# K200381: Daytona® Small Stature Spinal System

- Pathway: 510(k) (Special)
- Applicant: SeaSpine Orthopedics Corporation
- Decided: Feb 28, 2020 after 10 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 19 generations back to K040583 (2004). 214 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 217 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180686: SeaSpine Daytona Small Stature Spinal System, SeaSpine Orthopedics Corporation (2018) Summary page 4.
- K163604: SeaSpine® Daytona® Small Stature Spinal System, SeaSpine Orthopedics Corporation (2017) Summary page 4.

## Most influential descendants
- K232566: NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System; Mariner Pedicle Screw Systems: Mariner Outrigger Revision System; Mariner MIS Pedicle Screw System; Mariner Deformity System; Mariner RDX System (2024), 1 descendant of its own
- K253420: Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody System; Vu Mesh; WaveForm A Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody Sy (2026), 0 descendants of its own

## Indications for use
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; 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 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 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 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 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.

Source page: https://510kreport.com/device/K200381
Methodology: https://510kreport.com/methodology