Astura Medical Receives FDA 510(k) Clearance For  Olympic Deformity’s Sublaminar Bands Supplemental System

Astura Medical Receives FDA 510(k) Clearance For Olympic Deformity’s Sublaminar Bands Supplemental System

Authored: May 4, 2023

IRVING, TX – Astura Medical, a rapidly growing and innovative spine technology company, is proud to announce that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its revolutionary Sublaminar Bands, which will serve as a supplementary set to the Olympic Deformity Posterior Spinal Deformity System.

Building upon the technological advancements achieved with the Olympic Deformity System, Astura’s Sublaminar Bands Set provides surgeons with an alternative way to stabilize and correct spinal deformities by fastening rods and connectors.

“I’m proud of the efforts by our surgeon design partners and internal team to establish a new high-water mark for what’s possible in terms of intraoperative flexibility and versatility when sublaminar bands are utilized,” said Thomas Purcell, Co-founder, and Vice President.

The Sublaminar Bands System allows surgeons to choose between using a complete band-only technique or used in conjunction with the Olympic Deformity System to create a hybrid construct that allows for the use of Hooks, Pedicle Screws, and multiple connectors throughout the lumbar and thoracic spine, providing greater surgical precision and control. With an array of sublaminar PET bands and associated connectors, the system is designed to support the vertebral segments and ensure successful surgical outcomes that are tailored to each individual patient.

One of the features of the Sublaminar Bands System is its band tensioner, which is equipped with an integrated gauge feature. This feature enables surgeons to precisely measure the tension applied to the bands, ranging from 75 to 150N of force. This level of control and accuracy provides surgeons with greater confidence in their surgical procedures, ultimately leading to the aim of delivering more precise and successful surgeries.

The Sublaminar Bands System is the first of several supplemental systems to be added to the Olympic Deformity System this year, including Osteotomy and Direct Vertebral Rotation (DVR). The company is scheduled to introduce several new, expandable technologies in the coming months as well.

About Astura Medical

Astura Medical was formed in 2014 with the objective of creating a disciplined, multi-phased approach to developing, manufacturing, and distributing medical devices. With surgeon input and feedback at every stage of development, Astura has created an extensive line of devices of the highest quality and sleekest design.

The two essential pillars that contribute to Astura Medical’s success are high-quality products and robust distribution channels. These pillars, combined with passion and innovation, are what drive the Astura team to achieve great success with developing devices and entering them into the marketplace.