SPINAL elements


9 Pages

Spinal Elements, Inc. · 3115 Melrose Dr., Suite 200 Carlsbad, CA 92010 · U.S.A. · 760.607.0121  OMEGA LUMBAR INTERBODY FUSION DEVICE PACKAGE INSERT (OMEGALIF®/OMEGA XP®) This package insert covers the OmegaLIF System and Manual Surgical Instruments that are used for the implantation of this system. Specific sections for implants and instrumentation highlight important user information for only those devices. GENERAL INFORMATION The OmegaLIF System devices are used to maintain disc space distraction in skeletally mature adults requiring intervertebral body fusion in the lumbar spine. They are designed to be used in conjunction with supplemental spinal fixation instrumentation. The series is comprised of cages of various sizes, and are designed to expand in height intra-operatively to accommodate variations in surgical approach and patient anatomy. Each cage has a hollow center to allow placement of autograft inside of the cage. Ridges on the superior and inferior surfaces of the device help to grip the endplates and prevent expulsion. The OmegaLIF System devices are made from Titanium alloy Ti6Al4V ELI, ASTM F136. INDICATIONS The OmegaLIF Lumbar device is indicated for intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level. OmegaLIF device is intended to be used with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage CONTRAINDICATIONS • Spondylolisthesis higher than Grade 1 (not for the use with a pedicle screw fixation system) • Reduced bone density, which does not guarantee a sufficient resting stability (e. g. osteoporosis) • Fractures • Tumors • Scoliosis • Active infection • Allergy to Titanium • Signs of local inflammation • Fever or leukocytosis • Morbid obesity • Pregnancy • Mental illness • Suspected or documented allergy or intolerance to composite materials • Any case not needing a fusion • Any case not described in the indications • Any patient unwilling to cooperate with postoperative instructions • Patients with a known hereditary or acquired bone friability or calcification problem should not be considered for this type of surgery • These devices must not be used for pediatric cases, nor where the patient still has general skeletal growth • Spondylolisthesis unable to be reduced to Grade 1 • Any case where the implant components selected for use would be too large or too small to achieve a successful result • Any case that requires the mixing of metals from two different components or systems • Any patient having inadequate tissue coverage over the operative site or inadequate bone stock or quality • Any patient in which implant utilization would interfere with anatomical structures or expected physiological performance • Prior fusion at the level to be treated LB-064  Page 1 of 9  Rev. 20211007
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