FDA 510(k) Recap: First Clearances in 2020
We profile five companies that received their first FDA 510(k) clearances in 2020. Three of these companies are headquartered outside...
Sep 22 2020,
Cloud Conscious: How Data Can Optimize Orthopedic Supply Chains
4 Human Factors Practices that Lead to Successful FDA Submission
Nearly 90% of FDA 510(k) submissions receive reviewer comments related to human factors engineering. While these four practices are likely not...
Sep 22 2020,
Think Deep: Tools to be Less Distracted in Your Work
Ridding yourself of distraction to meaningfully focus on your work takes discipline and time. The result, though, enables more profound,...
Sep 22 2020,
Researchers Developing a Plastic Biomaterial for Use in Orthopedics
“This is a new class of biocompatible plastic that is as strong as nylons but is much easier to shape...
Sep 22 2020,
10 Spine Companies Receive Their First FDA 510(k)
Thus far in 2020, ten companies received their FDA 510(k) clearances that were not only firsts for the company, but...
Sep 18 2020,
How COVID Has Impacted the Delivery of Spine Care
Dr. Eeric Truumees shares COVID-19's impact on his practice and current and future trends in spine care....
Sep 18 2020,
DWFritz Introduces ZeroTouch Portfolio of Metrology and Inspection Platforms
The high-speed, non-contact metrology and inspection platforms are designed to decrease total cost while improving overall product quality and production...
Sep 09 2020,
MCRA Appoints Director for Medical Device Digital Health and Cybersecurity Franchise
MCRA's digital health and cybersecurity services are focused on the entire technology lifecycle continuum, from FDA submissions to pre- and...
Sep 08 2020,
DFM: A Vital Supply Chain Perspective
Using a thorough supplier risk assessment during DFM is critical in creating a robust supply chain that can prevail in...
Sep 08 2020,
How OIC’s Value-Based Implant Platform is Meeting the Moment During the Pandemic
Long before the pandemic began upending almost everything about orthopedics and life in general, the President and Chief Executive Officer...
Sep 03 2020,
New Alloy Emerges in Response to Patient Sensitivities and Regulatory Changes
BioDur®, an essentially nickel- and cobalt-free stainless-steel alloy, has been identified for use in implantable medical devices and surgical instruments....
Sep 03 2020,
Video: Lincotek CEO Shares Preparations for COVID Recovery
Lincotek was integrating its acquisition of CoorsTek Medical and preparing for multiple facility expansions when COVID hit. Company CEO Winfried...
Sep 03 2020,
Lincotek Medical Increases Implant Coating Capacity, Strengthens Global Risk Mitigation Capabilities
The company added two more air plasma spray lines at its Trento, Italy facility....
Sep 01 2020,
AV&R Launches Robotic Systems for Implant Production
The company has developed robotic systems that now perform various surface finishing processes on implants such as knees and hips....
Aug 28 2020,
FDA Clears First 3D Printed HAnano Surface Modified Implant
Promimic AB announced Innovasis received the first FDA 510(k) clearance of a 3D printed porous titanium implant modified with the...
Aug 25 2020,