Infinity™ OCT System

The Infinity™ OCT System is a posterior occipitocervical-upper thoracic spinal fixation system consisting of plates, rods, hooks, screws, and connecting components made from medical-grade titanium alloy and cobalt chromium. It is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for acute and chronic instabilities including traumatic fractures, instability, failed fusions, tumors, and degenerative disease of the cervical spine (C1-C7) and upper thoracic spine (T1-T3), used with autograft and/or allograft.

The subject device has the same intended use, indications for use, materials (titanium alloy and cobalt chromium), similar overall design, fundamental technology, sterilization method, and surgical technique as the predicate Infinity™ OCT System (K163375) and related spinal systems including CD HORIZON® Spinal System, VERTEX® Reconstruction System, and Stealth™ Spine Clamps. The subject and predicate implants and instruments share the same function and fundamental scientific technology.

ASTM F2193 for static four-point bend and four-point bend fatigue testing.

Medtronic demonstrates substantial equivalence by showing the subject devices have identical intended use, indications, materials, design, and fundamental technology as multiple predicate devices. Testing per ASTM F2193 met pre-determined acceptance criteria, and rationalized devices rely on existing predicate data. Design validation confirmed the devices perform as intended, establishing substantial equivalence to the predicate devices.