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

GoProto Buys 3D Systems’ Australian Site, Largest 3D Printing Service in APAC Region

CERN & 3D Systems 3D Print Parts for the Large Hadron Collider



Categories

3D Design

3D Printed Art

3D Printed Food

3D Printed Guns


You May Also Like

Featured

Sugar Lab Review: Throwing a Stuffed Animal Birthday Party with 3D Printed Sugar Treats

As food 3D printing slowly congeals into the mainstream, ordinary consumers are being introduced to an increasing number of options for getting their hands on the technology—or at least the...

3D Printing Webinar and Virtual Event Roundup: November 29, 2020

While there are no more webinars for the month of November, we have plenty coming up this week when it switches to December. Topics including 3D software updates, cloud-based solutions,...

Featured

Two Lasers Can Now Work on One Part: Premium Aerotec Certifies GE Additive Metal 3D Printing for Airbus

Airbus subsidiary Premium Aerotec will use GE Additive’s newly validated multi-laser Concept Laser M2 system to produce titanium components for the Airbus A320 airliner family. An aerospace supplier, Premium Aerotec...

FDA Clears 3D Systems Patient-Specific 3D Printed Surgical Guides for Ankles

Leading additive manufacturing solutions partner 3D Systems announced that the U.S. Food and Drug Administration (FDA) has cleared the company’s 3D printed Vantage Ankle PSI (patient-specific instrumentation) surgical cutting guides....


Shop

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