# K252461: Swedge™ Pedicle Screw Fixation System Bezier Rod

- Pathway: 510(k) (Traditional)
- Applicant: Spinal Resources, Inc.
- Decided: Jan 13, 2026 after 161 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: 12 generations back to K040583 (2004). 115 ancestors in all.
No later device cites it as a predicate yet.
0 of 116 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230482: Swedge™ Pedicle Screw Fixation System, Spinal Resources, Inc. (2023) Summary page 6.

## Indications for use
The Swedge TM 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 ™ Bezier rods may be used with compatible systems that use 4.75, 5.0, 5.5, and 6.0mm posterior rods made from either titanium alloy or cobalt chrome alloys. When connected to compatible systems, the Swedge TM Bezier rods are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to thoracolumbosacral fusion for 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, deformities or curvatures (i.e., scoliosis and/or kyphosis), spinal tumor, pseudoarthrosis, and failed previous fusion. Please refer to the additional information section in the Instructions for Use on compatible pedicle screw system rod requirements. The Swedge TM Pedicle Screw Fixation System is also intended for non-cervical pedicle screw fixation for the following indications: DDD ( degenerative disc disease) 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/K252461
Methodology: https://510kreport.com/methodology