OrthoAxis - Product

Product Overview

The Daytona® Small Stature Spinal System is designed to address standard to complex deformity cases in smaller-sized patients who need a lower profile construct due to anatomy constraints. It combines unique implant designs, materials and innovative instrumentation to create a highly flexible and intuitive system for surgeons and patients.

Key Features

Adolescent Idiopathic Scoliosis (AIS) Indication
4.5mm diameter Textured CoCr Rods, Precontoured and Straight
Screws are Self-tapping, Polyaxial and Cannulated with 30mm of built-in rod reduction
Available in the following diameters:
- 4.5mm, 5.5mm, 6.5mm, 7.5mm
Rod connectors
- 4.5mm to 4.5mm
- 4.5mm to 5.5mm
Axial Connectors
Crossbars
Hooks

Indications:
The SeaSpine Daytona Small Stature Spinal System is intended for posterior, non-cervical pedicle fixation to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine. The indications for use are as follows: Degenerative Disc Disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies; Severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion; Spondylolisthesis; Trauma (i.e., fracture or dislocation); Spinal stenosis; Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis); Spinal tumor; Pseudoarthrosis; and/or Failed previous fusion.
Except for hooks, when used as an anterolateral thoracic/lumbar system, the SeaSpine Daytona Small Stature Spinal System may be used for the above indications as an adjunct to fusion in skeletally mature patients.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Daytona Small Stature Spinal System is indicated as an adjunct to fusion in the treatment of progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including adolescent idiopathic scoliosis (AIS), neuromuscular scoliosis, and congenital scoliosis. Additionally, the Daytona Small Stature Spinal System is intended to treat pediatric patients diagnosed with spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. The devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The Daytona® Small Stature Spinal System can be attached to SeaSpine’s Atoll™ OCT Spinal System, Sierra™ Spinal System, or Malibu™ Spinal System using the rod connectors. Refer to the Atoll™, Sierra™, or Malibu™ System’s Package Insert for the indications for use for those systems.

(QF-10-01-70-ENGL-E)

Procedures:
Posterior Lumbar Fusion (https://www.seaspine.com/)

SeaSpine Orthopedics Website

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Daytona® Small Stature Spinal System

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