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Instructions for Use

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As an alternative for providing paper copies, Curiteva is providing Instructions for Use (IFU) in electronic format. The eIFUs are being made available online for US customers only so they can be downloaded, printed, reviewed, and readily available.

  • Sage® Cervical Interbody Fusion System
  • Savant® Lumbar Interbody Fusion System
  • Prodigy® Pedicle Screw System
  • Aptitude® Anterior Cervical Plate System
  • SI-LUTION® Sacroiliac Joint Fusion System
Phone: 256.213.1057 Toll Free: 877.9CURITEVA -or- 877.928.7483
Email: info@curiteva.com

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25127 Will McComb Dr.
Tanner, AL 35671

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Compliance
CuriGraft Viable Allogenic Bone Matrix

CuriGraft® Viable Allogenic Bone Matrix is the next generation allograft containing the three key elements ideal for bone formation, offering a variety of clinical applications, including the spine, upper extremity, foot and ankle and orthopedic oncology. 

Key Features

      • Osteoconductive three-dimensional scaffold with cortical and cancellous components
      • Demineralized cortical bone scaffold. Demineralized cortical bone has been identified to have osteoinductive potential1
      • Viable endogenous bone cells to support osteogenic healing processes 
    • DMSO-FREE cryoprotectant, requiring no rinsing or decanting
    • Proprietary mixture of mineralized cancellous bone along with demineralized cortical fibers
    • Easy-to-use syringe, just thaw and use!
    • Four-hour working window for implantation post thaw
    • Storage: -65°C or colder
Size Product Code
1.0cc C034-0001-MCBMV
2.5cc C034-0025- MCBMV
5.0cc C034-0005- MCBMV
10.0cc C034-0010- MCBMV

Reference: 1) Gruskin, E. et.al., Demineralized bone matrix in bone repair: history and use. Advanced Drug Delivery Reviews, 2012. 64:1063-1077 Biologics

CuriGraft® DBM Putty  - Demineralized Bone Matrix Putty

CuriGraft® DBM Putty is a demineralized bone putty matrix indicated for use in the extremities, posterolateral spine, and pelvis as a bone void filler or for treatment of osseous defects. 

Key Features

      • Product is provided in a ready-to-use syringe
      • Equivalent to iliac crest autograft proven in a preclinical spinal fusion model1
      • Assured osteoinductivity via validated processing
      • Cohesive handling that resists irrigation due to robust biocompatible carrier
      • Patient safety ensured through terminal sterilization and viral inactivation
      • Cortical demineralized bone and a carboxymethyl cellulose (CMC) carrier.
Size Product Code
1.0cc C024-0001-PTYV
2.5cc C024-0025-PTYV
5.0cc C024-0005-PTYV
10.0cc C024-0010-PTYV

 

Reference: 1) Kiely, P.D. et al., (2014) Evaluation of a new formulation of demineralized bone matrix putty in a rabbit posterolateral spinal fusion model. The Spine Journal. September 14(9): 2155-2163.

SI-LUTION

The SI-LUTION® Sacroiliac Joint Fusion System is designed to offer immediate stability and long-term fixation across the sacroiliac (SI) joint. The implants are machined out of Titanium and incorporate the proprietary TRU-LOK® micro-textured surface technology. The cannulated system offers screws in multiple diameters and various lengths with optional static or kinetic stabilization caps to provide an ideal solution for every patient. 

Key Features 

  • Manufactured of Titanium with proprietary surface texturing
  • Large centralized helical fenestrations allow for direct allograft integration
  • Self-harvesting bone channels to harvest and distribute local bone during insertion
  • Simple and easy to use instrumentation
  • Ø7, Ø9.5, Ø12mm fenestrated, fully threaded screws
  • 30 – 70mm lengths in 5mm increments

Stabilization Caps

Kinetic and Static

Savant ALIF

The Savant Anterior Lumbar (ALIF) Interbody Fusion System features three footprints in various heights and lordotic angles offering an ideal fit for every patient.

System Features

  • Manufactured of Titanium Featuring TRU-LOK®
  • Open Architecture
  • Micro-roughness surface texturing produces superior implant contact
  • Comprehensive discectomy instruments
  • Three Footprints (mm): 30W x 24D, 35W x 26D, 40W x 28D
  • 8 – 20mm, offered in 2mm increments
  • Lordosis: 6° and 12°
Savant PLIF

The Savant Posterior Lumbar (PLIF) Interbody Fusion System self-distracting, bulleted tip is offered in three different material types, multiple footprints, heights, and lordosis providing multiple options for the surgeon. The Savant PLIF Interbody Fusion System features instruments that are simple and intuitive to use.

