Nexxt Spine Receives FDA 510(k) Clearance for 3D Printed Stand Alone Cervical Implants

Medical device company Nexxt Spine, founded in Indiana ten years ago, manufactures its own product line of spinal implants and instrumentation. This month, the company announced that its NEXXT MATRIXX Stand Alone Cervical System has officially received 510(k) clearance from the FDA.

Nexxt Spine first invested in metal 3D printing in 2017 – specifically the Concept Laser technology from GE Additive. The company increased its investment in GE Additive’s metal AM technology this spring with the installation of its fourth and fifth Mlab 100R systems, and also uses Concept Laser’s metal 3D printing to create this latest anticipated line extension of its NEXXT MATRIXX family.

NEXXT MATRIXX Stand Alone Cervical System

The Stand Alone Cervical System includes the surgeon-friendly precision, and excellent design qualities, that are part and parcel of the company’s NEXXT MATRIXX brand of 3D printed porous titanium interbodies.

This particular system is fabricated on GE Additive’s Mlab 3D printer. It is available in multiple screws and footprints, and ensures one-step locking, in addition to several options for drills and inserters as well.

“The NEXXT MATRIXX® Stand Alone Cervical System is a stand-alone anterior cervical interbody fusion system intended for use as an adjunct to fusion at one or two contiguous levels (C2-T1) in skeletally mature patients for the treatment of degenerative disc disease (defined as discogenic neck pain with degeneration of the disc confirmed by history and radiographic studies). These patients should have received at least six weeks of non-operative treatment prior to treatment with the device,” a brochure about the system states. “The NEXXT MATRIXX® Stand Alone Cervical System is to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone and implanted via an open, anterior approach. The NEXXT MATRIXX® Stand Alone Cervical System is intended to be used with the bone screw fixation provided and requires no additional fixation.”

Nexxt Spine is known for combining quality manufacturing with design expertise to create high quality spinal products with unique features. Now, the company can achieve bone biology relevance, cellular scaffolding, and tailored surface topography in one, which is why it is so pleased to introduced its Stand Alone Cervical System to the market.

The system marries the benefits and functionality of a cervical interbody and anterior cervical plate into one product. Designed to reduce the amount of soft tissue damage and irritation, these 3D printed cervical implants come in multiple footprints and heights in order to better fit each individual patient.

“This enhancement of the NEXXT MATRIXX portfolio was the next natural progression for Nexxt Spine. With patient care always top of mind, we strive to develop end products that surgeons prefer and hardware patients can count on. Our Stand Alone Cervical is no exception and will showcase the propensity of NEXXT MATRIXX technology to facilitate the body’s natural power of cellular healing for fortified fusion,” said Nexxt Spine President Andy Elsbury.

Current distributor partners of Nexxt Spine can now pre-order the NEXXT MATRIXX Stand Alone Cervical System.

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[Images: Nexxt Spine]

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Captiva Spine Receives FDA Clearance for 3D Printed Titanium Lumbar Cages

3D printing has been playing a big role in helping people with spinal conditions over the last few years, particularly in terms of implants and other medical devices. But none of these 3D printed spinal solutions can get too far without the necessary clearance from the FDA. Florida-based Captiva Spine, Inc., a privately owned medical device organization that was founded in 2007, recently received 510(k) clearance from the FDA for its 3D printed TirboLOX-L Titanium Lumbar Cages.

“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,” said Dennis Ty, the Director of R&D of Captiva Spine. “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.”

The company helps spine surgeons, healthcare facilities, and tenured spine distributors that work to provide patients with progressive, high quality spinal care. It’s dedicated to providing elegant and intuitive spinal fusion solutions, such as its TirboLOX-L Titanium Lumbar Cages. This spinal implant uses 3D printing to form interbody fusion devices, made out of titanium alloy, with a double layer organic lattice structure.

The lattice structure has an open architecture, a micro-rough surface topography, and interconnected dual porosity. The architecture can help lower radiographic presence to ensure clear imaging, while implants that possess the latter two features have shown that they can promote bone ingrowth, ongrowth, and vascularization. In addition, Captiva’s TirboLOX-L has a high coefficient of friction, which, as the company puts it, “creates immediate bidirectional fixation.”

