# K191810: Curiteva Pedicle Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Curiteva, Inc.
- Decided: Aug 28, 2019 after 54 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: 10 generations back to K950697 (1995). 65 ancestors in all.
No later device cites it as a predicate yet.
0 of 66 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162367: Erisma® LP MIS, Clariance, Sas (2016) Summary page 4.

## Cited in the summary but kept off the family tree
- K150896: Vitality Spinal Fixation System, Zimmer Spine, Inc. (2015). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The Curiteva Pedicle Screw System is intended for posterior, non-cervical pedicle screw fixation (T1-S2/ilium) and hook fixation (T1-L5) in skeletally mature patients as an adjunct to fusion for all of the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, stenosis, pseudarthrosis and/or failed previous fusion. The Curiteva Pedicle Screw System is intended to be used with autograft and/or allograft.

Source page: https://510kreport.com/device/K191810
Methodology: https://510kreport.com/methodology