Zimmer Biomet Vitality® Spinal Fixation System
- CataBlog
- Dec 31, 2017
- 3 min read
Updated: Jan 1, 2018
Vendor/Manufacturer: Zimmer Biomet
Product/Product Line: Vitality® Spinal Fixation System
FDA Regulation Medical Specialty: Orthopedic Devices - Prosthetic Devices
FDA Regulation Number: 888.3070
FDA Regulation Description Classification Name:
Pedicle Screw Spinal System
FDA Classification Product Code: NKB
FDA Classification Product Code Device Name:
Thoracolumbosacral Pedicle Screw System
SUBSTANTIALLY EQUIVALENT to the following products:
Device Description:
The Vitality Spinal Fixation System is a thoracolumbar and sacroiliac fixation system. The system consists of a variety of screw types, iliac screws, connectors and rods to achieve an implant construct as necessary for the individual case. The system includes instruments for inserting, securing and removing the implants. The implant system is intended to be removed after solid fusion has occurred.
The Vitality System implants are made from medical grade titanium alloy and 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. All implants are single use only and should not be reused under any circumstances.
The Vitality Spinal Fixation System is compatible with the Virage® OCT Spinal Fixation System Rods, Instinct® Java™ Spinal Fixation System Rods and Hooks, and Universal Clamp® Spinal Fixation System.
Indications for Use:
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.
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.
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.
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 Spine, using rod connectors.
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