Some of the main benefits of 3D printed porous titanium alloy cages, like the TirboLOX-L lumbar cages made of Titanium Alloy (Ti-6Al-4V), is bone’s ability to successfully grow within its architecture, which can then help it achieve good kinematic properties. The TirboLOX-L Titanium Lumbar Cage also features the company’s Pivotec technology.

“I am pleased our development team was able to incorporate our proprietary Pivotec Pivoting TLIF Cage into TirboLOX,” said Dale Mitchell, the President and Founder of Captiva Spine. “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.”

With FDA clearance, Captiva is now cleared to take its 3D printed TirboLOX-L Titanium Lumbar Cage to market. This device is also one of five new product launches that the company is featuring at the upcoming North American Spine Society (NASS) Annual Meeting later this month in Los Angeles. Stop by its booth #1649 at the meeting to see the other four.

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3D Printing News Briefs: June 29, 2018

In today’s 3D Printing News Briefs (the last one this month, how is the summer going by so quickly?!), a few companies are announcing special honors and recognitions, and then we’re sharing stories stories about some interesting new 3D printing projects, and finally wrapping things up before the weekend with some business news. Renishaw’s Director of R&D has been honored by the Royal Academy of Engineering, while MakerBot earned an important designation for its 3D printing certification program for educators and Renovis Surgical Technologies received FDA approval for its new 3D printed implant. Festo is introducing three new bionic robots, one of which is partially 3D printed, and CINTEC is using 3D printing for its restoration of a famous government house. GE wants to use blockchains for 3D printing protection, and ExOne announced a global cost realignment.

Royal Academy of Engineering Honors Renishaw’s Chris Sutcliffe

Earlier this week, the Royal Academy of Engineering (RAE) awarded a Silver Medal to Professor Chris Sutcliffe, the Director of Research and Development of the Additive Manufacturing Products Division (AMPD) for global metrology company Renishaw. This award is given to recognize outstanding personal contributions to British engineering, and is given to no more than four people a year. The Silver Medal Sutcliffe received was in recognition of his part in driving the development of metal 3D printed implants in both human and veterinary surgery, and also celebrates his successful commercialization of 3D printed products with several companies, including Renishaw, and the University of Liverpool.

“Throughout my career I’ve worked hard to commercialise additive manufacturing technology. As well as AM’s benefit to the aerospace and automotive sectors, commercialisation of AM and associated technologies has been lifechanging for those with musculoskeletal diseases,” said Sutcliffe. “The award celebrates the successes of the engineers I have worked with to achieve this and I am grateful to receive the award to recognise our work.”

MakerBot’s Certification Program for Educators Gets Important Designation

One of the leaders in 3D printing for education is definitely MakerBot, which has sent its 3D printers to classrooms all over the world. Just a few months ago, the company launched a comprehensive, first of its kind 3D printing certification program, which trains educators to become 3D printing experts and create custom curriculum for STEAM classrooms. An independent review of the program showed that it meets the International Society for Technology in Education (ISTE) standards, and it has earned the prestigious ISTE Seal of Alignment from the accreditation body. In addition, a survey conducted over the last three years of over 2,000 MakerBot educators shows that the percentage of teachers reporting that MakerBot’s 3D printers met their classroom needs has doubled in just two years.

“This data shows that MakerBot isn’t just growing its user base in schools. We’re measurably improving teachers’ experiences using 3D printing,” said MakerBot CEO Nadav Goshen. “Much of this impressive teacher satisfaction is thanks to the effort we’ve put into solving real classroom problems—like the availability of 3D printing curriculum with Thingiverse Education, clear best practices with the MakerBot Educators Guidebook, and now training with the new MakerBot Certification program.”

Earlier this week, MakerBot exhibited its educator solutions at the ISTE Conference in Chicago.

FDA Grants Clearance for 3D Printed Interbody Spinal Fusion System 

California-headquartered Renovis Surgical Technologies, Inc. announced that it has received 510(k) clearance from the FDA for its Tesera SA Hyperlordotic ALIF Interbody Spinal Fusion System. All Tesera implants are 3D printed, and use a proprietary, patent-pending design to create a porous, roughened surface structure, which maximizes biologic fixation, strength, and stability to allow for bone attachment and in-growth to the implant.

