# K222110: Mariner RDX System

- Pathway: 510(k) (Traditional)
- Applicant: SeaSpine Orthopedics Corporation
- Decided: Sep 7, 2022 after 51 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K901587 (1990). 127 ancestors in all.
8 later devices descend from it; 4 cite it directly.
0 of 136 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 4.
- K212692: Mariner Pedicle Screw System, SeaSpine Orthopedics Corporation (2021) Summary page 4.
- K122571: Malibu Spinal System with the Daytona Deformity System, Seaspine, Inc. (2012) Summary page 4.

## Most influential descendants
- K251804: KHEIRON® Spinal Fixation System, including patient specific K-ROD (2025), 4 descendants of its own
- K253990: KHEIRON® Spinal Fixation System, including patient specific K-ROD (2026), 2 descendants of its own
- K253721: KHEIRON® Spinal Fixation System, including patient specific K-ROD (2025), 2 descendants of its own
- K250908: Virata Spinal Fixation System (2025), 2 descendants of its own
- K260786: KHEIRON® Spinal Fixation System, including patient specific K-ROD (2026), 1 descendant of its own

## Recalls of this device
- Feb 28, 2024 · Class II · Z-1620-2024: Screw heads, of pedicle screw systems, have partial thread within the screw head that pose a risk of intraoperative cross-threading within the locking cap/screw head interface.
- Feb 15, 2024 · Class II · Z-1605-2024: Screw heads, of pedicle screw systems, have thin lead-in thread that pose a risk of intraoperative cross-threading within the locking cap/screw head interface.

## 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/K222110
Methodology: https://510kreport.com/methodology