SAGICO USA

Tampa,  FL 
United States
http://sagico.com
  • Booth: 1357


Meaningful collaborations to improve spine science.

Founded in 2017, SAGICO focuses on providing logical surgical solutions for spine surgeons throughout the world. Arion 5° Lordosis Cervical Expandable Implant with Tri-Fix™ and Aria Hybrid Lumbar Expandable with Sure-Fit™ are new  implants available in the US and are the beginning to a larger portfolio of spinal surgical solutions. These implants, along with our FDA cleared OSI pedicle screw system, are on display at our booth.

Brands: Spinal Analytics and Geometrical Implant Co SAGICO Tri-Fix Sure-Fit


 Videos

Aria Lumbar Expandable
Arion Cervical

 Press Releases

  • SAGICO Announces 510(k) Pedicle Screw Clearance for its OSI Spinal System

    Tampa, FL, USA, June 5, 2018: The USA FDA has issued SAGICO another 510(k) for its pedicle screw system, branded and marketed as the OSI Spinal System. The technology in the OSI Spinal System include constructs of monoaxial screws, uniplanar screws, polyaxial screws, reduction screws, locking cap set screws, rods, hooks, monoaxial and multiaxial transverse connectors, and associated surgical instruments. The OSI Spinal System implants are available in a variety of sizes to accommodate individual patient anatomy and pathology conditions. SAGICO’s OSI Spinal System implants are designed to adapt 5.5mm diameter rods; the implants are manufactured from Ti6A14V alloy and offered in a sterile package option.

    Among the surgical usages for the OSI Spinal System, they are intended for use in the non-cervical spine. When used for anterior/anterolateral and posterior, non-cervical pedicle and non-pedicle fixation system, the SAGICO OSI Spinal System is intended to provide additional support during fusion using autograft or allograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities:

    • Degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies);
    • Spondylolisthesis;
    • Spinal stenosis;
    • Curvatures (i.e. scoliosis, kyphosis, and/or lordosis);
    • Pseudoarthrosis; and
    • Failed previous fusion

    SAGICO’s OSI Spinal System were cleared to market by the FDA under a variety of Product Codes to include; Thoracolumbosacral Pedicle Screw System (NKB), Appliance, Fixation, Spinal Intervertebral Body (KWQ) and Appliance, Fixation, Spinal Interlaminal (KWP)

    MORE ABOUT SAGICO: Spinal Analytics & Geometrical Implant Co, (SAGICO) and its principals have many years of spinal industry success spanning multiple continents in more than 60 countries. SAGICO and its affiliates are privately held companies with global partners and shareholders and an aggressive pipeline that includes: novel artificial disk implants (TDR), Porous Titanium interbody technology, Expandable VBR options and unique Pedicle Screw Systems optimized for Complex & Pediatric surgery are just a few of the product lines SAGICO offers. SAGICO’s USA corporate based operations are located in Tampa, Florida.

     

                                                                                                                                                        

    Text Box: DISCLOSURE: We at SAGICO are confident in our products and so should our professional surgeons. A surgeon must always rely on his or her own clinical judgment when deciding whether to use a particular medical appliance that may be applicable for a specific patient and adhere to the package insert, product label and/or instructions for use before using any SAGICO product. SAGICO does not diagnose nor does SAGICO offer medical advice on medical conditions and SAGICO requires that all surgeons be trained in the use of any particular product before using it in surgery. The information presented is intended to demonstrate the depth and future of all of SAGICO’s product lines. Some products may not be available in all markets because product availability is subject to the regulatory and/or medical practices in individual markets. Please contact SAGICO prior to any medical procedures to learn more.
     

    Learn more @: www.SAGICO.co

    To schedule an interview please contact SAGICO in the USA: Telephone: 813-830-3636

    Limited USA and International Distributor Opportunities Remain

  • SAGICO Announces Market Release of Expandable Stand-Alone Cervical Technology

    Tampa, FL, USA, April 11, 2018: Previously, the US FDA issued to SAGICO a 510(k) clearance for the SAGICO IBF (Inter-Body Fusion) System. Contained within the 510(k) was the clearance for the cervical appliance branded as the “ARION”. Per the Indications for Use, “…the Arion Cervical implant is an interbody fusion device intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from (C-2- T-1).” The Indications for Use also states that the Arion Cervical is to be filled with autogenous bone graft material, must be placed via an open anterior approach, and must be used with additional “internal” fixation.

    The Arion Cervical is an expandable PEEK-Optima constructed cage with self-contained internal fixation. Once the blades are deployed, the Arion Cervical offers three points of fixation known as Tri- Fixä, the triple fixation cervical technology. The advanced clinical outcomes of the Arion Cervical are also attributed to the industry leading large grafting window, allowing for superior fusion and limited migration rates. During a presentation at a recent spine conference, James Gibson, President of SAGICO, stated, “The Arion Cervical by SAGICO, when clinically achievable, has a proven track record of success across thousands of implantations in multiple countries. It has been adopted globally as a stand-alone implant because of the unique Tri-Fixä triple fixation cervical technology”.

