Device Approvals & Patents
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FDA Clears Orthofix's OrthoNext Digital Platform for the JuniOrtho Plating System
The Plating System is designed to address the demands of advanced deformity and trauma reconstruction of the lower extremities.Michael Barbella, Managing Editor 05.10.21
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Instruments | Large Joint
FDA Clears MY01's Continuous Compartment Pressure Monitor
Aids in diagnosis of Compartment Syndrome, an orthopedic emergency.Sam Brusco, Associate Editor 05.06.21
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Extremities | Imaging
FDA OKs GSI's PreView 3D Shoulder Arthroplasty Planning Software
Develops pre-operative shoulder plans based on CT imaging studies.Sam Brusco, Associate Editor 05.06.21
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Spine/Neurology
FDA Clears Life Spine's PROLIFT Lateral HELO Fixation System
The expandable lateral spacer restores disc height.Michael Barbella, Managing Editor 05.05.21
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Spine/Neurology
FDA OKs Neurolutions' IpsiHand System for Stroke Rehabilitation
Brain-computer-interface device assists in rehab for stroke patients with upper extremity disability.Sam Brusco, Associate Editor 04.27.21
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Spine/Neurology
FDA Clears Orthofix's 3D-Printed FORZA Titanium TLIF Spacer System
The product features a large open graft window for packing bone-grafting material.Michael Barbella, Managing Editor 04.22.21
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Large Joint | MIS/Robotics
FDA OKs Zimmer Biomet's ROSA Partial Knee System
The firm earned 510(k) clearance for robotically-assisted partial knee arthroplasty.Sam Brusco, Associate Editor 04.20.21
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Spine/Neurology
FDA Approves NuVasive's Simplify Disc for Two-Level Cervical Total Disc Replacement
Implant achieved the highest overall clinical success rate at both one- and two-levels compared to any other approved cervical disc.Michael Barbella, Managing Editor 04.07.21
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Spine/Neurology
Empirical Spine's LimiFlex Device Granted Breakthrough Designation Status
Product targets degenerative spondylolisthesis.Michael Barbella, Managing Editor 04.06.21
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Spine/Neurology
FDA Clears Orthofix's 3D-Printed Titanium Cervical Spacer System
Designed with nanoscale surface features, the CONSTRUX Mini Ti System is Orthofix’s first 3D-printed titanium interbody introduced to the market.Michael Barbella, Managing Editor 04.05.21
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Spine/Neurology
Helius Medical's PoNS Approved to Treat MS-Induced Gait Problems
Neuromuscular tongue stimulator helps provide treatment of motor deficits.Sam Brusco 03.26.21
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Spine/Neurology
FDA Clears Life Spine's PROLIFT Wedge Expandable Spacer System
The device maintains coronal alignment while achieving sagittal correction.Michael Barbella, Managing Editor 03.22.21
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Extremities
Catalyst OrthoScience's Reverse Shoulder Earns FDA Nod
Catalyst intends to start limited U.S. user release in the second quarter of this year.Sam Brusco, Associate Editor 03.18.21
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Spine/Neurology
FDA Clears 4WEB Medical's Lumbar Plating Solution
Company expects to launch its hyperlordotic lateral impant line and an Anterior-to-Psoas implant by the end of the year.Michael Barbella, Managing Editor 03.18.21
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Extremities
FDA Clears Leith Medical's Foot and Ankle Plating System
The product allows micromotion to stimulate physiologic bone healing.Michael Barbella, Managing Editor 03.15.21
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HD Lifesciences Expands Patent Portfolio
The company's latest patent relates to lattice structures for interbody cages.Michael Barbella, Managing Editor 03.11.21
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Trauma/Sports
FDA OKs Able's Valkyrie Thoracic Fixation System
Fully disposable bioactive sternal plating system.Sam Brusco, Associate Editor 03.10.21
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Large Joint
Australia Clears Conformis' iTotal PS Knee Replacement System
The system's patient-specific implants fit the unique size and shape of each person’s knee.Michael Barbella, Managing Editor 03.08.21
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Extremities
FDA Approves Accufix Surgical's Accu-Joint Hemi Implant
Hemi-arthroplasty metatarsal head or phalangeal base implant for the metatarsophalangeal (MTP) joint.Sam Brusco, Associate Editor 03.02.21
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Spine/Neurology
Fusion Robotics Receives FDA Clearance for Spinal Navigation and Robotics System
The product offers clinicians greater procedural efficiency.Michael Barbella, Managing Editor 02.26.21