SAVANT PEEK PLIF


Key Features

  • Manufactured of biocompatible PEEK polymer
  • Strategically positioned tantalum radiopaque markers to optimize visibility and placement
  • Multi-directional teeth resist migration
  • Footprints (mm): 22L x 10W, 26L x 10W and 30L x 10W
  • Heights: 6 – 16mm, offered in 1mm increments
  • Lordosis: 0° and 8

SAVANT TITANIUM PLIF


Key Features

  • Manufactured of Titanium Featuring TRU-LOK®
  • Open Architecture
  • Micro-roughness surface texturing produces superior implant contact
  • Footprints (mm): 22L x 10W, 26L x 10W and 30L x 10W
  • Heights: 6 – 16mm, offered in 1mm increments
  • Lordosis: 0° or 8°

SAVANT TITANIUM PLASMA COATED PLIF


Key Features

  • Manufactured of PEEK with a titanium plasma spray coating
  • Optimal Radiolucency
  • Increased surface topography
  • Footprints (mm): 22L x 10W, 26L x 10W and 30L x 10W
  • Heights: 6 – 16mm, offered in 1mm increments
  • Lordosis: 0° and 8°
Savant TLIF

The Savant Transforaminal Lumbar (TLIF) Interbody Fusion System is offered in three different material types, multiple footprints, heights, and lordosis providing multiple options for the surgeon. The convex design offers a more accurate fit to the patient’s anatomy and offers oversized, central lateral graft windows for biologic seeding. The Savant Interbody Fusion System offers Comprehensive discectomy instruments and features instrumentation that allows for better control and more precise implant placement.

SAVANT PEEK TLIF

Key Features

  • Manufactured of biocompatible PEEK polymer
  • Strategically positioned tantalum radiopaque markers to optimize visibility and placement
  • Angled lateral windows on anterior side of implant to retain bone graft material
  • Large back surface area for increased instrument interface
  • Footprints (mm): 28L x 9W, 28L x 11W, 32L x 9W and 32L x 11W
  • Heights: 6 – 16mm, offered in 1mm increments
  • Lordosis: 0° or 8º

SAVANT TITANIUM TLIF

Key Features

  • Manufactured of Titanium Featuring TRU-LOK®
  • Open Architecture
  • Designed to offer immediate stability and long-term fixation
  • Micro-roughness surface texturing produces superior implant contact
  • Footprints (mm): 28L x 9W, 28L x 11W, 32L x 9W and 32L x 11W
  • Heights: 6 – 16mm, offered in 1mm increments
  • Lordosis: 0° or 8°

SAVANT TITANIUM PLASMA COATED TLIF

Key Features

  • Manufactured of PEEK with a titanium plasma spray coating
  • Optimal Radiolucency
  • Titanium porous coating creates topographical properties and provides fluoroscopic endplate visualization
  • Ergonomically shaped anterior edges
  • Footprints (mm): 28L x 9W, 28L x 11W, 32L x 9W and 32L x 11W
  • Heights: 6 – 16mm, offered in 1mm increments
  • Lordosis: 0° or 8º
Aptitude

The Aptitude Cervical Plates feature a slim profile design allowing for a smooth anterior service. The simple and intuitive one-step locking mechanism facilitates complete control by the surgeon during the procedure. The Aptitude system offers streamlined instrumentation to accommodate the needs of the patients and surgeons.

ANTERIOR CERVICAL PLATES

Aptitude Cervical Plate 3.png

Key Features

  • Low-profile Plate
  • Large Graft Window
  • Simple and effective, one-step locking mechanism
  • Pre-Lordosed to match patient anatomy
  • 1-5 level plates
  • 17mm plate width
  • 2.2mm thick

ANTERIOR MIDLINE CERVICAL PLATES

Aptitude Midline Cervical Plate.png

Key Features

  • Small incision, minimizing lateral retraction
  • Narrow width optimizes post-operative visualization of the fusion site
  • Posterior cleats resist slippage and increase torsional stability
  • 1-2 level plates
  • 10.5mm plate width
  • 2.2mm thick

APTITUDE SCREWS

Aptitude Cervical Screws.png

Key Features

  • Ø4.0 and Ø4.5 in 12-18mm lengths (in 2mm increments)
  • Self-Drilling, Self-Tapping, Fixed and Variable Screws
  • Color-coded screws allow for easy identification
  • Same screws used for both Standard and Midline plates

Sage

The Sage Cervical Interbody Fusion System is designed to support cervical loads while maximizing surface between the implant and vertebral bodies. The Interbody is offered in four footprints to accommodate individual patient anatomy while the streamlined instrumentation is designed to aid in consistent and accurate implant placement.

