Jupiter, Florida., October 31, 2017 (PR NEWSWIRE) — Atlas Spine, Inc., a high technology, spinal implant and instrumentation company based in Jupiter, Florida, today announced that the Ortus™ Expandable Posterior Lumbar Interbody System has been 510(k) cleared by the U.S. Food and Drug Administration (FDA). The device is designed to be delivered using either minimally invasive or open surgical approach. The Ortus™ PL is clearly differentiated from other expandable technology. For example it has one of the smallest starting heights (6.5mm) of any expandable device on the market, and relies on a unique, patented design that allows for implant expansion while restoring natural anatomic alignment in a single step. The device also features an open architecture that allows the surgeon to pack ample graft material after the device is deployed and expanded. This is the first implant in a comprehensive line of expandable interbody intellectual property that utilizes anterior, PLIF, oblique, and minimally invasive approaches and devices that the company plans on launching.
“Atlas has a deep pipeline of expandable technology and the Ortus™ 510(k) clearance presents a tremendous opportunity to establish our company as an expandable interbody technology market leader. The Ortus™ platform provides options and capabilities for surgeons focused on restoring spinal balance that is yet to be provided by other devices and companies. Paired with a minimally invasive surgical approach, Ortus™ PL is a powerful tool for spine surgeons seeking reliable fusions with minimal complexity and post-operative morbidity. Furthermore, the Ortus™ PL platform is well suited for anterior, posterior, lateral and oblique approaches, in addition to MIS,” notes Atlas Spine’s co-founder and CTO Matthew Baynham.
Atlas Spine’s CEO Douglass Watson adds, “We are thrilled to be in the expandable posterior lumbar interbody market. The response from key, opinion-leading surgeons is tremendous. We are preparing to launch the Ortus™ PL interbody device with our distributor network in the near future and look forward to numerous additional differentiated device clearances over the next several quarters.”
The U.S. FDA notified the company on the first day of the North Atlantic Spine Society (NASS) meeting. This is Atlas Spine, Inc’s 12th product to receive 510(k) clearance by the U.S. FDA and allows the Company to access distribution channels and gain measurable market share. It also allows the company to focus on commercializing other significant projects in the pipeline.
About Atlas Spine, Inc.
Our mission is to create spinal implants and instrument systems that treat a variety of pathologies combining the highest level of performance with ease of use which translate to physician satisfaction and enhanced patient outcomes. The company has over 50 issued and pending patents and currently distributes a number of interbody and posterior stabilization systems and has also licensed technology to other companies in the spinal device market.
For more information about Atlas Spine, please visit atlasspine.com.
Contact: Matthew Miller, Atlas Spine Inc., (561) 741-1108 or mmiller@atlasspine.com. Atlas Spine Inc., 1555 Jupiter Park Drive, Suite 1; Jupiter, Florida 33458.