The Karma® Fixation System

The Karma Fixation System is a PEEK-based facet fixation device designed to provide adjunctive stabilization during single-level lumbar interbody fusion (L1-L5) in skeletally mature patients with degenerative disc disease who have failed conservative care. The device consists of a PEEK band with a spherical tip, tapered neck, integrated teeth, and a latching mechanism that tightens around bilateral facet joints to secure bony structures.

The Karma Fixation System is identical to the reference device in design, components, materials, chemical composition, manufacturing, labeling, and sterility. It consists of a PEEK strap compounded with 7.5% barium sulfate for radiopacity, includes a tantalum insert in the spherical tip for fluoroscopic visualization, and employs a ratcheting latch mechanism to create and maintain tension around spinal structures.

Not stated in this summary.

The device demonstrates substantial equivalence because it is identical in design and technological characteristics to the previously cleared reference devices (Karma Fixation System K180728/K190289 and zLOCK K240085), has the same intended indications for use, and provides equivalent performance as evidenced by identical biomechanical properties, comparable usability, and clinical data showing appropriate safety and efficacy in intra-laminar placement at 12-24 months follow-up.