# K191648: Mariner MIS Pedicle Screw System; SeaSpine Navigation System

- Pathway: 510(k) (Special)
- Applicant: SeaSpine Orthopedics Corporation
- Decided: Jul 19, 2019 after 29 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: 12 generations back to K901587 (1990). 122 ancestors in all.
49 later devices descend from it; 2 cite it directly.
0 of 172 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160902: Mariner Pedicle Screw System, SeaSpine Orthopedics Corporation (2016) Summary page 6.
- K172517: SeaSpine Navigation System, SeaSpine Orthopedics Corporation (2018) Summary page 6.

## Most influential descendants
- K211606: Mariner Deformity System (2021), 47 descendants of its own
- K212692: Mariner Pedicle Screw System (2021), 46 descendants of its own
- K220195: iFuse Bedrock Granite™ Implant System (2022), 32 descendants of its own
- K222774: iFuse Bedrock Granite® Implant System (2022), 20 descendants of its own
- K221926: Invictus® Bone Cement, Invictus Spinal Fixation System (2022), 14 descendants of its own

## Indications for use
The intended use of the Mariner Pedicle Screw System in a posterior or anterolateral approach is to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following 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 pseudarthrosis, and/or failed previous fusion. The SeaSpine Navigation System reusable instruments are intended to be used during the preparation and placement of SeaSpine screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The SeaSpine Navigation reusable instruments are specifically designed for use with the Medtronic Stealth Station System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.

Source page: https://510kreport.com/device/K191648
Methodology: https://510kreport.com/methodology