SPINAL elements


9 Pages

Spinal Elements, Inc. · 3115 Melrose Dr., Suite 200 Carlsbad, CA 92010 · U.S.A. · 760.607.0121  LUMBAR SPINE IMPLANTS AND INSTRUMENTATION (LUNA® XD EXPANDABLE INTERBODY AND INSERTER, GRAFT INJECTOR AND ASSOCIATED INSTRUMENTS) This package insert covers Spinal Elements lumbar spine systems: Luna® XD Interbody Fusion System, Graft Injector, and Accessory Instruments that are used for the implantation of Luna® XD devices. Specific system information for Luna® XD Inserter (containing the Luna® XD Implant), Graft Injector, and the associated instruments are highlighted in individual sections below. LUNA XD EXPANDABLE INTERBODY GENERAL INFORMATION The Luna® XD Interbody Fusion System is comprised of an implant, disposable, and reusable instruments. The Luna® XD Implant is made of PEEK (polyetheretherketone; ASTM F2026), Nitinol (nickel titanium alloy; ASTM F2063) and tantalum (ASTM F560). INDICATIONS The Luna® XD Interbody Fusion System consists of a Luna XD Implant and associated accessories. This system is indicated for spinal fusion procedures in skeletally mature patients with symptomatic 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(s). The Luna XD Interbody Fusion System is to be used with autogenous bone graft and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft to facilitate fusion. Patients receiving the device should have had at least six months of non-operative treatment prior to receiving the Luna XD Implant. The Luna XD Interbody Fusion System is to be used with supplemental fixation. CONTRAINDICATIONS 1. Active systemic or local infection in the proposed area of surgery. 2. Involved level is a revision of a previous intervertebral fusion procedure(s). 3. Known allergy to the device materials, especially nickel. 4. Severe osteoporosis, osteopenia, and/or osteomalacia. 5. A medical condition that interferes with postoperative management program. 6. Active malignancy. 7. Morbid obesity. 8. Grade II or greater spondylolisthesis or retrolisthesis at involved spine level. 9. DDD affecting three or more spine motion segments. 10. Abnormal anticoagulation status. 11. Any condition not described in the Indications for Use. WARNINGS The user should inspect the device for damage prior to use. If the device appears damaged, do not use. If a device appears damaged, discard or return to the manufacturer. This device must be used with direct visualization. Failure to use direct visualization could result in serious patient injury. Failure to observe recommendations may contribute to serious patient injury. Always carefully prepare the disc space by using appropriate tools to remove all nucleus material and prepare the endplates for fusion. Always use Luna XD sizing paddles to determine the appropriate disc distraction height and to ensure the appropriate size of Luna XD Implant. Never attempt to advance the implant without the use of the Implant Inserter and Pusher Tool. Always use posterior fixation to supplement the Luna XD Implant. Do not use a mallet on the Inserter or any of the Luna XD Instruments. Never apply force to the Inserter when the implant outer members are fully deployed. Do not manipulate (twist, rotate or translate) the Inserter while the Implant is out of the cannula. This may break the Implant. INS-LUN  Page 1 of 9  Rev.20220718
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