# K160902: Mariner Pedicle Screw System

- Pathway: 510(k) (Traditional)
- Applicant: SeaSpine Orthopedics Corporation
- Decided: May 26, 2016 after 55 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: 11 generations back to K901587 (1990). 55 ancestors in all.
60 later devices descend from it; 4 cite it directly.
0 of 116 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053276: Ist Pedicle Screw System, Innovative Spinal Technologies, Inc. (2005) Summary page 4.
- K051663: Malibu Spinal System, Seaspine, Inc. (2005) Summary page 4.
- K051942: Malibu Spinal System, Seaspine, Inc. (2005) Summary page 4.
- K061342: Malibu Spinal System, Seaspine, Inc. (2006) Summary page 4.
- K072605: Malibu Spinal System, Seaspine, Inc. (2007) Summary page 4.
- K043232: Ucr Spinal System, Seaspine (2004) Summary page 4.
- K021623: Ucr Spinal System, 5.5MM, 8.0MM Screws & Instruments, Iame, Inc. (2002) Summary page 4.
- K083089: Newport Spinal System, Seaspine, Inc. (2009) Summary page 4.

## Most influential descendants
- K173882: SeaSpine Mariner Pedicle Screw System (2018), 56 descendants of its own
- K191648: Mariner MIS Pedicle Screw System; SeaSpine Navigation System (2019), 49 descendants of its own
- 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

## Indications for use
The intended use of the Mariner Pedicle Screw System 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, - severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusions by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion, - spondylolisthesis, - trauma (i.e., fracture or dislocation), - spinal stenosis, - deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), - spinal tumor, - pseudoarthrosis, and/or - failed previous fusion.

Source page: https://510kreport.com/device/K160902
Methodology: https://510kreport.com/methodology