Idys® LIF

The Idys® LIF is a lumbar interbody fusion cage made of PEEK with tantalum or titanium markers, designed to restore intervertebral height and lordosis while containing autologous bone graft. It is indicated for use in patients with degenerative disc disease at one or two spinal levels (L2–S1 depending on approach type) who have failed six months of conservative treatment and may have up to Grade 1 spondylolisthesis or retrolisthesis.

The device possesses the same technological characteristics as the predicate (Idys® LIF Cages, K131178), with two minor differences: it is supplied in a non-sterile state requiring sterilization prior to use, and it includes dedicated trays for transportation, storage, and sterilization equivalent to state-of-the-art orthopedic device standards. The fundamental materials (PEEK, tantalum, titanium alloy) and design principles remain unchanged.

ASTM F2077 (static and dynamic axial compression testing) and ASTM F2267 (static and dynamic compression shear testing); additional testing included subsidence, expulsion, torsion, and wear testing.

The device has identical intended use and principles of operation as the predicate, with the same indications for use except removal of L2–L3 levels for PTLIF only. The non-sterile state and dedicated trays are minor technological differences that raise no new safety or effectiveness concerns. Performance testing demonstrates equivalence to the predicate across all mechanical parameters, establishing substantial equivalence without any material change in device function or clinical performance.