Benvenue Medical, Luna 3D and Orbit are registered trademarks of Benvenue Medical Inc.
LUNA 3D Interbody Fusion System:
Luna 3D Interbody System is available for sale in the United States.
The Luna 3D Interbody Fusion System consists of the Luna 3D Implant and associated accessories. This system is indicated for spinal fusion procedures in skeletally mature patients with symptomatic degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to grade I spondylolisthesis or retrolisthesis at the involved level(s). The Luna 3D Interbody Fusion System is to be used with autogenous bone graft. Patients receiving the device should have had at least six months of nonoperative treatment prior to receiving the Luna 3D Implant. The Luna 3D Interbody Fusion System is to be used with supplemental fixation.
As with other lumbar fusion devices and procedures, there are risks and considerations for use of the Luna 3D Interbody Fusion System. Please see the product labeling for a detailed discussion of risks, contraindications, warnings and precautions. Failure to follow any instructions or failure to heed any warnings or cautions could result in serious patient injury.
Orbit Discectomy System
The Orbit Instrument System (LUN6210) is made up of reusable instruments that are intended to facilitate a complete discectomy in preparation for the Luna 3D Implant. The instruments are comprised of stainless steel and polymeric materials. The perforated instrument tray is comprised of aluminum and has various silicone and aluminum brackets to hold the instruments in place during handling and storage.