FDA grants 510k clearance of the CTL Amedica Navigation Instrument System

FOR IMMEDIATE RELEASE: DALLAS (MAY 18, 2022)... CTL Amedica Corporation has received official 510k clearance from the U.S. Food and Drug Administration (FDA) to market the CTL Amedica Navigation Instrument System, registration number K213491. The system features manual surgical instruments adaptable for use with third-party navigation systems, which are designed to assist surgeons in precisely locating anatomical structures in either open, minimally invasive or percutaneous procedures for preparation and placement of pedicle screws.

“The CTL Amedica Navigation Instrument System is intended to be used during the preparation and placement of CTL Amedica screws during spinal surgery. It is an innovative system of drivers, taps, awls, probes and drills that enables surgeons to navigate anatomic structures with insightful precision. This can make a tremendous difference for surgeons and their patients, ultimately reducing procedure times and improving outcomes,” said Daniel Chon, chief executive officer for CTL Amedica. “I’d like to thank everyone who provided support and feedback to help make this endeavor a reality.”

CTL Amedica Navigation Instruments are manufactured from stainless steel and aluminum and conform to ASTM F899 and ASTM B221. The system is compatible with CTL Amedica’s RAPHAEL™ Pedicle Screw System Family, the PICASSO II™ MIS Spinal System Family and the TAURUS™ Pedicle Screw System Family.

The third-party navigation systems are indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where reference to a rigid anatomical structure, such as vertebra, can be identified relative to a CT- or MR-based model, fluoroscopy images or digitized landmarks for the anatomy. The surgical imaging technology provides surgeons visualization for complex and MIS procedures and aids in establishing trajectory during advanced surgical procedures. These navigation systems provide surgeons with access to real-time, multi-plane 2D and 3D images, providing visual representation of hardware placement.

Chon adds that CTL Amedica has several other products awaiting FDA 510k approval, and the company looks forward to announcing them in the coming months.

CTL Amedica is a forward-thinking medical device design, development and manufacturing company. CTL Amedica maintains a Texas-based headquarters and in-house manufacturing facility, along with a Pennsylvania-based R&D Center of Excellence. A leader in the medical device technology and biomaterials space, CTL Amedica provides a full line of cervical, thoracic and lumbar fusion and fixation products. In addition, it is the world’s exclusive provider of silicon nitride spine products. Silicon nitride demonstrates an enhanced osteogenic response for enhanced fusion, promotes unique anti-bacterial properties and provides comprehensive imaging across all modalities. For more information, visit https://www.ctlamedica.com/.