Atlas Spine, Inc., recently received 510(k) clearance by the U.S. Food and Drug Administration for the Ortus Expandable Posterior Lumbar Interbody System.
Atlas Spine’s Ortus PL Receives FDA Clearance
1 min read Premium comments
Secondary
According to a press release, this device can be used in either a minimally invasive or open surgical approach and has one of the smallest starting heights (6.5mm) of any expandable device on the market. With the Ortus Expandable Posterior Lumbar Interbody System (Ortus PL), implant expansion to restore anatomic alignment can happen in one step. And because the device was designed with an open architecture, the surgeon can add graft material after the system is deployed and expanded.
“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,” said Atlas Spine’s co-founder and chief technology officer Matthew Baynham in the release.
“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 [minimally invasive surgery].”
Douglass Watson, chief executive officer of Atlas Spine in the release. “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.”
Atlas Spine is a high technology, spinal implant and instrumentation company based in Jupiter, Florida.
React:
Discussion
This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
Join the conversation
Orthopedic professionals are discussing this. Sign in and upgrade to read every comment and add your voice.