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Spine (Thoracolumbar)

Pioneer STREAMLINE® TL


The Streamline TL Spinal Fixation System allows a rigid construct to be created in the thoracolumbar spine using pedicle screws, set screws, rods, and Streamline TL Crosslinks. The system offers a broad range of implants and instruments, providing the ability to tailor treatment to a specific patient for a more efficient, streamlined,implant experience.


Features:

    Standard polyaxial screw diameters include 5.5mm, 6.5mm, and 7.5mm
    Optional polyaxial screw diameters include 4.5mm, 8.5mm, and 9.5mm
    Screw lengths range from 20mm – 100mm, depending on screw diameter
    Pre-bent, straight and hex end rods available
    Titanium and Cobalt Chrome rods available
    60° conical screw angulation provides intraoperative flexibility
    Friction fit screw head designed for greater control
    Double lead thread design for faster implantation
    Set screw uses a standard T25 drive mechanism
    Robust reduction capabilities

Indications:

    The Streamline TL Spinal Fixation System components are non-cervical spinal fixation devices intended as an adjunct to fusion for use as a pedicle screw (T1 - S2), sacral/iliac screw fixation or as an anterolateral fixation system (T8 - L5). Pedicle screw fixation is limited to skeletally mature patients. These devices are indicated for all of the following indications:
    Degenerative Disc Disease (defined as discogenic back pain 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, Scheuermann’s Disease),
    Tumor
    Stenosis
    Pseudoarthrosis
    Failed previous fusion.

Pioneer QUANTUM® Spinal Rodding System


The Quantum® Spinal Rod System comes complete with polyaxial and fixed pedicle screws, straight and bent rods and crosslinks. Easy to use instrumentation allows for distraction, compression, and high grade Spondylolisthesis reduction. (SFDA approval pending)


Features:

    Camming cap design
    Pivoting rod contact - anvil
    Low profile
    Consistent torque
    Visual, tactile, hard stop
    Flexible, intermediate locking
    Visual & tactile confirmation
    Mechanical stop

Indications:

    Degenerative Instability
    Spinal Fixation
    Congenital Instability
    Tumor
    Trauma

Pioneer CROSS-FUSE® II


Cross-Fuse II is Pioneer’s second generation lateral interbody device. The Cross-Fuse II implant is offered in a variety of widths, lengths and heights to provide multiple treatment options. The implant features graft containment ridges, anatomically designed teeth and anterior holes to providing a strong foundation for proper fusion.


Features:

    Convex
    Parallel and lordotic options
    Multiple width and length offerings
    Indications: IBF
    Bullet-shaped tip to ease implant insertion
    Implant contoured for restoration of natural sagittal alignment
    Large graft windows maximize fusion potential
    Anatomically contoured teeth to resist implant migration
    Composed of PEEK-OPTIMA*, a material with a proven clinical history that provides structural strength
    Nerve monitoring is recommended when performing a lateral procedure

Indications:

    Cross-Fuse PEEK implants are indicated as Interbody Fusion Devices (IBFs).
    Pioneer IBFs are indicated for intervertebral body fusion of the spine in skeletally mature patients. Pioneer IBFs are designed for use with autogenous bone graft to facilitate fusion. One device may be used per intervertebral space. Pioneer IBFs are intended to be used with supplemental spinal fixation cleared for the implanted level, such as the Quantum® System.
    Lumbar IBFs are also intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Lumbar IBFs are to be used in patients who have had six months of non-operative treatment

Pioneer CLARITY® LATERAL RETRACTOR


The Clarity Lateral Retractor implements a straightforward design that translates to easier access and utilizes a lateral approach to the disc space. Independent blade manipulation allows customized access to the surgical site. Simple instrumentation and mechanical function makes this retractor a perfect complement to any lateral surgery.


Features:

    Blade lengths up to 180mm
    Optional vertebral body anchor and disc anchor available
    Up to 50mm access window
    Radiolucent frame
    Independent blade retraction
    Independent vertical blade adjustment
    Independent blade articulation
    Rigid two arm fixation for increased stability
    L4/L5 specific frame available

Indications:

    The Clarity Retractor System instruments are intended to provide access to an operative site during spinal surgery

Pioneer BACFUSE®


The BacFuse Spinous Process Fusion Plate allows the surgeon to achieve fast, supplemental posterior fixation
through a minimally invasive approach.


