# K250186: GoLIF! Lumbar Interbody Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Getset Surgical, SA
- Decided: Mar 21, 2025 after 58 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: 16 generations back to K841189 (1984). 163 ancestors in all.
No later device cites it as a predicate yet.
0 of 164 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151472: NuVasive CoRoent Lumbar System, Nu Vasive, Incorporated (2015) Summary page 5.

## Indications for use
The GetSet GoLIF! Lumbar Interbody Fusion (IBF) system is indicated for interbody fusion with autograft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft in patients with symptomatic Degenerative Disc Disease (DDD) at either one or two contiguous levels in the lumbar spine, from L1-L2 to L5-S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via an open or a minimally invasive posterior approach. Alternatively, these implants may also be implanted via a transforaminal approach. These devices are intended to be used with supplemental posterior fixation, which has been cleared by the FDA for use in the lumbar spine.

Source page: https://510kreport.com/device/K250186
Methodology: https://510kreport.com/methodology