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Spine/Neurology
icotec Earns FDA Nod for Ø 4.5mm VADER Pedicle Screws
Made from the firm’s proprietary BlackArmor carbon/PEEK composite material.Sam Brusco, Associate Editor 01.24.23
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Spine/Neurology
NeuroMetrix Releases DPNCheck 2.0 Point-of-Care Tool
Fast, accurate, quantitative screening test for peripheral neuropathy.Sam Brusco, Associate Editor 01.23.23
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Spine/Neurology
FDA OKs VySpine's LumiVy Lumbar IBF with NanoVy Ti
Indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine, from L2 to S1.Sam Brusco, Associate Editor 01.17.23
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Large Joint
FDA Clears Episealer Patellofemoral System
The system features two opposing implants, and is intended for patients with osteoarthritis in the distal patellofemoral joint.Michael Barbella, Managing Editor 01.03.23
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Spine/Neurology
New Indications Granted for SI-BONE's iFuse Bedrock Granite Implant
Company introduced iFuse Bedrock Granite in May last year to help improve surgical outcomes.Michael Barbella, Managing Editor 01.02.23
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Spine/Neurology
Abbott Gains FDA Nod for Eterna Spinal Cord Stimulator
World's smallest implantable, rechargeable spinal cord stimulation system for chronic pain, according to Abbott.Sam Brusco 12.19.22
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Spine/Neurology
FDA OKs Life Spine's TruLift Lateral Expandable Spacer and Plates
Uses expandable tech and robust plating options to provide unique possibilities for patient care.Sam Brusco, Associate Editor 12.14.22
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Extremities | Instruments
FDA OKs Enovis' Patient-Specific Instrumentation for STAR Ankle
The STAR PSI system offers a personalized pre-operative plan.Sam Brusco, Associate Editor 12.02.22
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Extremities
Treace Medical's SpeedPlate Rapid Compression Implant Gains FDA Nod
Rapid compression implant system for fracture fixation, osteotomy fixation, and joint arthrodesis of the foot and ankle.Sam Brusco, Associate Editor 11.29.22
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FDA OKs NanoVibronix's PainShield Plus
PainShield Plus uses ultrasound therapy to treat pain and various soft tissue injuries.Sam Brusco, Associate Editor 11.29.22
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Large Joint
FDA Clears Zimmer Biomet's Persona OsseoTi Keel Tibia for Cementless Knee Replacement
New porous iteration of anatomic keeled tibia designed to deliver stable initial and biological fixation.Michael Barbella, Managing Editor 11.21.22
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MIS/Robotics
Neocis' Yomi Surgical Robot OK'ed for Bone Reduction
Enables clinicians to use the Yomi platform for more phases of full-arch rehabilitation.Sam Brusco, Associate Editor 11.15.22
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Imaging
FDA OKs Xironetic's IntraOpVSP AR Surgical Software
Current, planned use cases expected for ortho, craniofacial/maxillofacial, neuro general, plastic, thoracic, and vascular surgeries.Sam Brusco, Associate Editor 11.14.22
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Extremities | Software & Quality
Exactech Granted New Patent for Predict+
Describes a method and system to predict outcomes following arthroplasty procedures.Sam Brusco, Associate Editor 11.09.22
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Trauma/Sports
CurvaFix IM 7.5mm Implant Gains FDA OK for Pelvic Fractures
The system aims to simplify pelvic fracture fixation surgery with a fast, easy, repeatable, minimally invasive procedure.Sam Brusco, Associate Editor 11.01.22
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Spine/Neurology
FDA Clears DePuy Synthes' ALTALYNE Ultra Alignment System
The System delivers greater bending yield strength in a lower profile through advanced material science.Michael Barbella, Managing Editor 10.24.22
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FDA Clears DePuy Synthes' TELIGEN System
The platform delivers advanced visualization and user-centric procedural control.Michael Barbella, Managing Editor 10.20.22
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3-D Printing/Additive Mfg. | Spine/Neurology
FDA OKs ulrich medical USA's 3D-Printed Flux-C Cervical Interbody
Flux-C is made via direct metal laser sintering.Sam Brusco, Associate Editor 10.14.22
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Spine/Neurology
Nevro's AI-Enabled HFX iQ SCS Gains FDA Nod
Spinal cord stimulation (SCS) system learns from patients to address pain variability.Sam Brusco, Associate Editor 10.14.22
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Spine/Neurology
NASS News: OsteoCentric Gains 2 New FDA Nods
OstroCentric Pedicle Screw Fastener System with proprietary UnifiMI tech and the Integrity-SI Fusion System with indications in trauma surgery.Sam Brusco 10.11.22
