# K211606: Mariner Deformity System

- Pathway: 510(k) (Special)
- Applicant: SeaSpine Orthopedics Corporation
- Decided: Jun 23, 2021 after 29 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K901587 (1990). 124 ancestors in all.
47 later devices descend from it; 1 cites 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 4.
- K191648: Mariner MIS Pedicle Screw System; SeaSpine Navigation System, SeaSpine Orthopedics Corporation (2019) Summary page 4.
- K122571: Malibu Spinal System with the Daytona Deformity System, Seaspine, Inc. (2012) Summary page 4.

## Most influential descendants
- 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
- K232275: Invictus® Spinal Fixation System (2023), 11 descendants of its own

## Recalls of this device
- Aug 19, 2026 · Class II · Z-3226-2026: The proximal thread depth of the spinal device is out of design specification.

## 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/K211606
Methodology: https://510kreport.com/methodology