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NASS Preview: 14 Spine Products That Caught Our Attention

NASS is fast approaching, which means that the level of spine-related news is about to ramp up. This year, we’ve covered 43 product launches and 36 regulatory-related announcements focused on spine, many from NASS-exhibiting companies.

Use of additive/3D printing, new versions of expandable interbodies, robotics, navigation, imaging, surface coatings and textures and SI joint fusion technologies are reflected in the 14 product highlights below, and we've noted if the company isn't slated to exhibit. We expect to hear more about these companies and the technologies they're utilizing at NASS.

            EIT Cervical US Cage
            EIT Cellular Titanium Cervical Cage
             

EIT - Emerging Implant Technologies | NASS Booth 1130

EIT Cellular Titanium Cervical Cage

  • Anterior cervical interbody fusion devices used with supplemental fixation and bone graft
  • Gained expanded FDA clearance to market these devices for multiple contiguous levels
  • This is reportedly the first multi-level 3D printed cervical cage on the U.S. market. EIT entered the U.S. with first products in 4Q17. The company intends to launch a 3D-printed lateral expandable cage in 4Q18.

Of note: In September, Johnson and Johnson Medical Devices acquired EIT.

Insight Medical Systems | Not exhibiting

ARVIS Augmented Reality Navigation

  • Announced plans for a 2019 launch for application in spinal fusion (as well as joint recon and ACL repair)
  • Intended as an alternative to large and more costly surgical robots and navigation systems, features a headset that projects virtual models of the patient’s anatomy into the surgeon’s field of view during the procedure, revealing structures beneath the surface
  • Visualization includes models of implants and instruments in relation to interior anatomy, with a display of measurements associated with orientation and positioning

K2M | NASS Booths 2001, 2705

BACS Patient-Specific devices

  • Received FDA 510(k) clearance
  • This fifth module in the BACS platform allows for the creation of pre-contoured rods, rails and templates, and is the company’s first patient-specific indication
  • A machine rolling manufacturing method avoids rod fatigue that may incur with manual, 3-point bending. When used with data from the BACS Surgical Planner, rods and rails can be shaped into complex multi-contoured designs.

MOJAVE PL 3D Expandable Interbody

  • Launched in the U.S.; features Lamellar 3D Titanium Technology to enable bony integration
  • Reportedly the first 3D-printed expandable posterior lumbar interbody on the market

Of note: In August, Stryker announced its intent to acquire K2M by end of year.

Medicrea | NASS Booth 1823

UNiD Patient Specific 3D Printed Cage

  • Obtained what is reportedly the first FDA 510(k) clearance to market patient-specific spinal cages
  • Using the UNiD artificial intelligence-driven ASI platform (Adaptive Spine Intelligence) , the company can now support digital planning, in-house manufacture and supply of devices from its IB3D line of 3D-printed titanium interbody devices
  • IB3D is designed as an alternative to the surgeon testing among available sizes to select an implant that will suit the patient (but which lacks optimization)
            medtronic tionic
            Medtronic TiONIC
             

Medtronic | NASS Booths 2601, 2701

TiONIC, a new 3D-printed titanium technology

  • Launched to support complex designs and integrated surface technologies for spine implants
  • ARTiC-L for transforaminal lumbar interbody fusion is the first to be manufactured with the TiONIC laser-based technique
  • ARTiC-L is inserted and positioned using just one instrument, and offers lordotic angles up to 20 degrees

Nanovis | NASS Booth 2260

FortiCore interbody fusion with a differentiated surface

  • Gained FDA 510(k) clearance to market devices that feature a Nanosurface-enhanced porous titanium scaffold, intermolded with a PEEK core, for use in TLIF and ALIF
  • The nanopatterned surface targets fixation-related complications; it also forms the basis of a bactericidal program under development to address infection-related complications

NuVasive | NASS Booths 2301, 2603, 2605

Pulse surgical automation, foundation for Surgical Intelligence

  • Received FDA 510(k) clearance
  • Debuts 2D and 3D navigation components and smart imaging capabilities, and integrates neuromonitoring, surgical planning, radiation reduction and patient-specific rod bending technologies
  • Can be used at all facilities, from major health systems to ASCs
  • Will be integrated with Siemens Healthineers’ Cios Spin mobile 3D C-arm through a Spine Precision Partnership

Paradigm Spine | NASS Booth 1429

coflex Interlaminar Stabilization disposable instrument kit

  • Granted supplemental FDA PMA, marking the first approved disposable spinal instrument set for a Class III spinal device to receive a supplemental PMA
  • Kit will include a complete set of injection molded instruments delivered in a pre-sterilized peel pack, especially ideal for outpatient/ambulatory care settings

Providence Medical Technology | NASS Booth 1535

DTRAX Spinal System

  • Gained FDA 510(k) clearance to market the system for use in posterior cervical fusion in patients with degenerative disc disease
  • 510(k) provides a more specific indication for DTRAX, which was a Class I device with a broad indication for fusion.
  • DTRAX is reportedly the only sterile-packaged, single-use set of instruments specifically cleared for posterior cervical fusion
            RTIX Fortilink C
            RTI Surgical Fortilink
             

RTI Surgical | NASS Booth 1523

Fortilink-TS and -L lumbar interbody fusion

  • Launched these systems, which feature TETRAfuse 3D printed polymer
  • Fortilink-L is reportedly the first osteointegrative, radiolucent cage on the market
  • TETRAfuse 3D features a nano-rough surface with antibacterial characteristics and is designed to support fusion without compromising mechanical integrity or radiographic visibility

Tenon Medical | Not exhibiting

Catamaran Sacroiliac Joint Fixation

  • FDA 510(k) clearance, indicated for sacroiliac joint fusion to treat sacroiliac joint disruptions and degenerative sacroilitis
  • Reportedly the first patented single implant SIJ fusion system to employ a posterior approach for minimal tissue disruption

Vallum | Not exhibiting

Peekplus Interbody Fusion Device

  • FDA 510(k) clearance for this PEEK interbody fusion device with a PEEKplus nanotextured surface
  • Created with proprietary Accelerated Neutral Atom Beam technology
  • Reportedly represents the first FDA-cleared nanotextured surface on a PEEK interbody

Zimmer Biomet | NASS Booth 1713

Zyston Strut Open Titanium Interbody Spacer

  • FDA 510(k) clearance for the company’s first titanium spinal implant manufactured via 3D printing
  • Zyston comprises a family of lumbar cages designed to enhance strength, graft capacity and visualization of the spacer, sized for a range of anatomies and surgical approaches
  • Includes instruments for insertion, manipulation and implant removal

Sources: Company press releases, websites, FDA.gov, information in the public domain; Images courtesy of manufacturers



Julie A. Vetalice is ORTHOWORLD’s Editorial Assistant. Reach her by email.

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