SPINAL elements

KARMA FIXATION System Instructions for Use

6 Pages

Spinal Elements, Inc. · 3115 Melrose Dr., Suite 200 Carlsbad, CA 92010 · U.S.A. · 760.607.0121  KARMA® FIXATION SYSTEM IMPLANTS AND INSTRUMENTATION  This package insert covers the Karma 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 Karma Fixation System consists of a strap with teeth along its length that interact with a latching mechanism. The leading tip of the device is tapered and smooth to help lead the strap through or around the bony structures to be secured. The strap tip is fed through the latch and made consecutively shorter or taut by pulling the strap through the latch. Once the desired loop length is reached, the unneeded portion of the strap may be cut off and discarded. The device is made from PEEK conforming to ASTM F2026 compounded with 7.5% barium sulphate, and Tantalum conforming to ASTM F560. The implant is intended for single use only and should not be reused 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 Karma Fixation System is a temporary implant to be used in orthopedic surgery. The Karma implant is a bony anchor designed to provide temporary stabilization of the spine for bony fusion or consolidation of a fracture. Karma Fixation System is designed for a posterior approach. The indications for use include the following applications: 1. Spinal trauma surgery: Karma implants can be used in sublaminar wiring techniques; 2. Spinal degenerative surgery: Karma implants may be used as an adjunct to spinal fusions with bone graft (autograft or allograft) at level(s) of 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 inappropriate 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 and must be cleaned and sterilized prior to use. Validated sterilization cycle parameter protocols are noted in the STERILIZATION section of this insert. 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 INS-CRG  Page 1 of 6  Rev. 20210723
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File Name: SPINAL elements - INS-CRG - KARMA FIXATION System Instructions for Use - 2021-07.pdf

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