Tag Archive for: 510(k) Clearance

TirboLOX Top View - 50x

Captiva Spine Adds TirboLOX-C Titanium Cervical Cage to 3D Printed Dual Layer Lattice Structure Offering

TirboLOX-C Titanium Cervical CageCaptiva Spine Adds Cervical Cages to TirboLOX™ Dual Layer Lattice Structure 3D Printed Titanium Cage Offering

Jupiter, FL, August 2018 – Captiva Spine is a medical device organization located in Jupiter, Florida, dedicated to delivering smart, elegant and intuitive spinal fusion solutions. Today, Captiva Spine is announcing it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its TirboLOX-C 3D Printed Titanium Cervical Cages.

TirboLOX-C Titanium Cervical Cages

TirboLOX-C Titanium Cervical Cages were created following the principles of biomimicry.   The titanium alloy interbody fusion devices with a dual layer organic lattice structure are formed using advanced 3D printing technologies. This lattice structure features a micro-rough surface topography, interconnected dual porosity, and open architecture.  Titanium alloy implants with micro-rough surface topographies and dual porosity have been shown to promote direct bony on growth, in growth and vascularization. TirboLOX-C’s open architecture is designed to reduce radiographic presence for clear imaging.  TirboLOX-C’s high coefficient of friction creates immediate bidirectional fixation.

Dale Mitchell, President and Founder of Captiva Spine said, “Our design development, incorporating substantial surgeon design input, including dual layer porous 3D printed titanium cages, dates back several years.  The timing for commercialization is excellent, as surgeons’ apparent growing preference for porous 3D printed titanium cages is substantial.  In addition, the recently announced industry acquisitions, that include 3D cage technology, may limit independent distributors’ access to this critical growth technology.  Likewise, we are pleased to make our complete line of TirboLOX 3D printed titanium cages available to support their surgeons’ needs.”  Captiva Spine is able to deliver TirboLOX Cervical’s unique dual layer organic lattice structure with numerous geometries and sizes satisfying a wide range of surgeon preferences.

Captiva Spine’s TirboLOX-C Titanium Cervical Cages are one of five new product launches that will be featured at Booth 1649 during the North American Spine Society (NASS) Annual Meeting held in Los Angles, September 26-28, 2018.

Inquiries from tenured distribution professionals looking to partner with a company to build a relationship for the long run are always welcome.

For sales, contact:
Chip Jones, Director of Sales and Marketing
chip.jones@captivaspine.com or 561-277-9480 ext. 725
or via their website www.captivaspine.com/contact-us.

About Captiva Spine, Inc.

As a privately owned medical device organization founded in 2007, Captiva Spine supports spine surgeons, tenured spine distributors, and healthcare facilities in providing patients with progressive spinal care and an obsessive focus on quality.  They strive to create and maintain sincere, honest, collaborative relationships. By valuing their relationships above all else, it fosters the mutual trust and openness needed for Captiva Spine to be a conduit of high quality, smart, elegant, and intuitive patient solutions. As a family of industry professionals, Captiva Spine takes pride in delivering these solutions responsibly and ethically while never losing sight of what they refer to as the Human Factor: Finding the joy in their daily lives and serving the needs of their customers with sincere, professional enthusiasm.

SEE MORE ABOUT TIRBOLOX-C

This Press Release can be found at PRWeb.com

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Captiva Spine TowerLOX-EXT MIS Extended Tab Pedicle Screw

Captiva Spine Announces TowerLOX-EXT MIS Extended Tab Pedicle Screw Receives Clearance

SEE MORE ABOUT TOWERLOX-EXT

Captiva Spine Receives Clearance to Market TowerLOX-EXT Extended Tab Pedicle Screws

Jupiter, FL, September 2018 – Captiva Spine, Inc., which designs, manufactures and distributes elegant and intuitive spine fusion solutions announced today it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market TowerLOX-EXT® MIS Extended Tab Pedicle Screw complementing its TowerLOX® MIS Pedicle Screw System.

