# K141291: Vertiform Posterior Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Next Orthosurgical
- Decided: Aug 26, 2014 after 99 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: 14 generations back to K853033 (1985). 111 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 114 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030383: Modification to Moss Miami Spinal System Polyaxial Screws, Depuyacromed (2003) Summary page 4.
- K130877: Expedium Spine System, Medos International SARL (2013) Summary page 4.
- K062685: Ebi Aray Spinal System, Ebi, L.P. (2006) Summary page 4.
- K111457: CD Horizon Spinal System, Medtronic Sofamor Danek (2011) Summary page 4.

## Most influential descendants
- K161499: VertiForm Posterior Fixation System (2016), 1 descendant of its own
- K190981: NEX-D2 Posterior Fixation System (2020), 0 descendants of its own

## Indications for use
The VertiForm 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 Vertiform 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/K141291
Methodology: https://510kreport.com/methodology