Device Approvals & Patents
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Extremities
FDA Clears First Pediatric-Specific Foot System
OrthoPediatrics' PediFoot Deformity Correction System treats fractures and deformities of the foot and ankle.GlobeNewswire 08.19.19
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Spine/Neurology
FDA OKs First Device to Treat Pediatric Progressive Idiopathic Scoliosis
As a patient grows, Zimmer Biomet Spine's The Tether – Vertebral Body Tethering System corrects curvature while maintaining a fuller range of motion.U.S. Food and Drug Administration 08.16.19
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Spine/Neurology
MEDICREA Secures Several New Patents to Protect its UNiD ASI Technology
The new patents are directed to fundamental technologies and methods embedded in the UNiD ASI platform.Business Wire 08.09.19
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3-D Printing/Additive Mfg. | Spine/Neurology
Nexxt Spine Adds Stand Alone Cervical to NEXXT MATRIXX Family
Anticipated line extension of leading spinal device company available for pre-order.Business Wire 08.06.19
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Spine/Neurology
FDA OKs Medicrea's TULIP GENESIS, Completing Its UNiD ASI Platform Technology
TULIP GENESIS is a top-loading screw system.Business Wire 08.02.19
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Spine/Neurology
FDA OKs Life Spine's 8-10mm Width PROLIFT Expandable Spacers
The new sizes will more than double the company's current footprint options for the PROLIFT system.Business Wire 07.25.19
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Trauma/Sports
FDA OKs OrthoPediatrics' Next-Gen Cannulated Screw System
This enhanced system offers an “all-in-one” kit option and is optimized to increase operating room efficiency.GlobeNewswire 07.24.19
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Imaging | Software & Quality | Spine/Neurology
FDA OKs MiRus' GALILEO Spine Alignment Monitoring System
GALILEO is the first system for dynamic intra-operative measurement of segmental and global spine alignment.PR Newswire 07.23.19
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Biologics
OssDsign AB Further Strengthens its Patent Portfolio
Newest additions are related to the company's material technology and implant design.OssDsign AB 07.22.19
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Imaging | Instruments
FDA OKs Integrated Endoscopy's Single-Use, HD, Battery Operated Arthroscope
Breakthrough, single-use endoscope technology approved for arthroscopic surgical procedures.Business Wire 07.18.19
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Spine/Neurology
FDA OKs Erchonia's FX 635 Laser for Chronic Musculoskeletal Pain Relief
The FX 635 low-level laser offers temporary relief of chronic, nociceptive musculoskeletal pain.PR Newswire 07.17.19
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MIS/Robotics | Spine/Neurology
FDA OKs icotec's VADERone Pedicle Screw System
VADERone is made from icotec's unique BlackArmor Carbon/PEEK material.PR Newswire 07.09.19
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MIS/Robotics | Spine/Neurology
FDA OKs Benvenue Medical's Luna XD MIS Expandable Interbody Device
New device is offered as part of a lumbar fusion solution suite that also includes Orbit Discectomy Instruments.Business Wire 06.28.19
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MIS/Robotics | Spine/Neurology
FDA OKs Life Spine's PROLIFT Lateral Expandable Spacer System
The system features minimal insertion height and controlled, in situ expansion, which are critical components in a MIS Expandable Lateral Interbody Fusion.Business Wire 06.19.19
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Spine/Neurology
Zavation Gains FDA Clearance for the Ti3Z Interbody System
Company will launch the product immediately to the U.S. market.PR Newswire 06.05.19
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MIS/Robotics | Spine/Neurology | Trauma/Sports
FDA OKs First Soft Robotic System for Stroke Therapy
ReWalk's ReStore exo-suit is a versatile, affordable medical device for U.S. rehab clinics to treat millions with gait impairment.PR Newswire 06.05.19
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Instruments | MIS/Robotics
FDA OKs Misonix's Integrated Ultrasonic Surgical Platform
Misonix will commence the commercialization of the Nexus platform in the United States in July.GlobeNewswire 06.03.19
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Biologics
FDA OKs EpiBone to Begin First-In-Human, Phase 1/2 Trial of Stem Cell-Derived Bone Graft
EB-CMF is a living anatomically correct bone graft manufactured from a patient's own adipose-derived stem cells.PR Newswire 05.29.19
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MIS/Robotics
TransEnterix Receives Japanese Regulatory Approval of the Senhance Surgical System
The product was approved for use in laparoscopy for general surgery, gynecology, urology, and certain thoracic procedures.Business Wire 05.29.19
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Kelyniam Global's Integrated Fixation System for Custom Skull Implants Gains FDA Nod
The approval covers unique modifications to their PEEK cranio-maxillofacial implant product line.PR Newswire 05.24.19
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