# K230482: Swedge™ Pedicle Screw Fixation System

- Pathway: 510(k) (Special)
- Applicant: Spinal Resources, Inc.
- Decided: Mar 23, 2023 after 29 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 K040583 (2004). 114 ancestors in all.
1 later device descends from it; 1 cites 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)
- K170045: Swedge™ Pedicle Screw Fixation System, Spinal Resources, Inc. (2017) Summary page 5.
- K121342: Xia 4.5 Spinal System, Stryker Corp. (2012) Summary page 5.

## Most influential descendants
- K252461: Swedge™ Pedicle Screw Fixation System Bezier Rod (2026), 0 descendants of its own

## Indications for use
The Swedge™ Pedicle Screw Fixation System is 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 thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), spinal tumor, pseudoarthrosis and failed previous fusion. The Swedge™ Pedicle Screw Fixation System is also intended for non-cervical pedicle screw fixation for the following indications: 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. It is also intended for the following indications: DDD (degenerative disc disease); trauma (i.e. fracture or dislocation); spinal stenosis; deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor; pseudoarthrosis; and failed previous fusion.

Source page: https://510kreport.com/device/K230482
Methodology: https://510kreport.com/methodology