# K213118: Dakota ALIF System

- Pathway: 510(k) (Traditional)
- Applicant: Precision Spine, Inc.
- Decided: Apr 1, 2022 after 186 days
- Product code: OVD (Intervertebral Fusion Device With Integrated Fixation, Lumbar)
- 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: 20 generations back to K841189 (1984). 313 ancestors in all.
No later device cites it as a predicate yet.
1 of 314 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173082: Arco™-SA Lumbar Cage System, Neurostructures, Inc. (2018) Summary page 5.
- K130445: Vault Alif System, Spinal USA (2013) Summary page 5.
- K103369: Vault Alif System, Spinal USA (2011) Summary page 5.
- K173347: STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX, ACTILIF M FLX, ACTILIF L FLX and ACTILIF Lateral-Oblique FLX, Centinel Spine, Inc. (2018) Summary page 5.

## Indications for use
The Dakota ALIF System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device system is designed for use with autograft to facilitate fusion. One device is used per intervertebral space. The Dakota ALIF System is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is to be used with autogenous bone graft. Patients should have at least six months of non-operative treatment prior to treatment with a lumbar intervertebral fusion device. The Dakota ALIF System is a stand-alone system intended to be used with the bone screws provided. Hyperlordotic implants (those with a lordotic angle greater than or equal to 20°) are indicated for use with a supplemental spinal fixation system that has been cleared by the FDA for use in the lumbar spine.

Source page: https://510kreport.com/device/K213118
Methodology: https://510kreport.com/methodology