Device Approvals & Patents
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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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Large Joint
FDA OKs First Test to Help Detect Prosthetic Joint Infections
Synovasure Lateral Flow Test Kit aids in the detection of infection in the synovial fluid of patients being evaluated for revision surgery.U.S. Food and Drug Administration 05.24.19
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Trauma/Sports
FDA OKs AMDT Holdings' SixFix Hexapod Fixator Device
External fixator shortens surgical time, simplifies inventory, and enhances patient care.PR Newswire 05.15.19
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Extremities
FDA Clears Lapiplasty 3D Bunion Correction System for Pediatric Patients
New indication provides surgeons the ability to treat adolescent patients with the Lapiplasty System.Business Wire 05.06.19
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Spine/Neurology
SI-BONE's iFuse Bedrock Spinopelvic Fixation Technology Gains Additional FDA Nod
The company's iFuse Bedrock technology was cleared for fusion of the sacroiliac (SI) joint during long construct procedures.GlobeNewswire 04.15.19
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Imaging | Software & Quality
FDA OKs Scientific Analytics' Computer-Vision-Powered Motion Analysis Technology
The company also formed a strategic collaboration with Hospital for Special Surgery, which has been ranked #1 in orthopedics for the past 9 years.PR Newswire 04.04.19
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Spine/Neurology
Intellirod Spine Receives First Ever Spine FDA De Novo Approval
The company received approval for its revolutionary disposable spinal rod strain sensor, the LOADPRO.Business Wire 04.02.19
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WINDGO Granted Responsive Biomechanical Implants and Devices Patent
Company's joint implant system has applications both inside and outside the body.PR Newswire 04.02.19
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Spine/Neurology
SpineEX Gains Patent for Expandable and Adjustable Lordosis Interbody Fusion System
The patent covers a novel mechanism that allows surgeons to adjust the posterior and anterior sides of an interbody fusion device independently of one another.GlobeNewswire 03.29.19
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Spine/Neurology
SpineEX Gains Additional FDA Nod for Sagittae Lateral Lumbar Interbody Fusion System
This additional 510(k) clearance will enhance SpineEX’s ability to achieve full-scale commercialization.GlobeNewswire 03.25.19
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MIS/Robotics | Spine/Neurology
FDA OKs Zimmer Biomet's ROSA ONE Spine System for Robotically-Assisted Surgeries
Zimmer Biomet becomes the first company in the world with 510(k) clearance for brain, spine, and knee offerings on one robotic platform.PR Newswire 03.25.19
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Large Joint
Exactech's Acetabular Implant Featuring Vitamin E Technology Wins FDA Nod
The company received 510(k) clearance for Alteon Cup and XLE Liner.Business Wire 03.15.19
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Extremities
AAOS News: FDA OKs Catalyst OrthoScience's Uncemented Press Fit Humeral Component
Press fit humeral implant features non-spherical anatomic head.Business Wire 03.14.19
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Extremities | Materials
AAOS News: Nvision Launches First Foot & Ankle Implant Made from PEEK-OPTIMA HA Enhanced
Implant from Nvision corrects hammertoe and expands product offering to lower extremities.Invibio Biomaterial Solutions 03.12.19