TowerLOX-EXT MIS Extended Tab Pedicle Screw

TowerLOX-EXT MIS Extended Tab Pedicle Screws provide the narrow insertion of an extended tab pedicle screw and the versatility, reliability, and security of a tower-based MIS pedicle screw.  TowerLOX-EXT’s narrow insertion path coupled with TowerLOX’s patented articulating rod delivery/reduction options expand the capabilities of the system.  Most notably, TowerLOX-EXT allows percutaneous tower attachment after the extended tabs have been removed, establishing a new standard for MIS pedicle screw systems. This is especially important intraoperatively, or for use when extending the fusion at a later date.

Dale Mitchell, President of Captiva Spine, stated “The design rationale and goals developed with our surgeon collaborators guided the creation of TowerLOX-EXT Extended Tab Pedicle Screw.  Our intent was to reduce insertion pathway, eliminate counter-torque wound expansion, and retain the versatility provided by TowerLOX’s unique instrumentation for rod delivery, rod reduction, and spondylolisthesis reduction.”

TowerLOX® MIS Pedicle Screw System already supports MIS, mini-open, and open cases with simple and less invasive rod insertion (using patented Pivotec® Technology) and efficient internal/external rod reduction. TowerLOX-EXT screws provide 15mm of controlled built-in rod reduction above the break-off and in-situ tower attachment capabilities provide a MIS rescue/revision option not available with other extended tab systems.

Captiva Spine’s TowerLOX-EXT MIS Extended Tab Pedicle Screw is one of five new product launches that will be featured at Booth 1649 during the North American Spine Society (NASS) Annual Meeting held in Los Angeles, September 26-28, 2018.

Inquiries from tenured distribution professionals looking to partner with a company to build a relationship for the long run are always welcome.

For sales, contact:
Chip Jones, Director of Sales and Marketing
chip.jones@captivaspine.com or 561-277-9480 ext. 725
or via their website www.captivaspine.com/contact-us.

About Captiva Spine, Inc.

As a privately owned medical device organization founded in 2007, Captiva Spine supports spine surgeons, tenured spine distributors, and healthcare facilities in providing patients with progressive spinal care and an obsessive focus on quality.  They strive to create and maintain sincere, honest, collaborative relationships. By valuing their relationships above all else, it fosters the mutual trust and openness needed for Captiva Spine to be a conduit of high quality, smart, elegant, and intuitive patient solutions. As a family of industry professionals, Captiva Spine takes pride in delivering these solutions responsibly and ethically while never losing sight of what they refer to as the Human Factor: Finding the joy in their daily lives and serving the needs of their customers with sincere, professional enthusiasm.

This Press Release can be found at PRWeb.com and is also featured on: OrthoSpineNews, Becker’s Spine Review, Spine-Market.com, TheSpineMarketGroup.com

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TirboLOX Top View - 50x

Captiva Spine Announces TirboLOX-L 3D Printed Titanium Lumbar Cages Receive Clearance

Captiva Spine’s TirboLOX-L™ Dual Layer Organic Lattice Structure 3D Printed Titanium Lumbar Cages Receive Clearance

Jupiter, FL, August 2018 – Captiva Spine is a medical device organization located in Jupiter, Florida, dedicated to delivering smart, elegant and intuitive spinal fusion solutions. Today, Captiva Spine is announcing it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its TirboLOX-L 3D Printed Titanium Lumbar Cages.

TirboLOX-L Titanium Lumbar Cages

TirboLOX-L Titanium Lumbar Cages are created using advanced 3D printing technologies to form titanium alloy interbody fusion devices with a dual layer organic lattice structure. This lattice structure features a micro-rough surface topography, interconnected dual porosity, and open architecture.  Titanium alloy implants with micro-rough surface topographies and dual porosity have been shown to promote direct bony ongrowth, ingrowth and vascularization. TirboLOX-L’s open architecture is designed to reduce radiographic presence for clear imaging.  TirboLOX-L’s high coefficient of friction creates immediate bidirectional fixation.