Features:

    Minimally invasive
    Fixation spikes attach to spinous processes providing additional construct stability
    Innovative design and broad implant offering accommodates a wide range of anatomic variations
    Intended for use with bone graft materials (allograft or autograft) not intended for stand-alone use
    Can be used to achieve supplemental fusion, as indicated, for: (1)TLIF, ALIF, and lateral interbody devices (2)Posterior pedicle fixation devices

Indications:

    The Pioneer BacFuse Device is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions in the non-cervical spine:
    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)
    Tumor
    The Pioneer BacFuse Device is intended for use with bone graft material (i.e. allograft or autograft), and is not intended for stand-alone use.

Bonovo (BOI) ALPS Fixation System


Leading poly-axial fixation system. U-shaped top loading design allows for low profile and an easy to use one-step locking system. 360° polyaxial and 40° lateral design.


Features:

    CT and MRI compatible
    Self-tapping design
    Blunt screw tip
    Screw design allows better fixation, resists migration
    Low profile
    Suitable for patients of all ages

Indications:

    Spinal Deformity
    Degenerative Instability
    Trauma
    Tumor
    Tuberculosis

Bonovo (BOI) Atlas Fixation System


The AF spinal fixation system is a general, all-purpose fracture reduction fixation device. It is composed of screws, angular blocks, transverse links and special purpose distraction and extending devices. The final configuration provides distraction, compression, axial rotation and anteroposterior correction of various deformities of the spine.


Features:

    Top loading operation
    Titanium alloy composition
    Three-dimensional control
    Streamlined final configuration

Indications:

    Spinal Fixation
    Vertebral Fracture
    Tumor

Bonovo (BOI) IFix Fixation System


The IFix system is ideal for short procedures of up to three and four levels. Using a range of rods, plates, blocks, extensions, crosslinks, and connectors, stabilization for a variety of anatomical configurations is possible.


Features:

    Top loading operation
    Titanium alloy composition
    Pre-bent plates
    Universal block allows wide angulation for screw placement
    Side rods secures wider rod-to-screw distance variability

Indications:

    Degenerative Instability
    Spinal Fixation
    Congenital Instability
    Trauma
    Tumor

Bonovo (BOI) CSRS Spondylolisthesis Reduction System


The CSRS is designed to treat spondylolisthesis stage II and III. The system contains U-shaped screws, threaded transpedicular screws, and reduction rods to perform reduction with a minimal amount of hardware.


Features:

    Top loading operation
    Titanium alloy composition
    Low profile
    Streamlined final configuration

Indications:

    Single Segmental Degenerative Spondylolisthesis
    Single Segmental Spinal Instability

Bonovo (BOI) GREAT WALL Fixation System


A flagship model of Bonovo’s line. The Great Wall is designed for scoliosis and is suitable for children. Ease of rotation makes it easy for surgeons to use.


Features:

    Low profile
    Unique rotation method
    Side loading

Indications:

    Scoliosis
    Spinal Deformity
    Tumor
    Tuberculosis

A-Spine Tri-Fix System


The Tri-Fix System is the ideal fixation device for short procedures of up to three and four levels.


Features:

    Top loading operation
    Titanium alloy composition
    Pre-bent plates
    Universal block allows wide angulation for screw placement
    Side rod secures wider rod-to-screw distance variability

Indications:

    Degenerative Instability
    Spinal Fixation
    Congenital Instability
    Trauma
    Tumor

A-Spine Tri-Fix SRS System


The system is designed to treat spondylolisthesis stage II and III where reduction is usually attempted. The case contains U-shaped screws, threaded transpedicular screws, and reduction rods to perform reduction with a minimal amount of hardware.


Features:

    Top loading operation
    Titanium alloy composition
    Low profile
    Streamlined final configuration

Indications:

    Single Segmental Degenerative Spondylolisthesis
    Single Segmental Spinal Instability

A-Spine Tri-Fix RF System


The Tri-fix RF System is a general, all-purpose fracture reduction fixation device. The system contains screws, angular blocks, transverse links and special purpose distraction and extending devices. The final configuration provides distraction, compression, axial rotation and anteroposterior correction of various deformities of the spine.


