MSFX MIKRON PEEK CAGES

The MSFX Mikron PEEK Cages are intervertebral body fusion devices for spinal surgery. The cervical version is implanted to provide stability for fusion after diseased disc removal in patients with degenerative disc disease at one level (C2-T1). The lumbar version is used for fusion at one or two contiguous levels (L2-S1) in patients with degenerative disc disease and up to Grade 1 spondylolisthesis. Both versions use PEEK cage bodies with titanium components and are used with supplemental fixation and autograft bone.

The MSFX Mikron Peek Cages have the same technological characteristics as the predicate devices. The cervical cage body is made from PEEK (ASTM F2026) with pins, markers and screws from Ti6Al4V ELI (ASTM F136). The lumbar cage body is also PEEK with pins, markers and expansion mechanisms from Ti6Al4V ELI. Both are placed via anterior approach with supplemental fixation.

ASTM F2077 (Static Axial Compression Test, Static Axial Compression Shear Test, Static Torsion Test, Dynamic Axial Compression Test, Dynamic Axial Compression Shear Test, and Dynamic Torsion Test) and ASTM F2267 (Subsidence).

MSFX Mikron Peek Cages are substantially equivalent to the predicate devices because they have identical indications for use and the same technological characteristics. Biomechanical testing per ASTM F2077 and F2267 demonstrates equivalent performance to legally marketed predicates, confirming the device is as safe, effective, and performs as well as the predicate devices.