The SA implant, made with Renovis’s trabecular technology and featuring a four-screw design and locking cover plate, is a titanium stand-alone anterior lumbar interbody fusion system. They are available in 7˚, 12˚, 17˚, 22˚ and 28˚ lordotic angles, with various heights and footprints for proper lordosis and intervertebral height restoration, and come with advanced instrumentation that’s designed to decrease operative steps during surgery.

Festo Introduces Partially 3D Printed Bionic Robot

German company Festo, the robotics research of which we’ve covered before, has introduced its Bionic Learning Network’s latest project – three bionic robots inspired by a flic-flac spider, a flying fox, and a cuttlefish. The latter of these biomimetic robots, the BionicFinWave, is a partially 3D printed robotic fish that can autonomously maneuver its way through acrylic water-filled tubing. The project has applications in soft robotics, and could one day be developed for tasks like underwater data acquisition, inspection, and measurement.

The 15 oz robot propels itself forward and backward through the tubing using undulation forces from its longitudinal fins, while also communicating with and transmitting data to the outside world with a radio. The BionicFinWave’s lateral fins, molded from silicone, can move independently of each other and generate different wave patterns, and water-resistant pressure and ultrasound sensors help the robot register its depth and distance to the tube walls. Due to its ability to realize complex geometry, 3D printing was used to create the robot’s piston rod, joints, and crankshafts out of plastic, along with its other body elements.

Cintec Using 3D Printing on Restoration Work of the Red House

Cintec North America, a leader in the field of structural masonry retrofit strengthening, preservation, and repair, completes structural analysis and design services for projects all around the world, including the Egyptian Pyramids, Buckingham Palace, Canada’s Library of Parliament, and the White House. Now, the company is using 3D printing in its $1 million restoration project on the historic Red House, which is also known as the seat of Parliament for the Republic of Trinidad and Tobago and was built between 1844 and 1892.

After sustaining damage from a fire, the Red House, featuring signature red paint and Beaux-Arts style architecture, was refurbished in 1904. In 2007, Cintec North America was asked to advise on the required repairs to the Red House, and was given permission to install its Reinforcing Anchor System. This landmark restoration project – the first where Cintec used 3D printing for sacrificial parts – denotes an historic moment in structural engineering, because one of the reinforcement anchors inserted into the structure, measuring 120 ft, is thought to be the longest in the world.

GE Files Patent to Use Blockchains For 3D Printing Protection

According to a patent filing recently released by the US Patent and Trademark Office (USPTO), industry giant GE wants to use a blockchain to verify the 3D printed parts in its supply chain and protect itself from fakes. If a replacement part for an industrial asset is 3D printed, anyone can reproduce it, so end users can’t verify its authenticity, and if it was made with the right manufacturing media, device, and build file. In its filing, GE, which joined the Blockchain in Transport Alliance (BiTA) consortium in March, outlined a method for setting up a database that can validate, verify, and track the manufacturing process, by integrating blockchains into 3D printing.

“It would therefore be desirable to provide systems and methods for implementing a historical data record of an additive manufacturing process with verification and validation capabilities that may be integrated into additive manufacturing devices,” GE stated in the patent filing.

ExOne to Undergo Global Cost Realignment

3D printer and printed products provider ExOne has announced a global cost realignment program, in order to achieve positive earnings and cash flow in 2019. In addition to maximizing efficiency through aligning its capital resources, ExOne’s new program will be immediately reducing the company’s consulting projects and headcount – any initial employee reductions will take place principally in consulting and select personnel. The program, which has already begun, will focus first on global operations, with an emphasis on working capital initiatives, production overhead, and general and administrative spending. This program will continue over the next several quarters.

“With the essential goal of significantly improving our cash flows in 2019, we have conducted a review of our cost structure and working capital practices. We are evaluating each position and expense within our organization, with the desire to improve productivity. As a result, we made the difficult decision to eliminate certain positions within ExOne, reduce our spending on outside consultants and further rely on some of our recently instituted and more efficient processes,” explained S. Kent Rockwell, ExOne’s Chairman and CEO. “Additional cost analyses and changes to business practices to improve working capital utilization will be ongoing over the next several quarters and are expected to result in additional cost reductions and improved cash positions. All the while, we remain focused on our research and development goals and long-term revenue growth goals, which will not be impacted by these changes, as we continue to lead the market adoption of our binder jetting technology.”

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