# K133063: Santis Pedicle Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Lanterna Medical Technologies
- Decided: Jan 13, 2014 after 108 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: 5 generations back to K000319 (2000). 13 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091717: Any Plus Spinal Fixation System, GS Medical Co., Ltd. (2010) Summary page 2.

## Most influential descendants
- K192915: GMA 2.0 Pedicle Screw System (2019), 0 descendants of its own
- K150507: Santis Pedicle Screw System (2015), 0 descendants of its own

## Indications for use
The Santis Pedicle System is intended for immobilization and stabilization of the spine. The Santis Pedicle System is indicated for posterior, noncervical pedicle fixation as an adjunct to fusion in skeletally mature patients using autograft and/or allograft for the following indications: degenerative disc disease (ODD) (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/K133063
Methodology: https://510kreport.com/methodology