# K133743: Baxano Surgical Mis Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Baxano Surgical, Inc.
- Decided: Apr 7, 2014 after 119 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: 13 generations back to K853033 (1985). 189 ancestors in all.
No later device cites it as a predicate yet.
0 of 190 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090320: Conquest Spinal System, Life Spine (2009) Summary page 1.
- K113174: CD Horizon Spinal System, Medtronic Sofamor Danek USA, Inc. (2011) Summary page 1.

## Indications for use
The Baxano Surgical MIS Pedicle Screw System is intended for posterior, non-cervical pedicle fixation of the spine to provide immobilization and stabilization of spinal segments in skeletally-mature patients as an adjunct to fusion for the following indications: (1) Degenerative Disc Disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), (2) Spondylolisthesis, (3) Trauma (i.e. fracture or dislocation), (4) Spinal stenosis, (5) Curvatures (i.e. scoliosis, kyphosis, and/or lordosis), (6) Tumor, (7) Pseudoarthrosis and (8) Failed previous fusion.

Source page: https://510kreport.com/device/K133743
Methodology: https://510kreport.com/methodology