SPINAL elements

CERES C STAND ALONE CERVICAL System Instructions for Use

5 Pages

Spinal Elements, Inc. · 3115 Melrose Dr., Suite 200 Carlsbad, CA 92010 · U.S.A. · 760.607.0121  CERES®-C STAND-ALONE CERVICAL SYSTEM IMPLANTS AND INSTRUMENTATION This package insert covers the Ceres-C Stand-Alone Cervical System and Manual Surgical Instruments that are used for the implantation of this system. GENERAL INFORMATION The Ceres-C Stand-Alone Cervical System includes a PEEK spacer conforming to ASTM F2026 with tantalum x-ray markers conforming to ASTM F560, and a titanium alloy (Ti-6Al-4V ELI) interbody plate and screws conforming to ASTM F136. The spacer component is assembled to the interbody plate and implanted anteriorly. The endplate contacting surfaces of the spacer component include serrations, and the plate component includes two holes for inserting one bone screw in each vertebral body. The plate component also includes a screw lock at each hole. The bone screws are available in a variety of diameters and lengths. The interbody plate components are available in a variety of heights. The spacer components are available in a variety of depths, widths, and heights. INDICATION The Ceres-C Stand-Alone Cervical System is a stand- alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non- operative treatment. The Ceres-C StandAlone Cervical implant should be packed with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and implanted with an anterior approach. CONTRAINDICATIONS 1. The Ceres-C Stand-Alone Cervical System is contraindicated in the presence of infection, pregnancy, metabolic disorders of calcified tissues, drug/alcohol abuse, mental illness, general neurologic conditions, immunosuppressive disorders, patients with known sensitivity to materials in the device, obesity and patients who are unwilling to restrict activities or follow medical advice. 2. Biological factors such as smoking, use of nonsteroidal anti-inflammatory agents, the use of anticoagulants, etc. all have a negative effect on bony union. Contraindications may be relative or absolute and must be carefully weighed against the patient’s entire evaluation. 3. This device is not intended for use except as indicated. 4. Prior fusion at the level(s) to be treated. WARNINGS Implants and instruments are provided non-sterile. Instruments must be cleaned and sterilized before use. Implants may be reprocessed prior to use and must be sterilized before use. Validated sterilization cycle parameter protocols are noted in the sterilization section of this insert. Implants that have come in direct contact with a patient or biocontaminants should be disposed of. Some instruments may be sharp, depending on their intended use. Care should be taken in handling such instruments to avoid injury to the user or patient. A successful result is not always achieved in every surgical case. This fact is especially true in spinal surgery where many extenuating circumstances may compromise the results. System components are temporary implants used for the correction and stabilization of the spine. Devices are intended to be used to augment the development of a spinal fusion by providing temporary stabilization. Devices are not intended to be the sole means of spinal support. Use of these products without a bone graft or in cases that develop into a non-union will not be successful. No spinal implant can withstand body loads without the support of bone. In this event, bending, loosening, disassembly and/or breakage of the device(s) will occur. Implantation of devices should be performed only by experienced surgeons with training in the use of spinal devices. This is a technically demanding procedure presenting a risk of serious injury to the patient.  LB-166  Page 1 of 5  Rev. 20210630
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