# K190981: NEX-D2 Posterior Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Next Orthosurgical
- Decided: Jan 15, 2020 after 275 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: 16 generations back to K853033 (1985). 151 ancestors in all.
No later device cites it as a predicate yet.
0 of 152 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141291: Vertiform Posterior Fixation System, Next Orthosurgical (2014) Summary page 4.
- K161499: VertiForm Posterior Fixation System, Next Orthosurgical (2016) Summary page 4.
- K030383: Modification to Moss Miami Spinal System Polyaxial Screws, Depuyacromed (2003) Summary page 4.
- K172967: Mercury® Spinal System, Spinal Elements, Inc. (2018) Summary page 4.

## Indications for use
The NEX-D2 Posterior Fixation System is intended for posterior, non-cervical fixation in skeletally mature patients for the following conditions: degenerative disc disease (DDD), DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies, spondylolisthesis, trauma (fracture or dislocation), spinal stenosis, curvatures (scoliosis, kyphosis, lordosis), tumor, pseudarthrosis (previous failed fusion). When used as posterior non-cervical pedicle screw fixation in pediatric patients, the NEX-D2 Posterior Fixation System is intended to treat adolescent idiopathic scoliosis. The device is intended to be used with autograft and or allograft to facilitate fusion.

Source page: https://510kreport.com/device/K190981
Methodology: https://510kreport.com/methodology