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

Share this Article

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.

What do you think? Discuss this story and other 3D printing topics at 3DPrintBoard.com or share your thoughts in the Facebook comments below. 

[Images: Nexxt Spine]

Share this Article


Recent News

Enabling the Future: 3D Printed Frog Arm Prosthetic for Epilepsy Patients

Promoting Additive Manufacturing: GE Additive Lichtenfels Facility Opening Celebrated in Bavaria



Categories

3D Design

3D Printed Art

3D Printed Food

3D Printed Guns


You May Also Like

Titomic Signs Agreement & MoU with GE Additive Company AP&C for Titanium 3D Printing Powder

It hardly seems possible that it’s now been two years since Australian metal 3D printing company Titomic unveiled its patented, innovative Titomic Kinetic Fusion (TKF) process, which is adapted from...

Arcam EBM Center of Excellence: GE Additive Expands Additive Manufacturing Site by Three Times

If you had any questions regarding a potential slow down in 3D printing or additive manufacturing endeavors around the world, industry leaders like GE Additive should put those to rest,...

3D Printing News Briefs: August 16, 2019

In today’s 3D Printing News Briefs, we’re starting with some business and ending with an upcoming event. The Rapid Application Group has earned an important industry certification, and GE Additive...

Bralco and GE Additive Sign MoU for Increased Development of 3D Printed Magnetic Components in APAC Region

Singapore-based metal Bralco Advanced Materials, a research, product development, and commercialization company specializing in metal 3D printing, just announced that it has signed a Memorandum of Understanding (MoU) with GE...


Shop

View our broad assortment of in house and third party products.


Print Services

Subscribe To Our Newsletter

Subscribe To Our Newsletter

Join our mailing list to receive the latest news and updates from our 3DPrint.com.

You have Successfully Subscribed!