# K212937: Dakota ALIF Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Precision Spine, Inc.
- Decided: Nov 4, 2021 after 50 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: 6 generations back to K922543 (1993). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091044: Spinal Usa Anterior Lumbar Plate System, Spinal USA (2009) Summary page 5.
- K070922: Modification to Spinal Usa VBR System, Spinal USA (2007) Summary page 5.
- K080429: Modificaton to: Pyramid +4 Anterior Lumbar Plate System, Medtronic Sofamor Danek USA, Inc. (2008) Summary page 5.

## Indications for use
The Dakota ALIF Plate System is indicated for use as an anteriorly placed supplemental fixation device via the lateral or anterolateral surgical approach above the bifurcation of the great vessel or via the anterior surgical approach, below the bifurcation of the great vessels. The device is intended as a temporary fixation device until fusion is achieved. The Dakota ALIF Plate System is intended for anterior lumbar (L1-S1) fixation for the following indications: degenerative disc disease (DDD), 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), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

Source page: https://510kreport.com/device/K212937
Methodology: https://510kreport.com/methodology