ZIMMER

6.0 Rods

Vitality Spinal Fixation System Instruction Manual

6 Pages

DESCRIPTION The Vitality Spinal Fixation System is a thoracolumbar and sacroiliac fixation system designed to aid in the surgical correction of several types of spinal conditions. The system consists of a variety of spinal rods, pedicle screws, hooks and connectors intended only to provide temporary stabilization during the development of a solid fusion of the spine with bone graft. The system can be rigidly locked into a variety of configurations, with each construct being customized to the patient’s anatomy. All implants are single use only and should not be reused under any circumstances. The implant system is intended to be removed after solid fusion has occurred.  Vitality® and Vital™ Spinal Fixation System 2  NON STERILE  only Key-Code: 07.02199.001 labeling.zimmerbiomet.com  Zimmer Biomet Spine, Inc. 10225 Westmoor Dr. Westminster, CO 80021 USA +1 800.447.3625 zimmerbiomet.com  Zimmer GmbH Sulzerallee 8 CH-8404 Winterthur Switzerland +41 058.854.80.00  Commonly Used Symbols for Medical Devices  Note: Refer to the individual package label for symbols applicable to the product. SYMBOL  DEFINITION Manufacturer  Refer to the Vitality Spinal Fixation System Surgical Technique Guide for additional information on how to use this device. Contact your Zimmer Biomet Spine Sales Representative or Zimmer Biomet Customer Service for a copy of the current Surgical Technique.  Date of manufacture Use by date  2  Do not re-use  2  Do not re-sterilize  Sterilize  INDICATIONS The Vitality Spinal Fixation System implants are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1‑S2/ilium), posterior hook fixation (T1‑L5), or anterolateral fixation (T8‑L5). Pedicle screw fixation is indicated for skeletally mature patients and for adolescent patients.  Do not use if package is damaged Diameter Consult instructions for use  These devices are indicated as an adjunct to fusion for all of the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis, Scheuermann’s Disease), tumor, stenosis, pseudoarthrosis and/or failed previous fusion. When used as an adjunct to fusion, the Vitality Spinal Fixation System is intended to be used with autograft and/or allograft.  Caution: Consult accompanying documents MR conditional Non-sterile  NON STERILE  O  Sterilized using ethylene oxide Sterilized using irradiation Quantity per package  In addition the Vitality Spinal Fixation System is intended for treatment of severe spondylolisthesis (Grade 3 and 4) of the L5‑S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, having implants attached to the lumbosacral spine and or ilium with removal of the implant after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3-sacrum/ilium.  Batch code Reference Authorized representative in the European Community Caution: Federal (USA) law restricts this device to sale by or on the order of a physician VITAL The Vital Spinal Fixation System is a subsystem of the Vitality Spinal Fixation System.  INSTRUCTIONS FOR USE  The system also includes instrumentation for insertion, securing and removal of the implants. All implants are made from medical grade titanium alloy; select rods are also available in medical grade cobalt chromium alloy. Implants made from medical grade titanium, medical grade titanium alloy, and medical grade cobalt chromium may be used together. Never use titanium, titanium alloy, and/or cobalt chromium with stainless steel in the same implant construct. The Vitality Spinal Fixation System is compatible with components from other cleared spinal fixation systems. See Indications below.  en  Before using a product placed on the market by Zimmer Biomet, the operating surgeon should study carefully the following recommendations, warnings and instructions, as well as the available product-specific information (e.g., product literature, written surgical technique). Zimmer Biomet is not liable for complications that may arise from the use of the device in circumstances outside of Zimmer Biomet’s control including, but not limited to, product selection and deviations from the device’s intended uses or surgical technique. Compatibility between all Zimmer Biomet Spine product lines, including acquisitions of pre-existing product lines, has not been established. Only authorized combinations of products should be used. Only use as indicated in the Instructions for Use (Package Insert) and/or the Surgical Technique.  When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Vitality System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Vitality System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach. The use of the Vitality Spinal Fixation System in skeletally mature patients may include the fixation of the Instinct® Java™ Spinal Fixation System* hooks, APEX Spinal System™* hooks, or fixation of the Universal Clamp® Spinal Fixation System* to the rods of the Vitality Spinal Fixation System. The Vitality Spinal Fixation System may also be used in skeletally immature patients when connected with the Universal Clamp Spinal Fixation System. In order to achieve additional levels of fixation in skeletally mature patients, the Vitality Spinal Fixation System may be connected to the Virage® OCT Spinal Fixation System* and the Instinct Java Spinal Fixation System offered by Zimmer Biomet Spine, using rod connectors. 07.02199.001-en REV 05 2019-11  1
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File Name: ZIMMER - 07.02199.001 - Vitality Spinal Fixation System Instruction Manual - 2019-11 - Rev 05.pdf

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