SPINAL elements

CLUTCH POSTERIOR FIXATION System Instructions for Use

6 Pages

Spinal Elements, Inc. · 3115 Melrose Dr., Suite 200 Carlsbad, CA 92010 · U.S.A. · 760.607.0121  CLUTCH® POSTERIOR FIXATION SYSTEM IMPLANTS AND INSTRUMENTATION  This package insert covers the Clutch® Posterior Fixation 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 Implants The Clutch® Posterior Fixation System is a posterior, non-pedicle supplemental fixation device to facilitate fusion. System components are available in a multitude of sizes and configurations so that adaptations can be made to take into account different patient anatomies. All implant components are made from titanium alloy (Ti-6Al-4V) conforming to ASTM F 136 with a nitinol spring conforming to ASTM F 2063 and a coating of commercially pure titanium conforming to ASTM F 1580. All implants are intended for single patient use only and should not be reused (used in additional patients) under any circumstances. Reuse may result in serious injury or death. Instruments Spinal Elements’ instruments are manufactured from various stainless steels, aluminums, and polymers. All materials used have a history of use in such instruments. Components from this system should not be used in conjunction with components from other systems. INDICATIONS The Clutch® Posterior Fixation System is a posterior, non-pedicle supplemental fixation device, intended for use in the noncervical spine (T1-S1) of skeletally mature patients. It is intended for single level plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), trauma (i.e. fracture or dislocation), spondylolisthesis, and/or tumor. The Clutch®Posterior Fixation System is not intended for stand-alone use. CONTRAINDICATIONS 1. Patients with known or probable intolerance to the materials used in the manufacture of this device. 2. Patients with infection, inflammation, fever, tumors, elevated white blood count, obesity, pregnancy, mental illness and other medical conditions which would prohibit beneficial surgical outcome. 3. Patients resistant to following post-operative restrictions on movement especially in athletic and occupational activities. 4. Use with components from other systems. 5. Grossly distorted anatomy caused by congenital abnormalities. 6. Any other medical or surgical condition which would preclude the potential benefit of spinal implant surgery. 7. Rapid joint disease, bone absorption, osteopenia. Osteoporosis is a relative contraindication since this condition may limit the degree of obtainable correction, stabilization, and/or the amount of mechanical fixation. 8. Any case where the implant components selected for use would be too large or too small to achieve a successful result. 9. Any patient having inadequate tissue coverage over the operative site or inadequate bone stock or quality. 10. Any patient in which implant utilization would interfere with anatomical structures or expected physiological performance. 11. Any case not needing bone graft and fusion. 12. Any case not described in the indications for use. 13. Reuse or multiple use. WARNINGS Implants and instruments are provided non-sterile. Instruments must be cleaned and sterilized before use. Implants may be processed 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 bio-contaminants 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. The safety and effectiveness of spinous process plate systems have been established for spinal conditions requiring fusion with instrumentation. These conditions include significant mechanical instability or deformity of the thoracic, lumbar, and sacral INS-ISP  Page 1 of 6  Rev. 20190823
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File Name: SPINAL elements - INS-ISP - CLUTCH POSTERIOR FIXATION System Instructions for Use - 2019-08.pdf

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