OneLIF™ Interbody Fusion System

The OneLIF™ Interbody Fusion System is an interbody fusion device for skeletally mature patients with degenerative disc disease, spinal deformity, spondylolisthesis, or failed previous fusion at the lumbosacral spine (L2-S1). The system consists of interbody cages and retention plates inserted via anterior or oblique approaches, optionally with accompanying screws, and is designed to be used with autograft or allogeneic bone graft.

The subject device has identical technological characteristics to its predicates: same indications for use, material of manufacture, structural support mechanism, implant sizes, and mechanical performance. The submission adds additional implant sizes to a previously cleared system, with minor design modifications that do not introduce new safety or effectiveness issues.

ASTM F2077 (dynamic testing of interbody fusion devices). The device was previously tested under this standard under K211769, and modified designs were retested per ASTM F2077 with engineering analysis to confirm no new worst-case scenarios.

Substantial equivalence is established because the subject device shares identical indications, materials, structural support mechanisms, implant sizes, and mechanical performance with its predicates (K211769 and K222561). Prior testing already demonstrated mechanical performance compliance under ASTM F2077, and additional dynamic testing and engineering analysis of the modified designs confirmed no new worst-cases or safety issues, supporting the conclusion that minor size additions maintain substantial equivalence.