# K162066: Reliance Spinal Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Reliance Medical Systems, LLC
- Decided: Dec 2, 2016 after 129 days
- Product code: MNH (Orthosis, Spondylolisthesis Spinal Fixation)
- 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 K853033 (1985). 149 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 153 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081978: Reliance Spinal Screw System, Reliance Medical Systems, LLC (2009) Summary page 4.
- K101112: Reliance Spinal Screw System, Reliance Medical Systems (2010) Summary page 4.
- K110896: Reliance Spinal Screw System, Reliance Medical Systems, LLC (2012) Summary page 4.
- K123521: Reliance Spinal Screw System, Reliance Medical Systems, LLC (2013) Summary page 4.
- K152131: Reliance Spinal Screw System, Reliance Medical Systems, LLC (2015) Summary page 4.
- K102514: Nuvasive Spherx II -Mas Deformity Spinal System, Nuvasive, Inc. (2010) Summary page 4.

## Most influential descendants
- K210874: Reliance Spinal Screw System (2021), 2 descendants of its own
- K213750: VyLink™ Spinal Screw System (2022), 1 descendant of its own
- K231744: VyLink™ Spinal Screw System (2023), 0 descendants of its own

## Indications for use
The Reliance Spinal Screw System is a pedicle screw system intended 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: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The Reliance Spinal Screw System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion 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. When used posteriorly, the Reliance Spinal Screw System is also a hook and sacral/iliac screw fixation system of the noncervical spine indicated for spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis, and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis). Levels of fixation are for the thoracic, lumbar, and sacral spine. The Reliance Spinal Screw System when used with staples and two rods as an anterior thoracic/lumbar screw fixation system, is indicated for spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis). When used in a percutaneous, posterior approach with MIS Instrumentation, the Reliance Spinal Screw System components are intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.

Source page: https://510kreport.com/device/K162066
Methodology: https://510kreport.com/methodology