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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
Prodigy Navigation System
Ap titude Anterior Cervical Plate System
SI-LUTION Sacroiliac Joint Fusion System
SI-LUTION Navigation System
Inspire Lumbar Interbody Fusion System
Inspire Cervical Interbody Fusion System
Prowess Laminoplasty System
Acumen Thoracolumbar Plate 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

PROWESS®LAMINOPLASTY SYSTEM

The PROWESS System provides a comprehensive solution for Laminoplasty procedures and consists of streamlined instrumentation and a variety of plate and spacer options for intraoperative adaptability. The instrumentation are intuitive and maintain secure connections to the implants. The implants are offered in a range of sizes and are color coded for easy visual identification.

Prowess Spacer Plates

4-12mm lengths (in 2mm increments) that work with various Spacers
8mm across neck, 5.7mm across center graft window
Color-coded plates allow for easy identification
Double-bend design, low-profile to allow further contouring
Anterior ridges resist slippage and increase torsional stability
Accepts Ø2.3 x 4mm Self-Tapping Bone Screw for assembly

Prowess Hook Plates

4-12mm lengths (in 2mm increments) that work with various Spacers
8mm across neck
Color-coded plates allow for easy identification
Double-bend design, low-profile to allow further contouring
Anterior ridges resist slippage and increase torsional stability

Prowess Hinge Plates

8mm across neck
Singe-bend design, low-profile to allow further contouring
Anterior ridges resist slippage and increase torsional stability

Prowess Spacers

Titanium or PEEK construction
6mm wide, and 4mm minimum height from posterior face to anterior curve
Implant Inserter grip features
Medial, lateral, and anterior anatomical curvatures
Graft cavities on all sizes
Accepts Ø2.3 x 4mm Self-Tapping Bone Screw for assembly
Titanium Spacers are color-coded for easy identification

Prowess Screws

Ø2.3 and Ø2.7 in 4-12mm lengths (in 2mm increments)
Self-Drilling and Self-Tapping
Color-coded screws allow for easy identification
Works with self-retaining Screw Driver
Same Ø2.3 x 4mm Self-Tapping bone screw assembles Spacer to Spacer Plate

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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