# K183639: Mariner Outrigger Revision System

- Pathway: 510(k) (Traditional)
- Applicant: SeaSpine Orthopedics Corporation
- Decided: May 23, 2019 after 148 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). 333 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 342 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173882: SeaSpine Mariner Pedicle Screw System, SeaSpine Orthopedics Corporation (2018) Summary page 4.
- K163604: SeaSpine® Daytona® Small Stature Spinal System, SeaSpine Orthopedics Corporation (2017) Summary page 4.
- K180686: SeaSpine Daytona Small Stature Spinal System, SeaSpine Orthopedics Corporation (2018) Summary page 4.
- K170647: Connector System, Orthofix, Inc. (2017) Summary page 4.
- K172194: Connector System, Orthofix, Inc. (2017) Summary page 4.

## Most influential descendants
- 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
- K231069: PERLA® TL Posterior Thoraco-lumbar Fixation System (2023), 1 descendant of its own

## Indications for use
When used with the Mariner, Daytona Small Stature, Malibu, Newport, and Coral Spinal Systems: The Mariner Outrigger Revision System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion as a pedicle screw fixation system (T1-S2/ilium) in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies) spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudarthrosis (i.e., failed previous fusion) When used with Daytona Small Stature Spinal System for posterior non-cervical pedicle screw fixation in pediatric patients, the Mariner Outrigger Revision System is also indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis (AIS), neuromuscular scoliosis, and congenital scoliosis. Pediatric pedicle screw fixation is limited to a posterior approach. The Mariner Outrigger Revision System is intended to be used with autograft or allograft.

Source page: https://510kreport.com/device/K183639
Methodology: https://510kreport.com/methodology