Features:

    Top loading operation
    Titanium alloy composition
    Three-dimensional control
    Streamlined final configuration

Indications:

    Spinal Fixation
    Fracture
    Tumor

A-Spine CHINA GREAT WALL Fixation System


The Great Wall is designed for scoliosis and is suitable for children. Ease of rotation makes it easy for surgeons to use.


Features:

    Low profile
    Unique rotation method
    Side loading

Indications:

    Scoliosis
    Spinal Deformity
    Tumor
    Tuberculosis

A-Spine Smartloc Polyaxial Fixation System


Smartloc polyaxial screw system provides the advantages of easy manipulation, easier assembly and versatility for multiple applications.


Features:

    Monoaxial screw is specially designed for low profile fixation and with construct rigidity. It provides another solution to polyaxial screw in creating lumbar lordosis when demand for construct strength is significant
    Monoaxial long arm screw allows for reduction of spondylolisthetic vertebrae without additional instruments
    Polyaxial screw features angular freedom of 17º and provides easier assembly even under critical orientation
    Polyaxial long arm design assists the rod and is easy to load. More user friendly to meet surgeon's needs

Indications:

    Spinal Deformity
    Degenerative Instability
    Trauma
    Tumor
    Tuberculosis

A-Spine USA Plate System: Narrow Plate


The Universal Spinal Anterior (USA) Narrow Plate System provides anterior stabilization and fixation for unstable thoracic vertebrae. The Narrow Plate is made from titanium alloy, and used in the thoracic regions of the spine. The design resists pullout/pulloff by virtue of triangulation of screw to plate to screw. Mating threads in the round holes and the neck of self-locking screws constrain screw placement to 90º angle of plate to screw.


Features:

    Low profile, top-loading
    Thin, narrow plate design occupies minimal volume
    Six holes give flexibility of placement
    Lateral plate curvature across width is 15º
    Unicortical penetration reduces potential for vascular injury

Indications:

    Trauma
    Tumor
    Tuberculosis

A-Spine USA Plate System: Straight Plate


The Universal Spinal Anterior (USA) Straight Plate System provides anterior stabilization and fixation for unstable thoracolumbar vertebrae. A combination of Straight Plate, universal screws, self-locking screws, nuts and washers create a rigid, three-dimensional structure that resists pullout/pulloff. The Diamond-Lok Interconnect™ system gives the universal screw good rigidity at angulations up to six degrees from the plate hole axis.


Features:

    Low profile, top-loading
    Angulation of 6º max (from axis of plate hole) for flexible screw placement within vertebral body
    Slotted hole permits placement variations
    Lateral plate curvature of 21º across width
    Unicortical penetration of screw

Indications:

    Trauma
    Tumor
    Tuberculosis

Pioneer BULLET-TIP


The Bullet-Tip VBR/IBF system is designed to be used in an open or minimally invasive approach: bilaterally, unilaterally or transforaminally.


Features:

    Grafts available from 8 to 17mm, in 1mm increments
    Designed for bilateral, unilateral or transforaminal approach
    Highly visible tantalum markers
    Back-cutting teeth guide implant into position and resist migration
    Large graft area for maximum fusion potential
    Bullet-shaped tip for self-distracting insertion
    Convex shape optimizes implant fit
    Composed of PEEK-OPTIMA*, a material with a proven clinical history that provides structural strength

Indications:

    Bullet-Tip PEEK implants are indicated as both Interbody Fusion Devices (IBFs) and Vertebral Body Replacements (VBRs).
    Pioneer VBRs are intended for use in the thoracolumbar spine (T1-L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body.
    VBRs are also indicated for treating fractures of the thoracic and lumbar spine. VBRs are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column, even in the absence of fusion for a prolonged period of time.
    VBRs must be used with the Pioneer Quantum® Spinal Fixation System or supplemental internal fixation systems cleared for the conditions listed above (i.e., tumor or trauma of T1-L5). Additionally, Pioneer VBRs are intended to be used with bone graft.
    Pioneer IBFs are indicated for intervertebral body fusion of the spine in skeletally mature patients. Pioneer IBFs are designed for use with autogenous bone graft to facilitate fusion. One device may be used per intervertebral space. The implants are intended to be used with supplemental spinal fixation cleared for the implanted level, such as the Quantum System.
    Lumbar IBFs are also intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Lumbar IBFs are to be used in patients who have had six months of non-operative treatment

Pioneer P-Plus™ Disc Spacer


P-Plus™ is designed for posterior approaches in the thoracolumbar spine. It offers a variety of lordotic PEEK spacer sizes.


