prematurely broken off tabs

In situations requiring rod reduction and/or seating of the set screw, the persuader can be used effectively. Both screw

tabs must be removed prior to use of the persuader. The persuader must be prepared by fully opening the aperture.

Turn the upper portion of the instrument counter clockwise until the tangs at the distal portion flex fully outward. Attach

the instrument over the head of the screw and tighten. Use the set screw driver and ratcheting handle to initially seat the

set screw. Attach the counter torque handle to the body of the persuader to provide a counter force ability. Perform final

tightening of the set screw using the torque handle. Turn the upper portion of the persuader counterclockwise until the

instrument disassembles. Then it can be removed.

LB-PERSUADER

LB-THANDLE

LB-CTHANDLE

LB-CTHANDLE

R E V I S I O N P R O C E D U R E

LB-CTWRENCHLB-THANDLE

LB-SSDRIVER

LB-RHANDLE

LB-REVDRIVERLB-RHANDLE

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Description

The Libra™ Pedicle Screw System is an implant system used to provide immobilization and stabilization of the lumbar spine while fusion occurs. The Libra™ System consists of screws, rods, and fastening set screws in various configurations which can be assembled to create a construct that meets the needs of the patient. Screws are provided in monoaxial and polyaxial configurations in a variety of lengths and diameters in either solid or cannulated designs. Rods are provided in a variety of lengths in both straight and pre-bent configurations. Rods can be further shaped inter-operatively with instruments provided to obtain necessary spinal curvature.

All implants in the Libra™ Pedicle Screw System are manufactured from medical grade titanium alloy (Ti6Al4V as per ASTM F136). The pedicle screws are anodized to facilitate size selection. Changes or variation in color during use or preparation do not affect implant quality.

Do not use any of the Libra™ System components with components from any other manufacturer or system unless specifically allowed to do so in this or any other Spinal Balance document. None of the Libra™ implants or implant components should be reused under any circumstances. Specific instruments are provided for implanting the Libra™ implants.

Indications

The Libra™ Pedicle Screw System is intended for immobilization and stabilization of the posterior thoracic, lumbar and sacral/iliac spine (T1-S1/Ilium) in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (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, curvatures (i.e., scoliosis, kyphosis, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.

Contraindications

Do not use the Libra™ Pedicle Screw System in presence of following:

• Any active or suspected latent infection in or about the spine.

• Any mental or neuromuscular disorder which would create an unacceptable risk of fixation failure or complications in post-operative care.

• Bone stock compromised by disease, infection, or prior implantation which cannot provide adequate support and/or fixation to the implant.

• Obesity can produce loads on the spinal system which can lead to failure of the fixation of the device or, to failure of the device itself.

• Fever or hyper-leukocytosis.

• Bony abnormalities preventing safe screw fixation.

• Any patient where implantation would interfere with anatomical structures or negatively affect the expected physiological performance, including cases where the selected implant components would be inappropriately sized to achieve a successful result.

• Wound healing disorders.

• Suspected or documented allergy/intolerance to the implant materials.

• Rapid joint disease, bone absorption, osteomalacia, osteopenia and/or osteoporosis.

• Patients having inadequate tissue coverage over the operative site.

• Pregnancy.

• Excessive local inflammation.

• Other medical (for example : anesthetics risks) or surgical conditions which would preclude the potential benefit of spinal implant surgery, such as the presence of tumors, congenital abnormalities, elevation of sedimentation rate unexplained by other diseases, elevation of white blood cell count, (WBC) or marked left shift in the WBC differential count.

• Any case not needing bone graft and fusion.

• Any case that requires mixing different components or systems.

• Any patient unwilling to comply with postoperative instructions.

• Any case not listed under Indications for Use.

• Alcoholism, drug abuse or pharmaceutical drug dependency.

Complications and Adverse Effects

Use and/or misuse of this system may result in the following list of complications and potential adverse effects:

• Loosening of any or all of the components.

• Disassembly, bending and/or breakage of any or all of the components.

• Inadequate fixation.

• Non-union, delayed union or mal-union.

• Allergic reaction to implant material, debris, corrosion products including metallosis, staining, tumor formation, and/or autoimmune disease.

• Infection.

• Wound healing disorders or hematomas.

• Fracture, damage or penetration of any spinal bone.

