# K193106: SpineFrontier Lumbar Interbody Fusion Device System

- Pathway: 510(k) (Special)
- Applicant: Spinefrontier, Inc.
- Decided: Jun 19, 2020 after 224 days
- Product code: MAX (Intervertebral Fusion Device With Bone Graft, 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: 5 generations back to P950002 (1996). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142504: SpineFrontier Lumbar Interbody Fusion Device System, Spinefrontier, Inc. (2015) Summary page 5.

## Indications for use
The SpineFrontier Lumbar lnterbody Fusion Device System (Dorado IBC, Dorado PLIFT, Dorado ELIFT, Arena-L, Dorado TILT, Dorado TLIFT, Dorado Wide, and Ursa S-LIFT) is intended for intervertebral body fusion of the spine of skeletally mature patients, using autogenous bone graft to facilitate fusion. The device is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2-S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history or radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The SpineFrontier Lumbar Interbody Fusion Device System is intended to be used with supplemental spinal fixation system(s) cleared for use in the lumbar spine.

Source page: https://510kreport.com/device/K193106
Methodology: https://510kreport.com/methodology