Device Approvals & Patents
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Extremities
FDA OKs Shoulder Innovations' Augmented Glenoids for Total Shoulder System
The new InSet Plus glenoids feature an angled articular surface.PR Newswire 12.10.19
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Extremities | Software & Quality
FDA OKs Shoulder Surgery 3D Planner & Positioner
Intuitive, surgeon-driven software provides 3D pre-operative planning and 3D positioners for intra-operative positioning.PR Newswire 12.10.19
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BioPrax Biofilm Disruption Device Granted FDA Breakthrough Device Designation
Product is designed to help eliminate biofilm infections on prosthetic knee implants during early intervention procedures.PR Newswire 12.09.19
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Large Joint
mediCAD is Now Officially a Medical Device in Japan
The product is an orthopedic planning solution for hip, knee, shoulder, hand, leg, or spine surgery.mediCAD Hectec GmbH 12.02.19
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Spine/Neurology
FDA Clears Expanded Multi-Level Use of NuVasive's CoRoent Small Interlock System
The product is an anterior cervical interbody fusion system for use in adult patients with cervical disc degeneration and/or cervical spinal instability.PR Newswire 11.22.19
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Biologics | Spine/Neurology
FDA Approval of Cerapedics’ Bone Graft PMA Supplement
i-FACTOR Peptide Enhanced Bone Graft continues to demonstrate statistical superiority to autologous bone in cervical spine surgery.Cerapedics 11.19.19
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Large Joint
Conformis Launches Next-Gen Hip System
The Conformis Hip System uses proprietary advanced imaging and design software to deliver a patient-specific pre-operative surgical plan.GlobeNewswire 11.11.19
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Spine/Neurology
FDA Clears SAHARA Lateral 3D Expandable Interbody System From Stryker
SAHARA Lateral is the first ever 3D-printed lateral expandable fusion device, according to the company.PR Newswire 11.04.19
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Spine/Neurology
FDA Clears Viseon's Advanced High-Definition Real Time Imaging Technology for MIS Spine Surgery
The company's Voyant technology is designed for use in both posterior and lateral access MIS spine procedures.Business Wire 11.01.19
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Spine/Neurology
Saluda Medical Launches Spinal Cord Stimulation System in Europe
The world’s first commercial implants were completed in The Netherlands.Saluda Medical 10.31.19
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Large Joint
FDA Clears Implanet's MADISON Total Knee Prosthesis
Robust clinical results, including data collected over seven years and 17,000 implants, supported the clearance.Business Wire 10.29.19
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Spine/Neurology
Japanese Regulators Approve Safe Orthopaedics' SteriSpine LC and CC
The first surgeries are planned for November.Business Wire 10.25.19
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Biologics
Nanotechnology Designation Awarded to Nanovis for Bioceramic Nanotube Surface
Company plans to apply technology to entire spinal portfolio.PR Web 10.24.19
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Spine/Neurology | Trauma/Sports
FDA OKs CarboFix's Carbon Fiber Vertebral Body Replacement System
The product was officially launched during the Congress of Neurological Surgeons (CNS).PR Newswire 10.17.19
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Spine/Neurology
FDA Clears Omnia Medical's PEEK-Optima HA Cervical Vertebral Body Replacement
Product offers the potential to improve bone apposition and patient outcomes.Omnia Medical LLC 10.17.19
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Spine/Neurology
FDA Grants 510(k) Clearance to 4WEB Medical's Cervical Stand-Alone Interbody Fusion Device
Company expands implant portfolio with the addition of the Cervical Spine Truss System - Stand-Alone.PR Newswire 10.15.19
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3-D Printing/Additive Mfg. | Instruments
FDA OKs OssDsign's Cranial PSI Accessories
The 3D-printed, patient-specific accessory devices support the company's FDA cleared cranioplasty implant.PR Newswire 10.14.19
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PAVmed is Granted a U.S. Patent Covering its CarpX Device
CarpX is designed to closely mimic the anatomic results of invasive carpal tunnel surgery, but much less invasively.Globe Newswire 10.14.19
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Large Joint | MIS/Robotics
FDA OKs THINK Surgical's Active Robot for Total Knee Replacement
Approval follows multi-center investigational clinical trial evaluating the safety and efficacy of TSolution One Total Knee Application.PR Newswire 10.10.19
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Spine/Neurology
FDA OKs Life Spine's Hinged Laminoplasty System
The laminoplasty procedure is an alternative to a laminectomy.Business Wire 09.26.19
