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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; trauma (i.e. fracture or dislocation); spinal stenosis; deformities or curvatures (i.e., scoliosis, and/or lordosis); spinal tumor; pseudoarthrosis; and/or failed previous fusion.

Except for hooks, when used as an anterolateral thoracic/lumbar system, the Daytona Small 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 pediatic patients, the Daytona Small Stature Spinal System is also 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 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. Pediation is limited to a posterior approach.

The Daytona Small Stature Spinal System can be attached to other cleared SeaSpine posterior fixation systems (e.g. Atoll OCT, Sierra Malibu, Daytona and Mariner Spinal Systems) using the rod connectors. Refer to the package inserts for the indications for use for those systems.

The Daytona® Small Stature Spinal System is a non-cervical spinal fixation device and instrumentation system intended for use as a posterior pedicle screw fixation system, as a posterior non-pedicle screw fixation system, or as an anterolateral fixation system. The system consists of single-use implants, including monoaxial, polyaxial, and uniplanar screws, rods, locking caps, crossbars, hooks, and connectors. All implants are manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F136 and cobalt chrome alloy (Co-28Cr-6Mo) per ASTM F1537.

The provided document is a 510(k) premarket notification for a medical device (Daytona® Small Stature Spinal System). It does not present any clinical performance data or studies for the device itself. Instead, it explicitly states:

"Clinical Testing: Not applicable. The determination of substantial equivalence is not based on an assessment of clinical performance data."

Therefore, I cannot provide the information requested regarding acceptance criteria and the study that proves the device meets the acceptance criteria, as no such study is detailed in this document.

The document focuses on demonstrating substantial equivalence to a previously cleared predicate device, primarily through:

• Similar intended use/indications for use.
• Similar technological characteristics (operating principle, design, components, materials, manufacturing, labeling).
• Non-clinical mechanical testing (per ASTM F1798) to show similar performance to the predicate.

Since no clinical study was conducted or referenced for the performance of this specific device, the other requested information (sample size, expert qualifications, ground truth, effect size, etc.) is not available within this document.

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