TransFasten Posterior SI Fusion System Animation Place Holder

TransFasten Posterior SI Fusion System Animation Launch Showing the Quadracentric Joint Preparation


  • Posterior Approach – Potentially reduces operative time and Neurovascular complications.
  • Posterior SI Fusion Site Preparation – Allows for efficient preparation of the joint and press fit implant placement.
  • A form of “Mortise and Tenon” Stabilization of the SI Joint (a proven and established method of Architectural Stabilization) – The geometry of the TransFasten implant across the joint is designed to stabilize the motion segment without disrupting the anatomy and creating new pain generators.
  • Structural Allograft Implant – Custom allograft implant includes a large trans-joint graft window for accommodating a biologic fusion.

Training Opportunities Available. For more information, contact Captiva Spine direct at 561-277-9480. Visit www.TransFasten.com for more information.

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.

This Press Release can be found at PRWeb.com

Captiva Spine TowerLOX-EXT MIS Extended Tab Pedicle Screw

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

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

 

 

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:
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: OrthoSpineNewsHealio,  Becker’s Spine Review,  Spine-Market.com,  Orthoworld, RYOrtho

Captiva Spine Announces Alpha Launch of the TransFasten Posterior SI Fusion System

TransFasten Posterior SI  Fusion System 

Captiva Spine is a medical device organization located in Jupiter, Florida, dedicated to creating sincere and collaborative relationships to deliver smart, elegant, and intuitive spine fusion solutions. Today, Captiva Spine is announcing the alpha launch of the TransFasten Posterior SI Fusion System.  The TransFasten Posterior SI Fusion System was developed in conjunction with Robert Lins, M.D., Orthopedic Spine Surgeon at The Center for Bone & Joint Surgery of the Palm Beaches.

“My goal was to develop a safe and efficient posterior approach potentially reducing operative time, neurovascular complications, and achieving a quadracentric press fit that neither compresses nor expands the sacroiliac joint,” Dr. Lins explained.  “We are creating a fusion site similar to a mortise and tenon joint used in woodworking for thousands of years.” Dr. Lins continued to explain “TransFasten’s streamlined instrumentation and straightforward procedure provide for efficient joint preparation and precise press fit of a QuadraCentric Implant.”


To explain the QuadraCentric Joint Preparation simply…
A) Dock the QuadraCentric Drill Guide at the SI joint.
B) Ream the implant site.
C) Impact the QuadraCentric Implant and graft material.


“The launch of TransFasten (a posterior SI fusion system) is a key milestone in our drive to deliver clinical and economic value for patients, surgeons, and healthcare facilities,” said Dale Mitchell, President and Founder of Captiva Spine.

  • Posterior Approach – Potentially reduces operative time and Neurovascular complications.
  • Posterior Fusion Site Preparation – Allows for efficient preparation of the joint and press fit implant placement.
  • A form of “Mortise and Tenon” Stabilization of the SI Joint (a proven and established method of Architectural Stabilization) – The geometry of the TransFasten implant across the joint is designed to stabilize the motion segment without disrupting the anatomy and creating new pain generators.
  • Structural Allograft Implant – Custom allograft implant includes a large trans-joint graft window for accommodating a biologic fusion.

Training Opportunities Available. Call Captiva Spine direct at 561-277-9480.


 

Captiva Spine Update: First TransFasten Cases

Captiva Spine Marks First Surgeries Using TransFasten™ Posterior SI Fusion System

Captiva Spine, Inc., which designs, manufactures and distributes elegant and intuitive spine device solutions, announces the first surgeries using the company’s proprietary TransFasten™ Posterior SI Fusion System.


Captiva Spine’s thoughtful solutions for the entire spinal column will be on display at the AAOS (American Academy of Orthopaedic Surgeons) Annual Meeting March 7-9, 2018 in New Orleans at booth 4213.


TransFasten Posterior Sacroiliac Joint Fusion System
TransFasten Posterior SI Fusion System

The first cases using the company’s proprietary TransFasten Posterior SI Fusion System were successfully completed across the USA starting in December 2017.  TransFasten’s use of a favorable posterior approach will potentially reduce operative time and neurovascular complications. With proprietary QuadraCentric joint preparation, TransFasten provides multiple implant contact points for biomechanical stability during fusion.  An initial TransFasten surgeon, Dr. Pedro Ramirez, M.D. of Central Florida Neurosurgery Institute, stated “the intuitive TransFasten instrumentation allows me to place the implant accurately, utilizing a safe posterior approach while obtaining a true biologic fusion of the sacroiliac joint.”  Over the past several years there has been a resurgence in the recognition of the SI Joint as a potential source of low back pain as treatment options for SI Joint dysfunction have advanced.  Captiva Spine is committed to launch devices that align clinical and economic outcomes on behalf of all key stakeholders.  TransFasten is on a track for completion of its alpha launch, and Captiva Spine will be training additional surgeons on this posterior SI approach nationwide as early as the end of March 2018.


Inquiries from tenured professionals looking to partner with a company 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.

Discover Strength Through Connections at www.captivaspine.com.

