# K060081: Basis Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek
- Decided: Feb 13, 2006 after 34 days
- Product code: KWP (Appliance, Fixation, Spinal Interlaminal)
- Device class: 2
- Regulation: 21 CFR 888.3050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K013962 (2002). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013962: Equation Fixation System, Medtronic Sofamor Danek, Inc. (2002) Summary page 2.

## Indications for use
The BASIS™ Spinal System is intended for posterior, non-cervical fixation for the following indications: Spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion. Except for hooks, when used as an anterolateral thoracic/lumbar, or anterior cervical system, BASIS components are intended for the following indications: (1) spinal stenosis, (2) spondylolisthesis, (3) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (4) fracture, (5) pseudarthrosis, (6) tumor resection, and/or (7) failed previous fusion. When used as a vertebral body replacement, BASIS Vertebral Body Spacers are intended to be used in corpectomy procedures to aid in surgical correction and stabilization of the spine. The device is indicated for use in the thoracolumbar spine (T1-L5) to replace and restore height of a resected vertebral body or portion thereof, excised for the treatment of tumor or trauma (i.e., fracture). BASIS Vertebral Body Spacers must be used with supplemental fixation. Specifically, BASIS Vertebral Body Spacers are to be used with the Medtronic Sofamor Danek BASIS Anterior Thoracolumbar Plates, Multi-Axial Screws, or Fixed Angle Screws. Additionally, BASIS Vertebral Body Spacers are intended to be used with bone graft. Nota Bene: The BASIS Vertebral Body Spacers are not intended for cervical or posterior surgical implantation. The BASIS Anterior Cervical Plates are intended for anterior cervical intervertebral body fusions only. The BASIS Anterior Thoracolumbar Plates are intended for screw fixation/attachment to the anterolateral intervertebral bodies only.

Source page: https://510kreport.com/device/K060081
Methodology: https://510kreport.com/methodology