Dennis Ty, Director of R&D of Captiva Spine declared, “With the advanced capabilities of 3D Additive Manufacturing we were able to create a unique lattice structure similar to trabecular bone incorporating a micro-rough surface for clot retention and early osteogenic cell migration, including a dual layer of porosity with pore sizes specifically designed to promote bone ingrowth and vascularization.  Through substantial surgeon design input we are able to deliver TirboLOX-L’s unique dual layer organic lattice structure with numerous geometries and sizes that appeal to a wide range of surgeon preferences.”

Dale Mitchell, President and Founder of Captiva Spine said, “I am pleased our development team was able to incorporate our proprietary Pivotec® Pivoting TLIF Cage into TirboLOX.  Pivotec technology has been used in thousands of surgeries to address the challenges of controlling cage insertion and angle manipulation during surgery and is now available in a wide range of porous Titanium 3D printed, sterile packaged implants. This is especially important during minimally invasive (MIS) applications where time and safety is always of the essence.”

Captiva Spine’s TirboLOX-L Lumbar Cages are one of five new product launches that will be featured at Booth 1649 during the North American Spine Society (NASS) Annual Meeting held in Los Angles, September 26-28, 2018.

Inquiries from tenured distribution professionals looking to partner with a company to build a relationship for the long run are always welcome.

For sales, contact:
info@captivaspine.com or 561-277-9480
or via their website www.captivaspine.com/contact-us.

About Captiva Spine, Inc.

As a privately owned medical device organization founded in 2007, Captiva Spine supports spine surgeons, tenured spine distributors, and healthcare facilities in providing patients with progressive spinal care and an obsessive focus on quality.  They strive to create and maintain sincere, honest, collaborative relationships. By valuing their relationships above all else, it fosters the mutual trust and openness needed for Captiva Spine to be a conduit of high quality, smart, elegant, and intuitive patient solutions. As a family of industry professionals, Captiva Spine takes pride in delivering these solutions responsibly and ethically while never losing sight of what they refer to as the Human Factor: Finding the joy in their daily lives and serving the needs of their customers with sincere, professional enthusiasm.

SEE MORE ABOUT TIRBOLOX-L

This Press Release can be found at PRWeb.com and is also featured on: OrthoSpineNews, Healio,  Becker’s Spine Review,  Spine-Market.com,  Orthoworld, RYOrtho

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captiva spine larger diameter pedicle screw

MIS Pedicle Screw Systems Receive Additional Clearance For Larger Diameter Pedicle Screws

Captiva Spine Larger Diameter Pedicle Screw

Captiva Spine’s MIS Pedicle Screw Systems Receive Additional FDA Clearance for Larger Diameter Pedicle Screws

Captiva Spine, Inc., announced today that they have received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for larger diameter screws within their TowerLOX MIS Pedicle Screw System and CapLOX II Pedicle Screw System. The additions to their systems include 8.5mm and 9.0mm Polyaxial Screws (non-cannulated, cannulated and reduction) for MIS, Mini-Open and Open cases in 30mm-100mm lengths, while maintaining all of the same instrument compatibilities to the implant. The expansion of Captiva Spine’s line of cannulated and non-cannulated pedicle screws is an example of the company’s promise to continuously provide improvements and enhanced capabilities on behalf of surgeons and patients.

Dale Mitchell, President and Founder of Captiva Spine stated, “We are pleased to know that after successfully supporting over 5000 surgeries with Captiva Spine pedicle screws, that surgeons have come to know our company as providing thoughtful and elegant systems combined with reliable solutions for the growing and diverse clinical needs in spine care.” During the recent introduction of the newest MIS rod inserters, Captiva Spine’s Director of Research and Development, Dennis Ty, said “PivoQuik and PivoRod LP Inserters have been performing as expected, which has resulted in a bigger than expected demand for our reliable rod inserter tools and method.”

