# K163604: SeaSpine® Daytona® Small Stature Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: SeaSpine Orthopedics Corporation
- Decided: Mar 9, 2017 after 78 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: 18 generations back to K040583 (2004). 212 ancestors in all.
12 later devices descend from it; 3 cite it directly.
0 of 225 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161535: SeaSpine® NewPort™ Spinal System, SeaSpine Orthopedics Corporation (2016) Summary page 4.
- 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.
- K152632: XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument Accessory, Stryker Corporation (2015) 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 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. 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.

Source page: https://510kreport.com/device/K163604
Methodology: https://510kreport.com/methodology