• Post-operative change in normal spinal curvature, loss of correction, height.

• Pain, skin penetration, irritation, fibrosis caused by skin pressure by implant components.

• Bursitis.

• Fracture, microfracture, resorption, damage or penetration of any spinal bone at, above, and/or below the level of surgery.

• Herniated nucleus pulposus, disc disruption or disc degeneration at, above or below the level of surgery.

• Dural tears, pseudomeningocele, fistula, persistent CSF leakage, meningitis.

• Loss of sensory and/or motor function including paralysis (complete/incomplete), dysesthesia, hyperesthesia, parasthesia, radiculopathy, pain, numbness, spasms, sensory loss, tingling sensation and/or visual deficit.

• Neuropathy, paraplegia, paraparesis, reflex deficit, irritation, neurological deficit (transient or permanent) and/or muscle loss.

• Scar formation possibly causing neurological compromise or compression around nerves and/or pain.

• Damage to the urological, gastrointestinal, and/or reproductive systems resulting in compromises including urinary retention, loss of bladder control, gastritis, bowel obstruction, loss of bowel control, sterility, consumption, sexual dysfunction etc.

• Decrease in bone density potentially caused by stress shielding.

• Cessation of any potential growth of the operated portion of the spine.

• Loss of or increase in spinal mobility or function.

• Hemorrhage, hematoma, occlusion, seroma, edema, hypertension, embolism, stroke, excessive bleeding, Phlebitis, wound necrosis, wound dehiscence, damage to blood vessels, or other types of cardiovascular system compromise.

• Reproductive system compromise, including sterility, loss of consortium, and sexual dysfunction.

• Limited ability to perform daily activities.

• Continuation of symptoms that were to be treated for by the implantation.

• Change in mental status.

• Development of respiratory problems, e.g. Pulmonary embolism, bronchitis, pneumonia, etc.

• Death.

• Additional surgery may be required to correct some these potential adverse events and/or outcomes.

Indications, Contraindications, and General Conditions of Use


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Precautions

The implantation of the Libra™ Pedicle Screw System is a technically demanding procedure presenting serious risks to the patient. Implantation must be performed only by experienced spinal surgeons who have a thorough knowledge of the Libra™ System, its limitations, and lumbar spine fixation techniques. Knowledge of surgical techniques, proper reduction, selection and placement of implants, and pre- and post-operative patient management are considerations essential to a successful surgical outcome. It is the surgeon’s responsibility to ensure that the operating procedure is performed correctly. The Surgical Technique can be requested from Spinal Balance by calling +1 (419) 530-5940. No manufacturer can be responsible for complications resulting from erroneous indication, wrong choice of implant size, incorrect operating procedure, and incorrect implant component combination. Internal fixation devices such as the Libra™ Pedicle Screw System rely upon individual patient physiological response, and proper use of the device does not guarantee any result. Use of the system off-label is forbidden by Spinal Balance.

The surgeon should consider the level of implantation, the weight of the patient, the patient’s activity level or general conditions and any other factor which may have an impact on the performance of the system based on published fatigue test results of the system.

The Libra™ Pedicle Screw System is available in titanium alloy. It is imperative that this metal does not come into contact in vivo with other dissimilar metals. Accelerated corrosion may occur when two dissimilar metals are in contact within the body environment.

Patients who smoke have been shown to have an increased risk of non-unions. Such patients should be advised of this fact and warned of the potential consequences.

If the patient is involved in an occupation or activity which applies inordinate stress upon the implant (e.g., substantial walking, running, lifting of significant loads, or muscle strain), resultant forces can cause fracture(s) and/or deformation of the device, leading to insufficient rigidity of the construct to promote fusion.

In some cases, progression of degenerative disease may also be so advanced at the time of implantation that they may substantially decrease the expected useful life to the device. In such cases, orthopedic devices may be considered only as a delaying technique or to provide temporary relief.

Patients should be instructed in detail about the limitations of the implants, including but not limited to the impact of excessive loading through patient weight or activity, and should be taught to govern their activities accordingly. Internal fixation appliances are load sharing devices which hold a segment in alignment until healing occurs. If healing is delayed or does not occur, the implant is likely to eventually break due to metal fatigue. An active, debilitated or demented patient who cannot properly use weight supporting devices may be particularly at risk for overstressing the construct leading to deformation or fracture during postoperative rehabilitation.

