Centinel Spine Announces FDA Approval for Two-level prodisc L Total Disc Replacement

Centinel Spine LLC prodisc L Total Disc Replacement

Centinel Spine®, LLC, the largest privately-held spine company focused on anterior column reconstruction, today announced FDA approval of two-level indications for the prodisc® L Lumbar Total Disc Replacement (TDR) system. Centinel Spine now becomes the only company in the world with an FDA-approved lumbar TDR device that has been clinically reviewed and found safe and effective for…

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Precision Spine Announces the Worldwide Launch of the Reform Ti Pedicle Screw System Providing Surgeons with Increased Flexibility, Versatility, and Visibility 

Precision Spine Logo

Precision Spine, Inc., a medical device company dedicated to Made-in-the-USA manufacturing, has launched world wide the Reform® Ti Titanium Pedicle Screw System, which provides surgeons with the increased flexibility, versatility, and visibility that is required during today’s challenging degenerative and trauma spine procedures. The Reform Ti System features a titanium tulip and a triple lead thread to…

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Orthofix Completes Acquisition of FITBONE Limb Lengthening System 

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Orthofix Medical Inc., a global medical device company focused on musculoskeletal healing products, today announced it has completed the acquisition of assets associated with the FITBONE® intramedullary lengthening system for limb lengthening of the femur and tibia bones. The transaction also includes other potential applications of the technology which are in development, including the FITSPINE® system for…

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OSSIO Receives FDA 510(k) Clearance for OSSIOfiber Hammertoe Fixation System 

OSSIOfiber

OSSIO, Inc., an orthopedic fixation company, today announced that its OSSIOfiber® Hammertoe Fixation System has received 510(k) market clearance from the U.S. Food and Drug Administration (FDA) for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodesis and bone grafts. These novel bio-integrative implants with disposable, sterile instrumentation now come in three sizes, with…

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TriMed, Inc. Announces Release of the ASET™ Foot Plating Systems 

TriMed-Blue_logo

TriMed, Inc. an orthopaedic medical device developer and manufacturer focused on extremities, announced it would begin marketing its new ASET™ Foot Plating System. The ASET Foot Plating System, designed to treat common forefoot and mid-foot indications, offers unique implants to treat MTP fusions, Lapidus fusions, and TMT fusions. In addition, the system’s variety of patented…

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CrossRoads Extremity Systems, LLC Announces Launch of the HiMax Plus Widebody Fixation System for Foot Fusions

CrossRoads® Extremity Systems, the global leader in Staple Compression Plates(SCP) and nitinol technology for the lower extremities, announced it has received FDA clearance and launched the HiMax® Plus Widebody Fixation System. HiMax® Plus is the only foot bone fusion system on the market to provide flush insertion, market leading compression, and a wide bridge for enhanced stability. The features work…

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MEDICREA Announces FDA Clearance of the World’s First Patient-Matched Spinal Interbody Cages

ASI

MEDICREA® (Euronext Growth Paris : FR0004178572 – ALMED, PEA-PME eligible and OTCQX : MRNTF), pioneering the transformation of spinal surgery through Artificial Intelligence, predictive modeling and patient specific implants with its UNiD® ASI (Adaptive Spine Intelligence) proprietary software platform, concierge expert services and technologies, announced today that it has received FDA-Clearance for UNiD® IB3D Patient-Matched interbody cages which…

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In2Bones Receives FDA 510(k) Clearance for Quantum Total Ankle 

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In2Bones Global, Inc. today announces clearance from the U.S. Food and Drug Administration to market the Quantum™ Total Ankle. This new total ankle replacement system treats patients who suffer from arthritis and is designed to improve patient mobility, increase stability, and technologically advance implant placement based on patient-specific anatomy. Compared to current total ankles on the…

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CoreLink Surpasses 5,000 Implants With Proprietary 3D Printed Technology 

Cancellous_Bone_Mimetic_Metal_CoreLink

CoreLink, LLC, a leading designer and manufacturer of spinal implant systems, today announced the implantation of over 5,000 3D printed devices using their proprietary Mimetic Metal® technology. Mimetic Metal is an additively manufactured technology that combines a lattice framework and inner trabecular pores to emulate the structural, functional and physiological properties of bone. The unique dynamic design…

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Intralink-Spine, Inc: Announces Continuation of CLBP Clinical Study 

Intralink-Spine Logo

Intralink-Spine, Inc. (ILS) announces that it has received unanimous approval from the Data Safety Monitoring Board (DSMB) to proceed with the Réjuve® clinical safety study (GEM-SE) for chronic low back pain (CLBP). As a result, ILS will be adding new sites to broaden Principal Investigator (PI) and participant representation in Australia. “After careful review of…

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