In addition to exhibiting at the AAOS (American Academy of Orthopaedic Surgeons) Annual Meeting this week (March 2-4) in Orlando, FL, Captiva Spine has recently updated their TowerLOX web page to include the system enhancements and a new animation to show the PivoQuik inserter in action (www.captivaspine.com/towerlox). Other additions to their website include information about bioactive glass and their newly distributed product, FIBERGRAFT® BG Morsels and Putty. Inquiries from tenured professionals looking to partner with a company that values integrity, commitment, and collaboration to build a relationship for the long run are always welcome. Captiva Spine can be contacted direct by phone at 561-277-9480 or via their website.

About Captiva Spine, Inc.
Captiva Spine is a privately owned medical device organization founded in 2007. Captiva Spine designs innovative medical and surgical apparatus, appliances, devices and instruments to support spine surgeons, tenured spine distributors, and healthcare facilities.  They strive to provide patients with progressive spinal care devices with an obsessive focus on quality and they create and maintain sincere, honest, collaborative relationships.  Valuing their relationships, above all else, fosters the mutual trust and openness needed for Captiva Spine to be a conduit of smart, elegant, and intuitive patient solutions.  Captiva Spine consults with clients, providing valuable research information related to the design of surgical devices and instruments. Captiva Spine operates as a family of industry professionals that take pride in delivering these solutions responsibly and ethically while never losing sight of what they refer to as the Human Factor: Finding the joy in their daily lives and serving the needs of their customers with sincere, professional enthusiasm. Captiva Spine – Strength Through Connections.

DISCOVER MORE ABOUT TOWERLOX

 

DISCOVER MORE ABOUT CAPLOX II

This Press Release can be found on PR.com and is also featured with Becker’s Spine, Helio, and Orthopedic Design & Technology.

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SmartLOX Cervical Plate and Screws

SmartLOX Cervical Plate System Receives Clearance For Enhancements

SmartLOX Cervical Plate System Header Image and Logo

Captiva Spine’s SmartLOX Cervical Plate System Receives Clearance for Enhanced and Patented Screw Locking Mechanism

(SmartLOX™ Cervical Plate System) – Captiva Spine, Inc., a medical device organization dedicated to developing and distributing intelligent and intuitive spine device solutions, announced today it has received 510(K) clearance from the U.S. Food and Drug Administration (FDA) to market an enhanced cervical plate system with a patented screw locking mechanism. Their SmartLOX Cervical Plate System incorporates a proprietary Nitinol self-locking mechanism, which provides visual, audible, and tactile confirmation of the cervical screw locking.

Dale Mitchell, President and Founder of Captiva Spine said, “We are especially pleased about this SmartLOX Cervical Plate System FDA clearance, as it incorporates our enhanced screw locking mechanism design. This enhancement allows screws to be inserted sequentially, in tandem or independently while ensuring a reliable and easy to use locking mechanism. While we all know timing is everything, we couldn’t be more excited to also say that this improvement has recently been allowed a patent by the U.S. Patent and Trademark Office.”

The SmartLOX Cervical Plate System has been engineered for ease of use, enhanced control, and predictable performance. In addition to its proprietary self-locking mechanism, SmartLOX Cervical Plate System features large graft/endplate windows for clear visualization, flush/smooth screw head profile, and options for self-tapping, self-drilling, fixed and variable angled screws. Discover more details about SmartLOX™ Cervical Plate System and Captiva Spine’s other high quality and elegant products, such as the Pivotec® TLIF Cage Inserter and TowerLOX® MIS Pedicle Screw System, at their recently re-launched website www.captivaspine.com.

About Captiva Spine, Inc.
Captiva Spine is a privately owned medical device organization founded in 2007. Captiva Spine designs innovative medical and surgical apparatus, appliances, devices and instruments to support spine surgeons, tenured spine distributors, and healthcare facilities.  They strive to provide patients with progressive spinal care devices with an obsessive focus on quality and they create and maintain sincere, honest, collaborative relationships.  Valuing their relationships, above all else, fosters the mutual trust and openness needed for Captiva Spine to be a conduit of smart, elegant, and intuitive patient solutions.  Captiva Spine consults with clients, providing valuable research information related to the design of surgical devices and instruments. Captiva Spine operates as a family of industry professionals that take pride in delivering these solutions responsibly and ethically while never losing sight of what they refer to as the Human Factor: Finding the joy in their daily lives and serving the needs of their customers with sincere, professional enthusiasm. Captiva Spine – Strength Through Connections.