    The initial 510(k) application that was submitted to the FDA by SAGICO was done so under the auspicious of a “bundled” submission. Per the US FDA Guidance for Industry and Food and Drug Administration Staff, “bundling” refers to the inclusion of multiple devices or multiple indications for use for a device in a single premarket submission, including products subject to the device and biologics license application (BLA) authorities. Multiple devices may include different models within a generic type of device1 or devices that are of differing generic types, such as the Arion Cervical.

    The US FDA has accepted submissions in which multiple indications for use were bundled when the indications presented issues that could be addressed during one review. Applicants like SAGICO are not required to bundle multiple devices or indications but may choose to do so when appropriate. As with any device requirement in a bundled submission, the Arion Cervical satisfied all the applicable statutory and regulatory premarket requirements associated with the product clearance.

     

    The Arion Cervical was cleared by the FDA under the Product Code “OVE”. The OVE Product Code is highly coveted because of its unique features as defined by the FDA. First, the OVE Product Code is unique to cervical appliances that offer “Intervertebral Fusion Devices With Integrated Fixation”. The Arion Cervical achieves such benefit with its proprietary Tri-Fixä, triple fixation cervical technology.

    Additionally, OVE products are intended to stabilize cervical spinal segments to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation. Because of the unique product code afforded this category, the FDA has clearly defined the “Technical Method” for these OVE products and it is stated that the cervical appliance “Acts as a disc spacer and holds bone graft; also includes some form of integrated fixation to maintain stability by direct purchase into the bony vertebral endplates.” The Arion Cervical when fully expanded deploys into the endplates and offers integrated fixation in compliance with the OVE Product Code.

    MORE ABOUT SAGICO: Spinal Analytics & Geometrical Implant Co, (SAGICO) and its principals have many years of spinal industry success spanning multiple continents in more than 60 countries. SAGICO and its affiliates are privately held companies with global partners and shareholders and an aggressive pipeline that includes: novel artificial disk implants (TDR), Porous Titanium interbody technology, Expandable VBR options and unique Pedicle Screw Systems optimized for Complex & Pediatric surgery are just a few of the product lines SAGICO offers. SAGICO’s USA corporate based operations are located in Tampa, Florida.

    Text Box: DISCLOSURE: We at SAGICO are confident in our products and so should our professional surgeons. A surgeon must always rely on his or her own clinical judgment when deciding whether to use a particular medical appliance that may be applicable for a specific patient and adhere to the package insert, product label and/or instructions for use before using any SAGICO product. SAGICO does not diagnose nor does SAGICO offer medical advice on medical conditions and SAGICO requires that all surgeons be trained in the use of any particular product before using it in surgery. The information presented is intended to demonstrate the depth and future of all of SAGICO’s product lines. Some products may not be available in all markets because product availability is subject to the regulatory and/or medical practices in individual markets. Please contact SAGICO prior to any medical procedures to learn more.
     

    Learn more @: www.SAGICO.co

    To schedule an interview please contact SAGICO in the USA: Telephone: 813-830-3636

    Limited USA and International Distributor Opportunities Remain


 New Products for 2018

  • Arion 5° Cervical Expandable Interbody
    Arion 5° Cervical Expandable Interbody is a hybrid cage with internal fixation. The implant is the only cervical implant offering 3 distinct points of fixation: Posterior Expansion Fixation Anterior Blades Serrated Superior...

  • Arion 5° Cervical Expandable Interbody is a hybrid cage with internal fixation. The PEEK Optima cage is bisected by a titanium blade that expands the posterior end of the implant. The narrow entry point and anatomic shape pre-expansion creates an effective entry to the cervical spine and also maintains 5° lordosis post expansion. The internal bladed fixation coupled with the rigid teeth on both superior and inferior ends as well as the posterior expansion creates the Tri-Fix™ system. This device is an excellent solution for adjacent level cases. 
  • Aria Hybrid Expandable Lumbar Interbody
    The Aria Hybrid Expandable Lumbar Interbody is a PEEK-titanium cage that provides an internal locking mechanism through expansion of the cage into the cancellous bone. This device is available in an 8° lordotic as well as parallel options....

  • The Aria Hybrid Expandable Lumbar Interbody is a PEEK-titanium cage that provides an internal locking mechanism through expansion of the cage into the cancellous bone. This device is available in an 8° lordotic as well as parallel options. The footprint is a 10mm x 25mm and is cleared for use on both PLIF and TLIF approaches. The range of these device is from 5.5mm to 16mm.