Ventris Intervertebral Body Fusion Device

The Ventris IBFD is an intervertebral body fusion device system for lumbar spine fusion using anterior, anterolateral, or lateral surgical approaches. It is indicated for skeletally mature patients who have failed at least six months of non-operative treatment and have degenerative disc disease with up to Grade I spondylolisthesis. The device is used with allogeneic bone graft to facilitate fusion at one or two contiguous levels from L2 to S1.

The Ventris system uses titanium alloy cages and cover plates manufactured via laser powder bed fusion (L-PBF) additive manufacturing, with optional hydroxyapatite (HA) coating. Differences from predicates include a new device name, additional implant height and lordosis options, additional cage configurations with increased endplate surface area, expanded bone screw and cover plate options, updated instrument designs, and a change to a new additive manufacturing supplier.

ASTM F2077 Test Methods for Intervertebral Body Fusion Devices, ASTM F2267 Standard Test Method for Measuring Load Induced Subsidence, ASTM F3001 Standard Specification for Additive Manufacturing Titanium-6 Aluminum-4 Vanadium, and ASTM F1537 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium (ELI) surgical implant material specifications.

The Ventris system is substantially equivalent to predicate A-Link Z (K201671) because it has identical indications for use, design, dimensions, and materials. Mechanical testing and worst-case analysis on new implant sizes and configurations demonstrated performance equivalence to the predicates under ASTM standards. The change in additive manufacturing supplier and added features (implant heights, lordosis options, surface area configurations) do not raise new safety or effectiveness concerns, as validated by mechanical performance, biocompatibility, and sterilization testing.