Tesera-k PL System and Tesera-k XL System

The Tesera-k PL and XL Systems are lumbar interbody fusion implants made from titanium alloy, designed to provide stability and facilitate spinal fusion in skeletally mature patients with degenerative disc disease at one or two levels from L2 to S1. Both systems are non-standalone and must be used with FDA-cleared supplemental fixation and bone graft.

The subject and predicate devices share identical indications for use, structure and function, materials of manufacture (titanium alloy), sterility requirements, and available sizes. The Tesera-k PL accommodates straight or curved profiles for posterior/transforaminal approaches, while the Tesera-k XL offers a straight profile for direct lateral approach. Minor differences in surgical approach do not raise new safety or effectiveness issues.

ASTM F2077 (static and dynamic axial compression, compression shear), ASTM F2267 (subsidence), ASTM F1147 (tensile strength), ASTM F1160 (shear fatigue), ASTM F1978 (abrasion), plus expulsion and subsidence testing.

The devices demonstrate substantially equivalent mechanical strength and performance to the five predicate devices (TiGer Shark, Aleutian IBF, NuVasive Modulus, Renovis S180, and Tesera-k ALIF) through identical non-clinical testing results. The technological characteristics—materials, sterility, indications, and structural design—are either identical or have only minor differences that do not create new safety or effectiveness concerns. The mechanical testing confirms the devices are suitable for their intended use in the same manner as legally marketed predicates.