# K250769: Dakota LP System

- Pathway: 510(k) (Traditional)
- Applicant: Precision Spine, Inc.
- Decided: Nov 24, 2025 after 256 days
- Product code: ODP (Intervertebral Fusion Device With Bone Graft, Cervical)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 27 generations back to K841189 (1984). 603 ancestors in all.
No later device cites it as a predicate yet.
1 of 604 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142218: Coalition AGX Plate and Coalition AGX Spacer, Globus Medical, Inc. (2015) Summary page 5.
- K233509: Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System, LABYRINTH System, Zavation ALIF System, Zavation Medical Products, LLC (2024) Summary page 5.
- K191243: HEDRON Cervical Spacers, Globus Medical, Inc. (2019) Summary page 5.

## Indications for use
The Dakota LP Anterior Cervical Interbody Fusion System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) at one or two disc levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. Dakota LP Anterior Cervical Interbody Fusion System implants are used to facilitate fusion in the cervical spine and are placed via an anterior approach at the C2 to T1 disc levels using autograft bone. Patients should have at least six weeks of non-operative treatment prior to treatment with an intervertebral fusion device. The device should be used with supplemental fixation.

Source page: https://510kreport.com/device/K250769
Methodology: https://510kreport.com/methodology