SAGE PEEK CERVICAL

Key Features

  • Manufactured of biocompatible PEEK polymer
  • Tantalum radiopaque markers to optimize visibility and placement
  • Multi-directional aggressive teeth designed to prevent implant migration
  • Large, central graft cavity for packing bone graft
  • Color-coded instruments for easy identification
  • Footprints (mm): 12W x 11D, 14W x 12D, 16W x 13D, and 18W x 14D
  • Heights: 5-12mm, offered in 1mm increments
  • Lordosis: 7°

SAGE TITANIUM CERVICAL

Key Features

  • Manufactured of Titanium with surface texturing
  • Open Architecture
  • Micro-roughness surface texturing produces superior implant contact
  • Designed to ensure a high degree of compressive strength and dimensional stability
  • Footprints (mm): 12W x 11D, 14W x 12D, 16W x 13D, and 18W x 14D
  • Heights: 5-12mm, offered in 1mm increments
  • Lordosis: 7°

SAGE TITANIUM COATED CERVICAL

Key Features

  • Manufactured of PEEK with a titanium plasma spray coating
  • Surface topography produces superior implant contact and construct stability
  • Optimal Radiolucency
  • Self-distracting leading edge to facilitate implant insertion
  • Footprints (mm): 12W x 11D, 14W x 12D, 16W x 13D, and 18W x 14D
  • Heights: 5-12mm, offered in 1mm increments
  • Lordosis: 7°
Prodigy MIS

The Prodigy MIS Pedicle Screw System is designed to minimize the complexity of procedural steps while correcting and stabilizing the posterior thoracolumbar spine through a percutaneous approach. This system provides the same strength and rigidity as the Prodigy Polyaxial Screw System.

PEDICLE SCREW SYSTEM

Key Features

  • Minimized soft tissue disruption
  • Strong interface between rod and rod inserter
  • Undercut square thread designed to prevent cross-threading and tulip head splaying
  • Simple and efficient instruments provide advanced manipulation techniques
  • Available in 4.5, 5.5, 6.5 and 7.5 Diameter
  • Heights: 30-55mm in 5mm increments

MIS ROD

Key Features

  • Bulleted tip to facilitate placement
  • Robust instrument engagement feature
PRODIGY™

The Prodigy Polyaxial Pedicle Screw System is a posterior spinal fixation system designed to enhance the surgical experience by providing surgeons with its comprehensive implant offering and ergonomically designed instrumentation. The low-profile, friction fit design is offered in both standard and reduction geometries.

PRODIGY PEDICLE SCREW SYSTEM

Key Features

  • Self-tapping double lead bone screw threads
  • Continuous friction to maintain tulip position
  • Optimized instrument ports
  • Streamlined rod capture
  • Square thread designed to prevent cross-threading
  • Available in standard and dual-thread cortico-cancellous options
  • 4.5 – 10.5mm diameter
  • Height: 25mm – 110mm lengths
  • 5.5mm pre-bent or straight rod available

PRODIGY REDUCTION PEDICLE SCREWS

Key Features

  • Self-tapping double lead bone screw threads
  • Continuous friction to maintain tulip position
  • Optimized instrument ports
  • Streamlined rod capture
  • Square thread designed to prevent cross-threading
  • Extended tulip height of 23.5mm
  • 26mm of threads
  • Reduction screws offered in 5.5 – 7.5mm in 25mm – 55mm lengths
  • 5.5mm pre-bent or straight rod available

VARIABLE CROSSLINKS

Key Features

  • Versatile crosslink design with adjustable lengths and angle variability
  • Slim profile design
  • Center and lateral set screw features the same T20 hexalobe drive
  • 64-85mm (Gold)
  • 44-65mm (Light Blue)
  • 34-45mm (Green)

OFFSET CONNECTORS

Key Features

  • 20, 25 and 30 open and closed Offset Connectors
  • Connects to a Ø5.5mm rod
  • Accepts the same set screw as the pedicle screws
  • Flanged and smooth options

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