Spineology has received approval from the US Food and Drug Administration (FDA) to use allograft bone with its Rampart Interbody Fusion Devices.
Rampart interbody fusion devices integrate large graft windows to facilitate healing and a recently improved instrumentation system.
The devices are available with sterile packaging, helping to avoid continual reprocessing.
Incite cortical fibers are bone grafting solutions, which feature an osteoconductive and inductive matrix, as well as enhanced handling properties.
The fibers also offer in-situ expansion and placement options through a variety of delivery methods.
Spineology CEO John Booth said: “This approval and our recent partnership expansion with Musculoskeletal Transplant Foundation (MTF) provides us the ability to pair MTF allografts with the Rampart family of interbody devices.
“In addition to reducing patient morbidity and enhancing surgical efficiency we expect this approval will provide Spineology with an excellent platform for delivery of our new Incite Cortical Fibers.”
Spineology provides anatomy conserving spinal technologies for surgeons and their patients.
The company produces interbody, fixation, and access systems to conserve spinal bone, ligament and muscle tissue.
Spineology produces Threshold and Fortress pedicular fixation systems and CapLOX II spinal system. It also produces non pedicular Capture Facet and VIA spinous fixation systems.
In addition, the company produces biologic products such as Prime liquid tisuue matrix, Armor amniotic wound covering and Incite allografts.