3D Printing, Expandable Cages Popular Among Pre-NASS Product Launches

Companies got a jump on their spine product announcements well ahead of day one of the NASS Annual Meeting, this year. From September 1 to October 23 alone, we covered 45 spine-centric announcements, from funding to patents to reimbursements, etc. Here we recap just the product updates to acquaint you with what you’ll see and hear on the exhibit floor. Two trends from recent years—3D printing and expandable cages—are well represented on the list.

• 4WEB Medical launched its next-generation 3D-printed Anterior Spine Truss interbody fusion system.
• ChoiceSpine received FDA 510(k) clearance to market the HAWKEYE Ti vertebral body replacement, its first 3D-printed device.
• DePuy Synthes unveiled the VIPER PRIME™ pedicle screw. Full EMEA commercial launch is slated for early 2018.
• Expanding Orthopedics received FDA 510(k) clearance for the FLXfit™15 expandable interbody cage.
• HD LifeSciences received FDA 510(k) clearance and commenced U.S. launch of NanoHive™, a system of interbody devices for ALIF, PLIF and TLIF procedures.
• IMPLANET received FDA 510(k) clearance and the CE Mark to market JAZZ™ Passer, a system of spinal instruments and braided band technology used in posterior fixation procedures.
• K2M commenced global launch of EVEREST® Minimally Invasive XTower™ instrumentation to support the EVEREST MI XT cannulated top-loading polyaxial pedicle screw.
• K2M received FDA 510(k) clearance to market the YUKON™ OCT system to support fusion with posterior fixation in the occipito-cervico-thoracic spine.
• Life Spine commenced alpha launch of the SENTRY™ ALIF plate, designed to omit the need for posterior stabilization with anterior lumbar interbody fusion.
• Mazor Robotics received CE Mark approval for the Mazor X Surgical Assurance Platform.
• Nexxt Spine received FDA 510(k) clearance to market 3D-printed NEXXT MATRIXX™ interbody and vertebral body replacement devices.
• NuVasive launched LessRay®, hardware and software designed to minimize overexposure to radiation in the O.R., and Modulus® XLIF®, 3D-printed titanium implants for use in lateral lumbar interbody fusion.
• NuVasive received FDA 510(k) clearance for use of redesigned MAGEC® growing rods with the RELINE® Small Stature pediatric deformity fixation system. The company also received expanded FDA 510(k) clearance of the TLX™ interbody fusion system, including an expandable 20° cage, use with allogeneic bone graft and use in additional levels of the spine.
• Providence Medical Technology received FDA 510(k) clearance to market the ALLY™ Posterior Fixation system as an adjunct to fusion in the cervical spine.
• SeaSpine commenced full commercial launch of Shoreline®, its anterior cervical standalone system.
• Spinal Resources received FDA 510(k) clearance to market the Swedge™ Pedicle Screw.
• Spineology commenced full market release of the Elite™ Expandable Interbody Fusion system. More than 300 cases have been completed since limited launch in 2Q16.
• Stryker Spine received FDA 510(k) clearance to market its 3D-printed Tritanium® C Anterior Cervical Cage.
• Wenzel Spine commenced U.S. launch of revisions to its VariLift®-C standalone interbody fusion system, including new implant sizes and MIS instrumentation.
• Xtant Medical received FDA 510(k) clearance to market line extensions for the Irix-A standalone interbody spacer.
• Zimmer Biomet commenced U.S. launch of the Avenue® T TLIF Cage, featuring self-guided, curved VerteBRIDGE® plating.

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