FDA clears Intelligent Implant Systems’ 2-level fusion Revolution system: 5 points

The FDA cleared Charlotte, N.C.-based Intelligent Implant Systems’ Revolution Spinal System’s two-level components.

Advertisement

Here are five points:

 

1. Surgeons can now use the Revolution Spinal System for two-level posterior thoraco-lumbar fusions.

 

2. Implanted with a single tray of all-sterile instruments, the system requires no contoured rods or screw placements. It offers controllable compression and distraction.

 

3. The system is intended to accelerate OR turn time as it simplifies procedures.

 

4. The two-level system uses the existing Revolution Connectors and a few additional components.

 

5. One-level sales began in October 2015, and many hospitals and ambulatory surgery center surgeons have used the system.

 

“With the addition of the two-level components the potential usage of the implant system now applies to the majority of patients, as most fusion are one and two-level,” said Marc Richelsoph, CEO, Intelligent Implant Systems.

 

More articles on devices:
Wenzel Spine’s VariLift-LX on full US commercial launch: 5 key notes
4th patient in INSPIRE study experiences AIS grade improvement: 5 things to know
Dr. Richard Ostrup uses Zeiss microscope for neurosurgery procedures: 5 highlights

At the Becker's 23rd Annual Spine, Orthopedic and Pain Management-Driven ASC + The Future of Spine Conference, taking place June 11-13 in Chicago, spine surgeons, orthopedic leaders and ASC executives will come together to explore minimally invasive techniques, ASC growth strategies and innovations shaping the future of outpatient spine care. Apply for complimentary registration now.

Advertisement

Next Up in Spinal Tech

  • From new technology acquisitions to regulatory clearances to leadership changes, here are 20 developments and updates from the biggest players…

  • SurGenTec’s ION-C earned FDA 510(k) clearance for ION-C navigation instruments with the ION-C posterior cervical facet fixation implant, according to…

  • VB Spine has made big pushes into the spine medtech space so far in 2026, including global expansions. Six headlines…

Advertisement

Comments are closed.