Appropriate selection, placement and fixation of the spinal system components are critical factors which affect implant service life. Accordingly, strict adherence to the indications, contraindications, precautions, and warnings for this product is essential to potentially maximize service life. (Note: While proper implant selection can minimize risks, the size and shape of human bones present limitations on the size, shape, and service life of implants).

Care must be taken to protect the components from being marred, nicked or notched as a result of a contact with metal or abrasive objects. Alterations will produce defects in surface finish and internal stresses which may become the focal point for eventual breakage of the implant.

Inspection and trial assembly are recommended prior to surgery to determine if the instruments have been damaged during storage or prior procedures. If any components are marred, nicked, scratched, bent, or notched, do not use those components and return them to Spinal Balance.

Sale of this product is restricted to physicians.

Warnings

The safety and effectiveness of pedicle screw systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are: significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to degenerative spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis). The safety and effectiveness of these devices for any other conditions is unknown.

This device is not intended or expected to be the only mechanism of support of the spine. Regardless of the etiology of the spinal pathology for which implantation of this device was chosen, solid biological support is anticipated but is not always obtained. Without solid biological support provided by bony fusion, the device cannot be expected to support the spine indefinitely and will lose effectiveness in any of several modes. These modes include, but are not limited to, bone-metal interface failure, rod fracture or deformation, and/or bone failure.

Potential risks associated with the use of this system, which may require additional surgery, include: device component fracture, loss of fixation, non-union, fracture of the vertebra, neurological injury, vascular or visceral injury, neurological complications, over-distraction, trauma to nerve root or dura, incorrect implant positioning, implant migration, pseudoarthrosis, disc height loss, adjacent level disc degeneration, allergy or inflammation, general adverse effects related to surgical procedures (e.g. anesthesia, infection), subsidence, and expulsion. Risks and potential benefits must be provided to patients for whom this treatment modality is suggested.

This device must not be reused. Reuse may result in patient injury or other complications including but not limited to component fracture and/or deformation, breakage, difficulty with implantation, incompatibility with mating components and infection. It is the physician’s responsibility to discard all damaged or mishandled implants.

Contouring or bending of an implant, may reduce its strength from fatigue and cause its fracture or deformation. If spinal implants (including rods) are excessively bent, bent forward and then backward or otherwise damaged during insertion or adjustment, they may not be implanted and must be replaced. Rods must be contoured with the proper contouring instruments. Incorrectly contoured rods or rods which have been repeatedly or excessively contoured must not be implanted and are to be discarded. See the Libra™ Pedicle Screw System surgical technique for descriptions of appropriate bending and excessive bending of rods.

Internal fixation devices cannot withstand activity and loads equal to those placed on normal healthy bone. Until maturation of the fusion mass is confirmed, do not subject this device to the stress of full weight bearing, or implant fracture or deformation may result.

The Libra™ Pedicle Screw System has not been evaluated for safety and compatibility in the MR environment. It has not been tested for heating, migration or image artifact in the MR environment. The safety of the Libra™ Pedicle Screw System in the MR environment is unknown. Scanning a patient who has this device may result in patient injury.

Sterility of Implants

The implants in the Libra™ Spinal System are provided sterile using irradiation.

Do not clean and/or resterilize implants. Do not reuse or re-implant devices that have contacted tissue and/or bodily fluids. Reprocessing may compromise the integrity of the device and lead to diminished service life and may also result in patient illness, injury, or death. Implants should be stored in their original packaging. Do not remove the implants from packaging unless they are to be used immediately. Prior to removal of the implants from the packaging, verify the integrity of the package and the product expiration date. Do not use products where there is any question of package integrity and similarly, do not use any product after its expiration date.

