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,
Products
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,
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,
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,