Features:

    Slim design and tapered end for an easy distract-then-rotate technique
    Uniquely convex shape for optimal fit (contact) with endplates
    Three lordosis options
    The lordotic design aims to restore natural sagittal alignment
    Radiographic markers
    Three footprints

Indications:

    DDD
    Spondylolisthesis
    Lumbar Stenosis
    Fusion procedure for Pseudo Arthritis

Pioneer T-Plus™ Disc Spacer


T-Plus™ is a Vertebral Body Replacement System for transforaminal lumbar procedures. It is designed by spine surgeons for spine surgeons with three guiding principles: Ease of insertion; Consistent and proper implant placement for fusion; Intuitive verification of proper implant placement and size.


Features:

    Bullet-shaped tip
    Banana-shaped implant
    Angled-teeth thread on superior and inferior surfaces
    Large central apertures
    Full-height radiographic pin markers
    Angled inserter attachment
    Multiple tamps

Indications:

    DDD
    Spondylolisthesis
    Stenosis
    Fusion procedure for Pseudo Arthritis

A-Spine PEEK Lumbar Disc Spacer


The elastic modulus of Vigor® Plus polymer may be adapted to closely match cortical bone. This characteristic significantly reduces the phenomenon of stress shielding, and promotes better bone fusion.


Features:

    Convex anatomical shape matches vertebral endplates
    Anti-migrate serration designs are for perfect stability within interbody space
    Provides maximum space for bone graft
    Promotes normal lumbar lordosis
    Radiodense marker permits optimal postoperative follow-up
    An extensive range of implants and comprehensive set of instruments adapts to all patient anatomies/situations

Indications:

    DDD
    Spondylolisthesis
    Lumbar Stenosis
    Fusion procedure for Pseudo Arthritis

A-Spine Vigor® Lumbar Disc Spacer (with grafting space)


Designed for posterior approaches in the thoracolumbar spine this disc spacer promotes superior stability.


Features:

    Generous grafting space provides adequate space of sufficient graft volume for long-term stability
    Reverse serration on top and bottom of spacer helps to stabilize the spacer from forward or backward migration
    Rectangular spiral geometry balances the loading stress from the vertebral body to the spacer
    Anatomic design on top and bottom of spacer restores normal lordotic curve. Aggressive curettage of the endplates is not required in achieving optimal endplate support
    PORNET™ advantage creates accelerated in-growth of cancellous bone into the spacers
    Lateral holes provides ease of radiographic evaluation of spacer positioning
    Vertical beams at both lateral sides of spacer provide structural support against longitudinal stress for long-term safety

Indications:

    DDD
    Spondylolisthesis
    Lumbar Stenosis
    Fusion procedure for Pseudo Arthritis

A-Spine Vigor® Lumbar Disc Spacer (with vertical grooves)


Designed for posterior approaches in the thoracolumbar spine this disc spacer promotes superior stability.


Features:

    Subtle micro-motion within the spacer by patented vertical grooves promotes fibrous in-growth in the spacer
    Reverse serration on top and bottom of the spacers helps to stabilize the spacer from forward or backward migration
    Rectangular spiral geometry balances the loading stress from the vertebral body to the spacer
    Anatomic design on top and bottom of the spacer restores normal lordotic curve of the lumbar spine
    Aggressive curettage of the endplates is not required in achieving optimal endplate support
    PORNET™ advantage creates accelerated in-growth of cancellous bone in the spacers

Indications:

    DDD
    Spondylolisthesis
    Lumbar Stenosis
    Fusion procedure for Pseudo Arthritis