First 510(k) Clearance Recap and Surgical Enabling Technologies of Note
This recap covers two companies that achieved first U.S. clearances in recent months, and two by established companies in the...
Sep 20 2021,
Products
FDA De Novo Classification Granted for Zimmer Biomet Persona IQ Knee
The Persona IQ Knee combines Zimmer Biomet's Persona Knee with Canary Medical's canturio te tibial extension sensor technology....
Sep 01 2021,
Smith+Nephew Debuts RI.HIP NAVIGATION Software
The company will expand the Real Intelligence digital ecosystem and CORI Surgical System with total hip arthroplasty....
Sep 01 2021,
MiRus Gains FDA 510(k) for IO Expandable Lumbar Interbody
The IO Expandable Lumbar Interbody, powered by the MoRe Expansion Engine, offers the lowest profile interbody on the market....
Sep 01 2021,
DJO Introduces New EMPOWR Dual Mobility Hip
The EMPOWR Dual Mobility offers the industry’s largest assembled head size for a given cup size, aiding in enhanced joint...
Sep 01 2021,
Conformis Announces First Case with the Identity Imprint Knee
Identity Imprint utilizes a proprietary algorithm to select the implant size that most closely meets the geometric and anatomic requirements...
Aug 25 2021,
Shoulder Innovations Receives FDA Clearance For InSet Reverse Shoulder
The latest clearance rounds out the company's product line for shoulder replacement....
Aug 25 2021,
Globus Medical Receives FDA 510(k) Clearance for Excelsius3D
Globus Medical received FDA 510(k) clearance for Excelsius3D, an intelligent intraoperative 3-in-1 imaging system....
Aug 25 2021,
Technology Notebook: Product Launches
Learn of the latest products from new and established companies....
Aug 19 2021,
FDA Recap: Clearances Across Orthopedic Market Segments
We share a variety of established, but lesser-known companies that achieved FDA 510(k) clearances within 2021....
Aug 19 2021,
FDA 510(k) Recap: First Clearances from Around the World
This month’s recap spans the globe and all five market segments, with companies based in Canada, India, Switzerland, the United...
Jun 28 2021,
Silver-Coated Bone Screw System Receives CE Mark for Expanded Indications
Silver Bullet Therapeutics bone screws are designed to kill bacteria in 24 hours after surgery. The company’s new CE Mark...
Mar 23 2021,
Additive Manufactured Talus Spacer Receives Humanitarian Use Designation from FDA
Additive Orthopaedics’ Patient Specific Talus Spacer is meant to alleviate the impact of avascular necrosis....
Mar 22 2021,
FDA 510(k) Recap: First Clearances for Companies in 1Q21
New year, new entrants to the U.S. orthopedic market. This installation of the 510(k) recap offers up companies based in...
Feb 22 2021,
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,