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,
Products
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,
Inovedis Gains 510(k) for SINEFIX Rotator Cuff Repair
SINEFIX is a simple staple implant, which creates a flat and even contact of tendon and bone. It distributes the...
Jul 06 2023,
FDA 510(k) Recap: Innovative Surgical Planning and Navigation Tools
The latest FDA 510(k) clearances feature solutions from Formus Labs, Proprio, THINK Surgical and SMAIO with the potential to improve...
Jun 19 2023,
Artelon Gains FDA Clearance for Ligament Reinforcements
Artelon received FDA 510(k) clearance for FlexBand, FlexPatch and FlexBand Plus for ligament repair surgery in addition to tendon repairs....
Jun 12 2023,
FDA 510(k) Recap: Four Innovative Spine Fusion Devices
Four fusion devices that recently received FDA clearance came from smaller U.S. companies. ...
May 24 2023,
Paragon 28 Launches Comprehensive Supramalleolar Osteotomy System
The system includes patent pending drilling and cutting guides to facilitate repeatable and controlled anterior dome, medial opening, and closing...
May 23 2023,
Five-Year Survivorship Data for Moximed MISHA Knee
Moximed’s MISHA Knee System data supports avoidance of early arthroplasty in certain populations....
May 23 2023,