DePuy Synthes Gains FDA Clearance for VELYS Robot with ATTUNE Knee
The VELYS Robotic-Assisted Solution adapts to the surgical workflow, and helps surgeons execute accurate bony cuts....
Jan 26 2021,
Competitive Landscape
EU Allows Notified Bodies to Conduct Audits Remotely
While remote auditing will be conducted on a case-by-case basis, Notified Bodies and members of industry expect the shift could...
Jan 26 2021,
FDA 510(k) Recap: First Orthopedic Clearances
This month’s recap informs you of companies entering the major orthopedic market segments with their first product clearance. The six...
Jan 25 2021,
FDA Releases AI Action Plan for Medical Devices
FDA’s five-point plan outlines the Agency’s thoughts on a tailored regulatory framework, good machine learning practices, patient approaches, technology biases and...
Jan 25 2021,
Additive, AI, Digital Health Noted in FDA’s 2021 Science Report
FDA published its Focus Areas of Regulatory Science report, prioritizing research across the strategic initiatives of data, increasing choice and...
Jan 12 2021,
FDA Adds Bone Screws and Spine Plates to Alternative 510(k) Pathway
The voluntary Safety and Performance Based Pathway allows manufacturers with moderate-risk devices to meet specific performance criteria instead of testing...
Jan 11 2021,
FDA 510(k) Recap: 2020 Highlights Across the Market Segments
Close to 550 orthopedic products received clearances in this hectic year, allowing us to keep this popular monthly 510(k) recap...
Dec 15 2020,
Surgeons Share Lessons from 2020, Technology Predictions
While 2020 brought unpredictability, it highlighted numerous opportunities for improvement of processes and technologies with digital tools, additive manufacturing and...
Nov 24 2020,
Clinical Trials Shift to Hybrid Approaches in the Age of COVID-19 and Beyond
Conducting successful clinical trials will require orthopedic companies to demonstrate flexibility and adaptability in the future. ...
Nov 24 2020,
First 510(k)s for Companies in Joint Replacement, Spine, Trauma, SportsMed and Obio
This month’s recap rounds up many companies new on our radar, helmed by people who've known the industry for a...
Nov 17 2020,
Trauma Technologies Emerge to Meet the Needs of Patient Anatomy
A burgeoning set of small orthopedic implant companies is developing devices designed to anticipate and suit individual patients’ unique anatomy....
Nov 16 2020,
3 DF(x) Elements to Follow for New Product Development
A modern design for manufacturability approach forces orthopedic device companies to develop products aligned with customer needs and business needs....
Nov 16 2020,
How to Take a Risk-Based Approach to Biocompatibility
The ISO 10993-1 changes have re-emphasized the need for orthopedic companies to understand and characterize the materials, processes and risks...
Nov 16 2020,
Cerapedics’ Deliberate, Thorough Approach was Crucial for i-FACTOR’s Success
Cerapedics is one of only two companies with FDA Class III bone graft technology approved for the spine market. The...
Nov 02 2020,
MDR Experts Share How to Successfully Navigate the Requirements
Notified Body representatives and regulatory consultants provided an update on MDR compliance at OSMA's summer meeting. We review the advice...
Oct 30 2020,