FDA 510(k) Recap: Companies Gain Trauma Device Clearances
As the Orthopedic Trauma Association holds its Annual Meeting this week, we look at companies that seek to make a...
Oct 20 2020,
Competitive Landscape
Innovative Technologies Shake Up the Orthopedic Space
Dozens of startups are poised to shake up the orthopedic space in the near-term and beyond. We start by examining...
Sep 30 2020,
Considerations for Your Device’s Manual and Mechanical Cleaning Validations
Proper cleaning protocols for reusable medical devices have become a major focus in light of the recent superbug outbreaks associated...
Sep 30 2020,
The Future of Instruments is Disposable, Durable and Smarter
We spoke with instrument suppliers to find out what is top of mind for their customers and learn how they’re...
Sep 30 2020,
3D Printing and Robotics Lead China’s Technology Opportunities
OEMs and consultants said the primary market opportunities in China will be tied to advanced technology, including systems that aid...
Sep 22 2020,
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,
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,
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,
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,
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,
Acquisition Combines NN, Inc. and MW Industries’ Orthopedic Portfolios
MW Industries' parent company is acquiring NN Life Sciences for $825 million, and is combining the two entities into MW...
Aug 24 2020,
FDA 510(k) Recap: Total Ankle Clearances in 2020
The total ankle market is attractive for current and new players. We review four total ankle devices, three from new...
Aug 24 2020,
SI Joint Fusion Market Has Rapid Growth Potential
Minimally invasive SI joint fusion is an increasingly common treatment for patients with low back pain and represents a high-growth...
Aug 05 2020,
OEMs Look to Suppliers for Vendor Managed Inventory Help
Orthopedic suppliers have bolstered their vendor managed inventory services, providing OEMs product flexibility and transparency....
Aug 05 2020,