FDA 510(k) Recap: 10 Products in Joint Replacement and Spine
This month, we look at companies that received their first orthopedic-related clearance such as FX Shoulder USA, Amplify Surgical and...
Nov 18 2019,
Products
DiFusion Gains FDA Clearance for Xiphos ZFUZE Biomaterial
The first of its kind biomaterial is offered as an alternative to PEEK and titanium materials for interbody devices....
Nov 14 2019,
Smith+Nephew Launches OR30 Dual Mobility Hip
OXINIUM Technology is the first advanced bearing material available to support modular dual mobility throughout the entire offering....
Nov 14 2019,
FDA 510(k) Success Dependent upon Pre-submission Planning
How should you prepare for FDA 510(k) submissions in 2020? Start with a thorough understanding of the testing and verification...
Nov 04 2019,
DePuy Synthes to Promote TINAVI Robotic Solutions in China
Together, the companies will jointly promote the rapid development of digital surgery and technological medical innovation, providing insights for the...
Oct 31 2019,
Stryker Gains FDA Clearance for SAHARA Lateral 3D Expandable Interbody
Stryker received FDA 510(k) clearance to market the SAHARA® Lateral 3D Expandable Interbody System featuring Lamellar 3D Titanium Technology. This...
Oct 31 2019,
THINK Surgical Gains FDA Clearance for Robotic Knee Replacement Application
Previously available in Asia Pacific and European markets, the TSolution One system is now cleared for use in the U.S....
Oct 21 2019,
3 Stem Cell Product Updates: Knee OA Clinical Trials, Degenerative Disc Treatment Launch
Clinical trials are underway in the U.S. and China for use of stem cell therapies in the treatment of knee...
Oct 21 2019,
Zimmer Biomet, CarboFix and Aegis Spine Make Post-NASS Announcements
Zimmer Biomet introduced its first porous titanium implants to be additively manufactured. Aegis added expandable cages to its portfolio, and...
Oct 21 2019,
Brainlab, Epica, Onkos Surgical Launch New Surgical Enabling Tools
Brainlab is back with more robotic technology, Epica’s mobile CT imaging is cleared for human use applications and Onkos enhances...
Oct 07 2019,
6 Companies Expand Robotic, Imaging, Navigation Tools via 2019 M&A
Acquisitions in the first nine months of the year afforded joint replacement and spine companies access to new enabling technologies...
Oct 01 2019,
FDA 510(k) Recap: 10 Shoulder Implants and Technologies
Nine shoulder replacement implants, including two stemless offerings, and one positioning guide received FDA 510(k) clearance thus far in 2019....
Oct 01 2019,
Sports Medicine Product Updates: CoNextions Medical and Fuse Medical
In keeping an eye on lesser-known companies, we noticed two up-and-comers to share. These small startups are increasingly appearing in...
Sep 24 2019,
Knee Replacement Launches: ATTUNE Cementless, Persona Revision and Sterizo Total Knee
Knee segment leaders DePuy Synthes (#3) and Zimmer Biomet (#1) enhanced their offerings and noted that their new knee systems...
Sep 24 2019,
Trauma: A Regulatory and Product Launch Recap
The number of companies in the trauma space may surprise you since the largest orthopedic players—DePuy Synthes, Stryker, Zimmer Biomet...
Sep 23 2019,