DeGen Medical Gains New FDA Clearances

By Julie A. Vetalice

DeGen Medical received FDA clearance to market the F1 MP's Modular Pedicle Screw System for JOUST™ Minimally Invasive Surgery and the Cyclops' Anterior Cervical Plate.

JOUST employs MIS Towers for percutaneous screw placement in the traditional or cortical approach, with built-in rod reduction. JOUST enables screw placement with minimal muscle stripping, leading to the formation of less scar tissue.

The JOUST™ MIS technology with F1 MP's System will be available in Q4 of 2019.

Cyclops is a short, low profile plate available in multiple lengths, with hyper-angulated screws to support fixed, variable or hybrid constructs.

Both JOUST and Cyclops will launch in 4Q19.

DeGen Medical Cyclops Anterior Cervical Plate
Cyclops Anterior Cervical Plate

Source: DeGen Medical Cyclops; DeGen Medical F1 MPS

Tags: 510(k) Clearance, Regulatory