# K051039: Basis Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek USA, Inc.
- Decided: May 12, 2005 after 17 days
- Product code: KWQ (Appliance, Fixation, Spinal Intervertebral Body)
- Device class: 2
- Regulation: 21 CFR 888.3060
- 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 K792352 (1979). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K792352: Synthes Cervical Vertabrae Plates, DePuy Synthes (1979) Summary page 2.
- K802462: Synthes Spinal Implant System, Synthes (Usa) (1980) Summary page 2.
- K973854: Orion Anterior Cervical Plate System, Sofamor Danek USA,Inc. (1998) Summary page 2.
- K922543: Z-Plate Anterior Fixation System, Sofamor Danek Mfg., Inc. (1993) Summary page 2.
- K990603: Modification of the Zplate-Atl Anterior Fixation System, Danek Medical, Inc. (1999) Summary page 2.
- K023797: Laurain Dewald Anterior Fixation System, Medtronic Sofamor Danek (2002) Summary page 2.

## Indications for use
The BASIS™ anterior cervical plates 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. The BASIS™ anterior Thoracic and Lumbar plates 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 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.

Source page: https://510kreport.com/device/K051039
Methodology: https://510kreport.com/methodology