FDA 510(k) Recap: First Clearances in Spine, Trauma and Robotics
This month’s recap shares the companies that received their first 510(k) clearances within 2022, which included applications for spine, trauma...
Feb 23 2022,
Products
Medline Launching REFLEX Nitinol Dynamic Disc for Foot/Ankle
The REFLEX Nitinol Dynamic Disc helps to dynamize an otherwise traditional lag screw by harnessing superelastic and shape memory properties....
Feb 08 2022,
Innovasis Launches 3D-Printed Stand-Alone Titanium ALIF with HAnano Surface
Innovasis is the first company to receive FDA 510(k) clearance for a Stand-Alone ALIF System featuring HAnano Surface....
Feb 08 2022,
FDA 510(k) Recap: Companies with First Clearances in 2021
Here are the last of the companies from around the globe with first clearances in 2021 for products with spinal,...
Jan 25 2022,
First Patient Case with Stryker’s Tornier Perform Reversed Glenoid
Stryker's Tornier Perform Patient-Matched Glenoid is reportedly the first surgeon-driven, primary patient-specific implant available in shoulder arthroplasty....
Jan 25 2022,
Amber Implants Targets New Treatment for Vertebral Fractures
The company's additively manufactured spinal implant is designed to offer an alternative treatment for vertebral fractures, a complex injury usually...
Jan 21 2022,
FDA 510(k) Recap: Clearances Across Market Segments
Clearances include a reverse shoulder replacement, spinal interbody, distal radius plate and an artificial intelligence-based tool to diagnose knee osteoarthritis....
Dec 06 2021,
OsteoCentric’s Portfolio is Hyper-Focused on the Bone/Implant Interface
OsteoCentric is an orthopedic company working to create the Gold Standard for bone implant interfacing with its thread geometry technology....
Nov 09 2021,
FDA 510(k) Clearances for Robotic/Digital Tools in 2021
Learn about five companies that gained FDA 510(k) clearance this year for products in this robotic/digital segment serving orthopedics....
Nov 01 2021,
Bioretec Develops Absorbable Metal Implants for Orthopedic Trauma Applications
RemeOs is a resorbable screw only of metals naturally found in the human body and essential for new bone...
Oct 27 2021,
RevBio Looked Below the Ocean for a Novel Way to Treat Bone Fractures
RevBio developed Tetranite, a bone adhesive technology for novel fracture repair that can be applied to a wide range of...
Oct 25 2021,
Medtronic Expands Minimally Invasive Spine Ecosystem
The portfolio includes spinal implants, biologics, navigation, robotics and AI-powered data for surgeons and patients....
Oct 04 2021,
Kleiner Device Labs Debuts KG2 Surge Flow-Thru Interbody
KG2 Surge maximizes total bone graft delivery volume and better distributes graft bilaterally into the intervertebral disc space. ...
Oct 04 2021,
Intelivation Technologies Launches Advantage-C PEEK Cervical Interbody
Advantage-C was developed to optimize fusion, while maintaining elasticity that is similar to bone and radiolucency of the cage body. ...
Oct 04 2021,
6 Spine Companies Receive Breakthrough Device Designations from FDA
Spine companies are at the forefront of novel technologies in orthopedics, with more than a handful receiving FDA’s Breakthrough Device...
Sep 20 2021,