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Instrument Listing

K15-500 K-Wire (500mm), stainless steel

LB-AWL Bone Awl

LB-BENDER Rod Bender

LB-BREAKER Tab Breaker

LB-THANDLE Torque Limiting Handle

LB-CTHANDLE Counter Torque Handle

LB-RHANDLE Ratcheting Handle

LB-CTWRENCH Counter Torque Wrench

LB-DISTRACT Parallel Distractor


15

LB-COMPRESS Parallel Compressor

LB-GRIPPER Rod Gripper

LB-HOLDER Rod Holder

LB-MANIP Screw Head Manipulator

LB-MARKER Pedicle Marker

LB-PERSUADER Persuader

LB-PUSHER Rod Pusher

LB-ROCKER Rocker

LB-TRIAL Rod Trial

LB-CPROBE Curved Pedicle Probe

LB-PROBE Straight Pedicle Probe

16


LB-CPROBE-S Curved Sharp Probe

LB-PROBE-S Straight Sharp Probe

LB-CSOUNDER Curved Pedicle Sounder

LB-SOUNDER Straight Pedicle Sounder

LB-PSDRIVER Pedicle Screwdriver

LB-REVDRIVER Revision Pedicle Screwdriver

LB-SSDRIVER Set Screw Driver

LB-TAP-45 4.5 mm Screw Tap




CANNULATED SOLID

4.5 x 30mm N/A LP4530

4.5 x 35mm N/A LP4535

4.5 x 40mm N/A LP4540

4.5 x 45mm N/A LP4545

4.5 x 50mm N/A LP4550

5.5 x 30mm LP5530C LP5530

5.5 x 35mm LP5535C LP5535

5.5 x 40mm LP5540C LP5540

5.5 x 45mm LP5545C LP5545

5.5 x 50mm LP5550C LP5550

5.5 x 55mm LP5555C LP5555

5.5 x 60mm LP5560C LP5560

6.5 x 30mm LP6530C LP6530

6.5 x 35mm LP6535C LP6535

6.5 x 40mm LP6540C LP6540

6.5 x 45mm LP6545C LP6545

6.5 x 50mm LP6550C LP6550

6.5 x 55mm LP6555C LP6555

6.5 x 60mm LP6560C LP6560

7.5 x 30mm LP7530C LP7530

7.5 x 35mm LP7535C LP7535

7.5 x 40mm LP7540C LP7540

7.5 x 45mm LP7545C LP7545

7.5 x 50mm LP7550C LP7550

7.5 x 55mm LP7555C LP7555

7.5 x 60mm LP7560C LP7560

Polyaxial Screws Monoaxial Screws

CANNULATED SOLID

4.5 x 30mm N/A LM4530

4.5 x 35mm N/A LM4535

4.5 x 40mm N/A LM4540

4.5 x 45mm N/A LM4545

4.5 x 50mm N/A LM4550

5.5 x 30mm LM5530C LM5530

5.5 x 35mm LM5535C LM5535

5.5 x 40mm LM5540C LM5540

5.5 x 45mm LM5545C LM5545

5.5 x 50mm LM5550C LM5550

5.5 x 55mm LM5555C LM5555

5.5 x 60mm LM5560C LM5560

6.5 x 30mm LM6530C LM6530

6.5 x 35mm LM6535C LM6535

6.5 x 40mm LM6540C LM6540

6.5 x 45mm LM6545C LM6545

6.5 x 50mm LM6550C LM6550

6.5 x 55mm LM6555C LM6555

6.5 x 60mm LM6560C LM6560

7.5 x 30mm LM7530C LM7530

7.5 x 35mm LM7535C LM7535

7.5 x 40mm LM7540C LM7540

7.5 x 45mm LM7545C LM7545

7.5 x 50mm LM7550C LM7550

7.5 x 55mm LM7555C LM7555

7.5 x 60mm LM7560C LM7560

5.5mm Diameter Rods

PREBENT STRAIGHT

35mm LROD35C LROD35

40mm LROD40C LROD40

45mm LROD45C LROD45

50mm LROD50C LROD50

60mm LROD60C LROD60

70mm LROD70C LROD70

80mm LROD80C LROD80

90mm LROD90C LROD90

100mm LROD100C LROD100



150mm N/A LROD150

200mm N/A LROD200

Implant Listing

LSETSCREW

NOTE: Set Screw is included with each “No-Touch” pedicle screw package

Set Screw

17

© 2016 Spinal Balance, Inc. MK 003/A

Spinal Balance, Inc.Nitschke Commercialization Complex1510 N Westwood AveSuite 2040Toledo, OH 43606

419-530-5940 www.spinalbalance.us

Documents

Libra - PacHealth Partners · The Libra™ Pedicle Screw System is an implant system used to provide immobilization and stabilization of the lumbar spine while fusion occurs. The