# K180626: Pedimax II - Pedicular Screw Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Gm Dos Reis Industria E Comerico Ltda.
- Decided: Feb 1, 2019 after 329 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Pedimax II – Pedicle Screw Spinal System is indicated for posterior, non-cervical fixation in skeletally mature patients. It is intended to be used as an adjunct to fusion using autograft or allograft. The device is indicated for the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

Source page: https://510kreport.com/device/K180626
Methodology: https://510kreport.com/methodology