GoLIF! Lumbar Interbody Fusion System

The GoLIF! Lumbar Interbody Fusion System is engineered to facilitate interbody fusion in patients with symptomatic Degenerative Disc Disease and mild spondylolisthesis by restoring spinal column biomechanical integrity. Its design features, including a tapered tip, surface teeth, and dome shape, contribute to stable implantation, with regulatory clearance achieved through performance testing demonstrating substantial equivalence to existing medical devices.

GetSet Surgical, SA has received clearance to market its GoLIF! Lumbar Interbody Fusion System, which has been determined to be substantially equivalent to existing medical devices. This system is intended for interbody fusion using autograft and/or allogeneic bone graft in skeletally mature patients with symptomatic Degenerative Disc Disease (DDD) at one or two contiguous levels in the lumbar spine (L1-L2 to L5-S1). This includes patients with up to Grade 1 Spondylolisthesis or retrolisthesis, provided they have undergone six months of non-operative treatment. The system is designed to be used with supplemental posterior fixation.The GoLIF! Lumbar Interbody Fusion System comprises sterile implantable cages and accompanying surgical instruments. The implants are designed to restore the biomechanical integrity of the spinal column and can be inserted via open, minimally invasive posterior, or transforaminal approaches. Key features include a tapered tip for insertion, teeth on the surfaces to resist expulsion and migration, a dome shape for lordosis, and openings for bone graft. Performance testing, including mechanical tests (axial compression, compression shear, subsidence, and expulsion) and biocompatibility assessments, confirmed the device's safety and effectiveness by demonstrating its substantial equivalence to a legally marketed predicate device.

AI Regulatory Concerns

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Jev reads the full FDA letter and returns calibrated concern probabilities per regulatory category. These are AI estimates, not regulatory advice.

• Q1. What are the long-term clinical outcomes and fusion rates observed with the GoLIF! system compared to the predicate device or other established fusion techniques?; How do the specific design features (tapered tip, teeth, dome shape) of the GoLIF! cages functionally contribute to improved patient outcomes or reduced complications in vivo?; Are there specific patient populations (e.g., severe spondylolisthesis, multi-level DDD) for whom the GoLIF! system is less effective or potentially contraindicated, beyond the stated Grade 1?; What are the typical post-operative rehabilitation protocols recommended for patients receiving the GoLIF! system, and how do they impact recovery and fusion success?; Has any in-human data or post-market surveillance been collected to validate the mechanical test results and biocompatibility assessments in a clinical setting?