# K213750: VyLink™ Spinal Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Vy Spine, LLC
- Decided: Feb 28, 2022 after 90 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: 19 generations back to K040583 (2004). 303 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 305 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.
- K162066: Reliance Spinal Screw System, Reliance Medical Systems, LLC (2016) Summary page 4.
- K210874: Reliance Spinal Screw System, Reliance Medical Systems, LLC (2021) Summary page 4.

## Most influential descendants
- K231744: VyLink™ Spinal Screw System (2023), 0 descendants of its own

## Indications for use
The VyLink™ 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 disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The VyLink™ 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 and 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 VyLink™ 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. When used in a percutaneous, posterior approach with MIS instrumentation, the VyLink™ 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, pseudarthrosis, and failed previous fusion in skeletally-mature patients. The VyLink™ 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). The Vy Spine™ VySpan™ PCT System can also be linked to the Vy Spine™ VyLink™ Screw System using the dual diameter rods.

Source page: https://510kreport.com/device/K213750
Methodology: https://510kreport.com/methodology