Device Approvals & Patents
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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
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Extremities
FDA OKs FX's Easytech Stemless Anatomic Shoulder Replacement
Only stemless shoulder prosthesis on the market with primary peripheral fixation, according to the company.Sam Brusco, Associate Editor 02.19.21
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Spine/Neurology
Camber Spine Expands Patent Portfolio With SPIRA Lateral 3.0
The implant is a titanium open architecture LLIF utilizing the company's Surface by Design technology.Michael Barbella, Managing Editor 02.10.21
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Robotic Laser Bone-Cutting Technology Approved in Europe
A laser beam removes the bone precisely in layers, leaving no residue.Michael Barbella, Managing Editor 02.09.21
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FDA Clears Longeviti's Reconstructive Cranial Implant
The product allows for ultrasound imaging after surgery.Michael Barbella, Managing Editor 02.04.21
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Osteoporosis Prevention Product Wins FDA Breakthrough Device Designation
The product has been shown in studies to reduce bone loss activity.Michael Barbella, Managing Editor 02.02.21
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FDA Clears Method to Extract Bone Measurements From X-Rays
The solution addresses the logistical bottleneck spurred by unnecessary implants being delivered to each surgery.Michael Barbella, Managing Editor 01.27.21
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Biologics
FDA Breakthrough Device Designation Granted to Spiderwort's Spinal Cord Technology
Company's biomaterial uses a plant-based cellulose scaffolding to create a framework that supports the regeneration of healthy tissues.Spiderwort Inc. 01.20.21
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Large Joint
DePuy Synthes Receives 510(k) FDA Clearance for VELYS Robotic-Assisted Solution
The system is designed for use with the company's ATTUNE Total Knee System.PR Newswire 01.19.21
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Extremities
FDA Clears Nvision Biomedical's Osteotomy Wedge System
Growing product portfolio for lower extremities made of innovative bone on-growth biomaterial.Nvision Biomedical Technologies 01.12.21
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Spine/Neurology
CTL Amedica Secures U.S. Patent for Articulating Implant Insertion System
The device allows for minimum tissue disruption, controlled re-positioning, and more efficient deployment of compatible, curved TLIF cages.CTL Amedica 01.07.21
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FDA Clears Use of Navigated Interbody, Midas Rex Drills with Medtronic's Mazor System
Broader functionality includes enhanced visualization of tools, greater access and interbody navigation to streamline hospital workflows.PR Newswire 12.16.20
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Spine/Neurology
U.S. Patent Granted for Posterior SI Joint Fusion Surgery Site Preparation
The TransFasten technique is intended to provide stabilization of the SI joint.PR Web 12.09.20
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Spine/Neurology
FDA Clears NuVasive's Thoracolumbar Portfolio for Sagittal Deformity Treatment
The clearance expands the portfolio's indications from one- to two-level spine surgery, to now multiple levels.PR Newswire 11.09.20
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Extremities
FH Ortho Unveils e-Ortho Planification Software
The software provides shoulder replacement surgeons with a web-based platform to assist in preoperative surgical technique planning.Globe Newswire 10.05.20
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Spine/Neurology
Orthofix FIREBIRD SI Fusion System Receives Additional FDA Clearance for Nanotechnology
The system enables surgeons to pack the device with autograft and/or allografts to help promote bone fusion.Business Wire 10.01.20
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Extremities
Carbon22 Receives FDA 510(k) Clearance for FusionFrame Ring Lock System
The Consortium-designed circular external fixator can treat complex foot/ankle deformities and provide a static frame for various indications.EINPresswire 09.30.20
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Spine/Neurology
FDA Clears Life Spine's SI Joint Revision Offering
Additional claims for the SImpact Sacroiliac Joint Fixation System were also cleared.Business Wire 09.23.20
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Spine/Neurology
CTL Amedica Receives TFDA License for Three Silicon Nitride Spine Products
The Valeo product line is projected to commercialize later this year in Taiwan.CTL Amedica Corporation 09.11.20
