PERLA® TL Posterior Thoraco-lumbar Fixation System

The PERLA® TL Posterior Thoraco-lumbar Fixation System is a spinal fixation device designed to immobilize and stabilize spinal segments in skeletally mature patients as an adjunct to fusion, treating conditions such as degenerative disc disease, spondylolisthesis, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion. It can also be used in pediatric patients for idiopathic scoliosis and in conjunction with TEKTONA® HV US bone cement for vertebral body restoration in advanced spinal tumors.

The PERLA® TL System consists of screws, rods, set screws, hooks, rod connectors, and cross-connectors manufactured from medical-grade titanium alloy and cobalt chromium conforming to ASTM F136 and ASTM F1537 standards. The added components are substantially equivalent to predicate devices in materials, overall design, range of sizes, mechanical performance, and sterilization methods.

ASTM F1717 (static compression, static torsion, and dynamic compression), ASTM F1798 (static axial gripping and static axial torsion gripping), and ASTM F2503 (MRI compatibility evaluation).

The subject device has the same intended use and indications as multiple PERLA® TL predicate devices (K193396, K203222, K213470, K231069). Design verification testing demonstrated substantial equivalence, with all pre-determined acceptance criteria met; for rationalized devices, existing predicate data remains applicable. Spineart concluded no new worst-case scenario exists and no clinical testing was required.