SPINAL elements

OPTIMUS Instructions for use

6 Pages

OPTIMUS  CUSTOM SPINE OPTIMUS: STAND-ALONE ANTERIOR LUMBAR DEVICE CAUTION: Federal law (U.S.A.) restricts this device to sale by or on the order of a licensed physician. CONSISTS OF STERILE AND NON-STERILE PRODUCT NON-STERILE PRODUCT MUST BE STERILIZED PRIOR TO USE SINGLE USE ONLY  DEVICE DESCRIPTION OPTIMUS consists of fixation plates, end caps, and bone screws for stand-alone anterior intervertebral body fusion. OPTIMUS is available in a variety of heights (9-13mm posterior), angles (6, 10 and 14 degrees) and two footprints (25x32mm and 29x36mm) to accommodate variations in patient anatomy. The end caps, which attach to the fixation plate, come in either PEEK or titanium and are plasma sprayed with CP-titanium. The bone screws are Ø5mm and are available in three lengths (24, 28, and 32mm). MATERIALS OPTIMUS is fabricated from the following materials: • PEEK-OPTIMA™ LT1 (PEEK-OPTIMA™ is a trademark of Invibio, Ltd.) per ASTM specification F-2026 (end caps) • Titanium alloy (Ti6Al4V) per ASTM specification F-136 (fixation plate, end caps, and bone screws) • CP-Titanium per ASTM specification F-1580 (end caps plasma sprayed surface coating) INDICATIONS The OPTIMUS Anterior Lumbar Interbody Fusion (ALIF) System is indicated for intervertebral body fusion procedures at one or two contiguous levels (L2-Sl) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by the history and radiographic studies. DDD patients may also have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. The patient should be skeletally mature and have had six months of non-operative treatment. The OPTIMUS Anterior Lumbar Interbody Fusion (ALIF) System is a stand-alone system intended to be used with bone screws, autogenous bone graft and requires no additional supplementary fixations. One device is used per intervertebral space. CONTRAINDICATIONS • Any abnormality present which affects the normal process of bone remodeling including, but not limited to, severe osteoporosis involving the spine, active infection at the site or certain metabolic disorders affecting osteogenesis. • Insufficient quality or quantity of bone which would inhibit rigid device fixation. • Patients with infection, inflammation, fever, tumors, elevated white blood count, open wounds, pregnancy, and other medical conditions which would prohibit beneficial surgical outcome. • Any neuromuscular deficit which places an unusually heavy load on the device during the healing period. • Obesity. An overweight of obese patient can produce loads on the spinal system which can lead to failure of the fixation of the device or to failure of the device itself. • Patients having inadequate tissue coverage of the operative site. • A condition of senility, mental illness, or substance abuse. These conditions, among others, may cause the patient to ignore certain necessary limitations and precautions in the use of the implant, leading to failure or other complications.  CSI-LB-136 Rev. 20190703
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