Device Approvals & Patents
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Trauma/Sports
Silver Bullet's Antimicrobial Bone Screw Wins CE Mark
OrthoFuzIon Orthopedic Bone Screw System is the world’s first regulatory-approved antimicrobial bone screw product for orthopedic procedures.Business Wire 01.10.20
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Software & Quality | Spine/Neurology
Medicrea Secures 7 New U.S. UNiD ASI Patents
The UNiD ASI software platform and UNiD LAB expert concierge services let surgeons plan cases pre-operatively.Business Wire 01.07.20
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Spine/Neurology
FDA Clears Life Spine's Titanium Stand-Alone ALIF Spacer System
The product comes in footprints of 34mm x 24mm, 38mm x 28mm, and 42mm x 30mm.Business Wire 01.07.20
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Biologics
FDA Clears DiFusion Inc.'s Xiphos ZFUZE
First-of-its-kind biomaterial poised to disrupt the PEEK and titanium implant market.Business Wire 12.17.19
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Software & Quality
FDA Approves mediCAD Hectec's Latest Product, mediCAD Web
The company is introducing a planning software into the market that provides more flexibility in the planning process.PresseBox 12.16.19
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FDA OKs First Test to Help Screen for Newborn Duchenne Muscular Dystrophy
PerkinElmer's test measures dried blood samples collected from the prick of a newborn’s heel 24 to 48 hours after birth.U.S. Food and Drug Administration 12.13.19
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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
