# K242069: Eminent Spine Scoliosis Deformity Pedicle Screw System

- Pathway: 510(k) (Special)
- Applicant: Eminent Spine
- Decided: Sep 3, 2024 after 50 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: 17 generations back to K853033 (1985). 346 ancestors in all.
No later device cites it as a predicate yet.
0 of 347 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100377: Diamondback Spinal System, Eminent Spine (2010) Summary page 4.
- K153453: Inertia Pedicle Screw and Deformity Correxxion System, Nexxt Spine, LLC (2016) Summary page 4.

## Indications for use
The Eminent Spine Scoliosis Deformity Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion as a pedicle screw fixation system (T1-S2/Ilium). The system is intended for posterior, pedicle fixation in skeletally mature patients for the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (DDD) (defined as back pain with discogenic origin with degeration of the disc confirmed by history and radiographophic studies), severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebrae, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, spinal stenosis, scoliosis, kyphosis, lordosis, spinal tumor, pseudoarthrosis and failed previous fusion. When used for fixation to the ilium, the offset connectors of the Eminent System must be used in conjunction with pedicle screws placed at the S1 or S2 spinal level. When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Eminent Spinal Scoliosis Deformity Pedicle Screw System is indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Eminent Spine Deformity Pedicle System is intended to treat pediatric patients diagnosed with: spondylolisthesis / spondylolysis, fracture caused by tumor and/or trauma, pseudoarthrosis, and/or failed previous fusion. This system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Source page: https://510kreport.com/device/K242069
Methodology: https://510kreport.com/methodology