# K180686: SeaSpine Daytona Small Stature Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: SeaSpine Orthopedics Corporation
- Decided: May 14, 2018 after 60 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: 16 generations back to K040583 (2004). 151 ancestors in all.
12 later devices descend from it; 3 cite it directly.
0 of 164 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122571: Malibu Spinal System with the Daytona Deformity System, Seaspine, Inc. (2012) Summary page 4.
- K072605: Malibu Spinal System, Seaspine, Inc. (2007) Summary page 4.
- K061342: Malibu Spinal System, Seaspine, Inc. (2006) Summary page 4.
- K051942: Malibu Spinal System, Seaspine, Inc. (2005) Summary page 4.
- K051663: Malibu Spinal System, Seaspine, Inc. (2005) Summary page 4.
- K140276: CD Horizon Spinal System, Medtronic Sofamor Danek (2014) Summary page 4.

## Cited in the summary but kept off the family tree
- K163206: SMD-Sr90-DA Radionuclide Brachytherapy Source, Salutaris Medical Devices, Inc. (2016). Our reading of the summary gave K163206, FDA’s number for SMD-Sr90-DA Radionuclide Brachytherapy Source (Salutaris Medical Devices, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “SeaSpine Daytona Small Stature Spinal System”. Kept off the family tree. Summary page 4.

## Most influential descendants
- K183639: Mariner Outrigger Revision System (2019), 8 descendants of its own
- K193396: PERLA® TL posterior osteosynthesis system (2020), 7 descendants of its own
- K203222: PERLA TL Posterior Osteosynthesis System (2020), 4 descendants of its own
- K203506: PERLA® TL posterior osteosynthesis system (2021), 3 descendants of its own
- K213470: PERLA® TL Posterior Osteosynthesis System (2022), 2 descendants of its own

## Indications for use
The SeaSpine Daytona Small Stature Spinal System is intended for posterior, non-cervical 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 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.

Source page: https://510kreport.com/device/K180686
Methodology: https://510kreport.com/methodology