# K212692: Mariner Pedicle Screw System

- Pathway: 510(k) (Special)
- Applicant: SeaSpine Orthopedics Corporation
- Decided: Sep 21, 2021 after 27 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: 14 generations back to K901587 (1990). 126 ancestors in all.
46 later devices descend from it; 5 cite it directly.
0 of 173 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.
- K211606: Mariner Deformity System, SeaSpine Orthopedics Corporation (2021) Summary page 4.

## Most influential descendants
- 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
- K232275: Invictus® Spinal Fixation System (2023), 11 descendants of its own
- K222110: Mariner RDX System (2022), 8 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.

Source page: https://510kreport.com/device/K212692
Methodology: https://510kreport.com/methodology