About Captiva Spine, Inc.
Captiva Spine is 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, fosters the mutual trust and openness needed for Captiva Spine to be a conduit of high quality, smart, elegant, and intuitive patient solutions. 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.


For distribution information, please fill out the form below.

3 + 5 = ?

Barcode UDI compliance captiva spine

Upcoming Deadline for UDI (Unique Device Identification) Compliance

udi-unique-device-identifier

UDI Introduction

You may or may not be aware, as of September 24, 2016 the FDA is requiring a unique numeric or alphanumeric code (Unique Device Identification or UDI) on all labels and packaging for Captiva Spine’s implants. UDI applies to all U.S. industry implantable devices and we intend to make this transition as efficient as possible.

The goal is to establish a system to identify medical devices through their distribution and use, via the entire supply chain to point of use with patients.  We have been developing a process over the past few months to achieve this goal in an unobtrusive way to your work flow.

We will share this process with you over the upcoming months to help track these new identifier’s and allow for any questions you have of this new process. In the meantime, we wanted you to have a better understanding of UDI, so we have outlined information below to get the ball rolling.

Thank you for your continued support of Captiva Spine and we continue to be grateful for any opportunity to support your business.

  1. What is UDI?
  2. UDI General Rule
  3. Why are we doing it?
  4. Benefits of Unique Device Identification
  5. Conclusion

1. What is UDI?

A UDI is a unique numeric or alphanumeric code, which acts as a key to certain basic identifying information about a device, such as the name of the manufacturer and the type of device, and may represent certain other information about the device, such as its expiration date and batch or lot number.

  • Identifier/code on device label and packaging (and, in some cases, on the device itself) Two parts:
    • UDI = DI+PI * Device Identifier (DI) (static) – specific to a device version or model
  • Production Identifier(s) (PI) (dynamic) – one or more currently used control/production identifiers that is lot/batch number, serial number, manufacturing date, expiration date
  • If on the label – then needs to be part of the PI’s
  • Not requiring any changes to currently used PI’s

2. UDI General Rule

  • The label* of EVERY medical device (including all IVD’s) must have a UDI.
  • EVERY device package (contains a fixed quantity of a version or model) must have a UDI.
  • Any other approach is an exception to or alternative from these requirements.

3. Why are we doing it?

In keeping with the purpose and intent of the UDI rule, FDA reiterated that

“the goal is to establish a system for the adequate identification of medical devices through their distribution and use, via the entire supply chain to point of use with patients.”

FDA also stated that the direct mark requirement for implants in the proposed was not included in the final rule

“… because it was presumed that implants would be accompanied by their unique device identifier (UDI) label or package with UDI label up to the point of implantation.”

Healthcare providers have a lot to gain by jumping aboard the UDI train. By standardizing and cleansing source data, they can:

  • gain deeper insight into their spend,
  • prevent pricing and/or unit-of-measure errors,
  • level pricing across departments and facilities, and
  • aggregate spend throughout the supply chain.

4. Benefits of Unique Device Identification

When fully implemented, the UDI system may:

  • Allow more accurate reporting, reviewing and analyzing of adverse event reports so that problem devices can be identified and corrected more quickly.
  • Reduce medical errors by enabling healthcare professionals and others to more rapidly and precisely identify a device and obtain important information concerning the characteristics of the device.
  • Enhance the FDA’s analysis of devices on the market by providing a standard and clear way to document device use in electronic health records, clinical information systems, claim data sources and registries. A more robust post-market surveillance system can also be leveraged to support premarket approval or clearance of new devices and new uses of currently marketed devices.
  • Provide a standardized identifier that will allow manufacturers, distributors and healthcare facilities to more effectively manage medical device recalls.
  • Provide a foundation for a global, secure distribution chain, helping to address counterfeiting and diversion and prepare for medical emergencies.
  • Lead to the development of a medical device identification system that is recognized around the world.

5. Conclusion

UDI can fundamentally change and improve the way we all interact with medical devices. It can improve the way we order, purchase, securely distribute and safely and effectively use these devices. It will also inform cost and quality decisions.

But more importantly, it can vastly improve our understanding of devices, through a variety of focused and effective PMS activities, including longitudinal studies. This will allow for better understanding of the long-term safety and effectiveness of specific devices, their overall risk profile, and the use of devices in specific patient populations. And when problems do arise, we will be able to quickly identify and communicate with the affected patients in ways that simply don’t currently exist.

But all of this requires change. It requires device manufacturers to appropriately apply and use UDI on their device(s) and it requires everyone else involved in any aspect of device distribution and use, to adopt and implement systems to manage devices at their UDI level. And we believe that creative people will do all sorts of interesting and useful things based on a device’s UDI. But this will take significant time and resources to do.

However the end goal is well worth it. Just as we can’t even imagine a grocery store today without UPCs and scanners, we will have a hard time remembering the device world before UDI.
______
If you have any specific questions about UDI, any of our products or just want to give us feedback, please contact customer service directly at 561-277-9480.

______

* This is not original content. These are snippets of the guidelines that have been outlined by the FDA.
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.

 

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

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.

 


 

 

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

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.

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