Tag: pedicle screw
VisAR augmented reality guidance system achieves promising results in spine surgery...
The VisAR augmented reality surgical guidance system (Novarad) is a highly accurate, emerging technology for navigating both open and minimally invasive spine surgery (MISS)...
Waypoint Orthopedics submits FDA 510(k) application for Waypoint GPS system
Waypoint Orthopedics recently announced the submission of a US Food and Drug Administration (FDA) 510(k) application for its Waypoint GPS—a bone awl for use...
CoreLink announces commercial launch of CentraFix midline fixation system
CoreLink has announced the commercial launch and 510(k) clearance from the US Food and Drug Administration (FDA) for its CentraFix midline fixation system—which features...
SeaSpine announces limited commercial launch of Mariner MIS Wayfinder
SeaSpine has announced the limited commercial launch and completion of initial surgeries of the Mariner MIS Wayfinder—a novel, one-step, k-wireless screw delivery system for...
Biedermann Motech further expands MOSS VRS pedicle screw platform
Biedermann Motech has announced that its MOSS VRS pedicle screw platform is now available as a fully modular solution.
The MOSS VRS system features Next Generation...
Intelivation Technologies receives FDA approval for its Golden Isles Pedicle Screw...
Intelivation Technologies has announced that the company has achieved US Food and Drug Administration (FDA) 510(k) clearance of its Golden Isles Pedicle Screw System.
The Golden Isles...
Texas Back Institute performs first minimally invasive case with DeGen’s E3...
DeGen Medical has announced the first implant of the E3 MIS pedicle screw system at Texas Back Institute in Plano, USA. The minimally invasive...
HPS 2.0 Hybrid Performance System used for the first time during...
RTI Surgical has announced the first surgery using the HPS 2.0 Hybrid Performance System, a modular pedicle screw system used for mono- and multi-segmental rigid,...
Ennovate® PolyLock®: Solutions Beyond Fusion
The Ennovate® PentaCore® Screw is the new benchmark in the Pedicle Screw Systems market. Ennovate screws have a significantly higher pullout force, shear strength, and...
Augmented reality surgical navigation technology enables high accuracy pedicle screw placement
A recent study reports that new technology utilising augmented reality surgical navigation can be clinically used to place pedicle screws, enabling both high accuracy...
Stryker reaches 100 surgeon milestone for “game-changing” Serrato screws
Stryker’s Serrato pedicle screws have been implanted by more than 100 surgeons across the USA during the first 30 days of limited release.
A...
US FDA clears Stryker’s Serrato pedicle screw
Stryker’s Spine division has announced that its Serrato pedicle screw, intended for use in the non-cervical spine as part of the company’s Xia 3...
Full market release announced for Nexxt Spine’s Inertia Corti-fixx pedicle screw...
Nexxt Spine has announced the full market release of the company’s Inertia Corti-Fixx cortical-cancellous pedicle screw system.
Corti-Fixx screws are designed to achieve greater...
GS Medical USA announces new product portfolio
GS Medical USA has announced the confirmed and pending launch of several US Food and Drug Administration (FDA) 510(k)-approved products.
The company plans to launch...
US FDA clears SpineGuard’s DSG third-party pedicle screw integration module
SpineGuard has received 510(k) clearance from the US Food and Drug Administration (FDA) for its new DSG (Dynamic Surgical Guidance) integration module to be...
US FDA downgrades class III pedicle screws to class II
The US Food and Drug Administration (FDA) has formally reclassified pedicle screws from class III to class II devices. The reclassification came into force...
Safe Orthopaedics receives CE mark for thoracic version of its Oak...
Safe Orthopaedics has received CE mark for a new version of its patented Oak screw, used to treat thoracic vertebral fractures.
Previously, 7.5mm, 6.5mm and...
Signus receives US FDA 510(k) clearance for Diplomat posterior pedicle screw...
Signus has received 510(k) clearance from the US Food and Drug Administration (FDA) for the new Diplomat pedicle screw system.
The Diplomat has been developed...