FDA 510(k) Recap: Joint Replacement Updates and Line Extensions
To date in 2020, joint replacement players like Arthrex, Conformis, DePuy Synthes, Medacta, Zimmer Biomet and others have gained FDA...
Apr 21 2020,
Products
OrthoSensor Gains 510(k) Alignment Clearance for VERASENSE for use with Zimmer Biomet’s Persona Knee
VERASENSE is a sensor-assisted device used with leading knee implant systems during primary and revision total knee procedures....
Apr 20 2020,
FDA Approves Centinel Spine’s Two-Level prodisc L for Total Disc Replacement
prodisc L is the only total disc replacement system in the U.S. approved for two-level use in the lumbar spine....
Apr 17 2020,
New Product Challenge Calls on Orthopedic Community for Ideas
Due to COVID-19, the orthopedic industry has experienced the cancellation of surgeries and therapies. As a result, patients must endure...
Apr 01 2020,
Extremity Medical Gains FDA Clearance for KinematX Total Wrist
The device is specifically designed to negate common risks of radial implants, such as limited range of motion, subluxation, distal...
Mar 30 2020,
DePuy Synthes Announces CE Mark for BI-MENTUM Dual Mobility Hip
Currently available in the U.S., BI-MENTUM is slated to enter European markets in April 2020. The system complements other hip...
Mar 24 2020,
Fusion Robotics Goes Small with 4-Pound Robot
Fusion Robotics seeks to introduce the world’s first portable spinal robotic navigation offering. It can easily fit within a suitcase...
Mar 05 2020,
NGMedical’s First Implantations with MOVE-C Cervical Disc
MOVE-C combines the features of a second-generation disc prosthesis with the implantation technique of a cervical cage. The device offers...
Feb 21 2020,
FDA-Cleared Navigation, Planning and Robotic Systems
Enabling technology will be a large focus in 2020. In preparation for announcements to come, we took stock of FDA...
Feb 11 2020,
In2Bones Gains FDA Clearance for Quantum Total Ankle
The clearance marks the company’s entrance into the total ankle replacement market and complements its products for upper and lower...
Feb 07 2020,
RSIP Vision: Company to Watch in Surgical Planning
RSIP Vision has taken additional steps to apply its technologies to the planning of hip and shoulder replacement....
Feb 07 2020,
Year in Review: Orthopedic Companies with First U.S. Products
One of our favorite lists that we compile every year is newer companies that hit our radar. This review pinpoints...
Jan 21 2020,
FDA 510(k) Recap: 9 First Clearances and Line Extensions
This month’s recap highlights devices of interest that received first clearances from companies new on our radar, like Augmedics, Avanti...
Jan 21 2020,
Silver Bullet Therapeutics Gains CE Mark for OrthoFuzIon Bone Screw
An expanded CE Mark positions the company to improve patient care in the EU, and potentially disrupt the established commercial...
Jan 20 2020,
Augmedics Launches xvision AR Surgical Guidance
The augmented reality system allows surgeons to visualize anatomy in real time, as if using x-ray vision, to guide instruments...
Jan 06 2020,