DePuy Synthes Receives FDA Clearance for TriALTIS Spine System and Navigated Instruments
DePuy Synthes secured 510(k) clearances from FDA for the TriALTIS Spine System and for TriALTIS Navigation Enabled Instruments....
Oct 09 2023,
Products
FDA 510(k) Recap: Improvements in Fracture Fixation and New Solutions for Spine
This month’s roundup features FDA 510(k) clearances for versatile and stable spine fusions, fracture fixation in pediatric patients and new...
Sep 27 2023,
ZimVie Announces FDA Approval to Launch Mobi-C Hybrid Study
The decision clears the way for enrollment of U.S. patients in a clinical study of cervical arthroplasty adjacent to fusion....
Sep 26 2023,
Exactech Gains 510(k) for Activit-E Polyethylene in Ankle Replacement
Activit-E is a next-generation highly crosslinked polyethylene with vitamin E antioxidant stabilization....
Sep 21 2023,
Treace Medical Concepts Grows Bunion Treatment Offerings
These products will be available in limited U.S. market release through Treace’s bunion-focused sales team, with full market launch slated...
Sep 12 2023,
Orthofix Launches 7D FLASH Navigation Percutaneous Module 2.0
The system uses visible light to create a 3-dimensional image for surgical navigation in seconds, enabling faster and more efficient...
Aug 28 2023,
FDA 510(k) Recap: Outpatient Knee Revision Surgery, Advanced Augmented Reality and More
Devices for minimally invasive fracture fixation and stronger rotator cuff repairs join an innovative augmented reality system in the new...
Aug 22 2023,
Exactech Receives FDA Clearance for Advanced Activit-E Knee Replacement Polyethylene
Activit-E brings a balance of material strength and toughness through chemically crosslinked polyethylene, and eliminates the need for gamma irradiation....
Aug 21 2023,
ZimVie Gains FDA Approval for New Mobi-C Implant
FDA approved a smaller height of Mobi-C in seven footprints to address the anatomical needs of the U.S. patient population....
Aug 10 2023,
Axial3D Gains 510(k) for INSIGHT Medical Image Segmentation
The cloud-based solution supports personalized healthcare through scalable, personalized 3D solutions driven by artificial intelligence....
Jul 31 2023,
Globus Medical Launches MARVEL Growing Rod System
MARVEL Growing Rods are designed for pediatric patients with early onset scoliosis to obtain and maintain correction while allowing for...
Jul 31 2023,
FDA 510(k) Clearance for Bone Bolt Fracture Repair System
Bone Bolt implants are used to treat challenging bone fractures, such as pelvic fractures and fractures of the long bones...
Jul 31 2023,
FDA 510(k) Recap: New Solutions for Spine and Shoulder Surgeries
This month’s roundup includes a new shoulder replacement, a company’s first sacroiliac joint implant, a novel device for rotator cuff...
Jul 25 2023,
NextStep Arthropedix Launches Retractorless Approach
The Preserve by NextStep is a retractorless, assistantless anterior hip approach that avoids soft tissue and bone injury caused by...
Jul 18 2023,
First Cases with Tetrous EnFix RC Implant
The first four surgical cases with the EnFix RC implant offer surgeons a solution for inadequate healing at the tendon/bone...
Jul 18 2023,