 

 

DISCOVER MORE ABOUT SMARTLOX

 

This Press Release can be found at PR.com and is also featured on Becker’s Spine, and Healio.

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TowerLOX MIS System - PivoRod LP and Inserter

TowerLOX MIS Pedicle Screw System Enhancements Receive Clearance

PivoQuik Rod Inserter

Captiva Spine’s TowerLOX MIS Pedicle Screw System Receives Clearance for Enhanced Rod Insertion and Reduction

Captiva Spine, Inc., a medical device organization dedicated to creating and maintaining sincere, honest, collaborative relationships to deliver smart, elegant, and intuitive spinal solutions, announced today it has received 510(K) clearance from the U.S. Food and Drug Administration (FDA) to market its enhanced TowerLOX MIS Pedicle Screw System.

These enhancements to the TowerLOX Pedicle Screw System’s already smooth, reliable and predictable tower system for MIS spine surgery include:

  • PivoQuik™ Rod Inserter (patent pending) and Tower Guide – offer simple and quick rod alignment and placement.
  • Modular Open Tower – proprietary locking mechanisms (patent pending) designed to prevent inadvertent tower detachment and allow for rod insertion and visualization through the central shaft of the tower.
  • Reduction Set Screw Driver – allows for rod reduction through the tower without wound expansion while simultaneously driving the set screw thus reducing unnecessary steps.
  • PivoRod LP™ (low profile) – provides efficient rod angle adjustment and “fiddle free” detachment for the inserter.

Captiva Spine continues to add new capabilities to the TowerLOX MIS Pedicle Screw System for surgeons who appreciate controlled, repeatable, and less invasive rod delivery and reduction. Dale Mitchell, President and Founder of Captiva Spine said, “We’ve obsessively invested time collaborating with leading MIS spine surgeons, discovered new resources through our vendor partners, and delivered coordinated enthusiasm through all aspects of this project.” Mitchell also stated that, “During our collaborations with numerous spine surgeons it became very clear that aside from creating a thoughtful and elegant MIS pedicle screw system, it was very important that these enhancements allowed the surgeon to approach challenging surgical situations with confidence.”

Captiva Spine is also excited to present its recently re-designed website www.captivaspine.com, an improved tool for better communication. Inquiries from tenured professionals looking to partner with a company that values integrity, commitment, and collaboration to build a relationship for the long run are always welcome. Captiva Spine can be contacted direct by phone at 561-277-9480 or via their website www.captivaspine.com/contact-us.

About Captiva Spine, Inc.
Captiva Spine is a privately owned medical device organization founded in 2007. Captiva Spine designs innovative medical and surgical apparatus, appliances, devices and instruments to support spine surgeons, tenured spine distributors, and healthcare facilities.  They strive to provide patients with progressive spinal care devices with an obsessive focus on quality and they create and maintain sincere, honest, collaborative relationships.  Valuing their relationships, above all else, fosters the mutual trust and openness needed for Captiva Spine to be a conduit of smart, elegant, and intuitive patient solutions.  Captiva Spine consults with clients, providing valuable research information related to the design of surgical devices and instruments. Captiva Spine operates as a family of industry professionals that take pride in delivering these solutions responsibly and ethically while never losing sight of what they refer to as the Human Factor: Finding the joy in their daily lives and serving the needs of their customers with sincere, professional enthusiasm. Captiva Spine – Strength Through Connections.

DISCOVER MORE ABOUT TOWERLOX

This Press Release can be found at PR.com and is also featured on RYOrtho.com, Healio, and Becker’s Spine.

 

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