ZKR Orthopedics Granted FDA Breakthrough Device Designation
ZKR's LIFT implant is designed to decrease pain, improve function and delay or eliminate the need for knee replacement....
Oct 12 2023,
Products
FDA Clears Intelivation Technologies’ Hammerdesis Interphalangeal Fusion
Hammerdesis corrects hammertoe issues in by affixing a distinctively designed implant on the patient's toe joint....
Oct 11 2023,
OnPoint Surgical Gains 510(k) for Augmented Reality Spine System
The OnPoint AR Spine System superimposes virtual surgical guides and virtual implants onto the surgeon's visual field using see-through optical...
Oct 11 2023,
ChoiceSpine Gains Standalone Indication for Blackhawk Spacer
Blackhawk Ti employs preassembled integrated anchor technology with a cam-locking mechanism and features the BioBond 3D-Printed Titanium porous structure....
Oct 11 2023,
FDA Grants Second Breakthrough Device Designation to Carlsmed
This complements the company’s family of lumbar patient-specific interbody fusion devices for anterior, lateral and transforaminal approaches....
Oct 11 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...
Oct 11 2023,
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,
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,