# K090425: Guided Lateral Interbody Fusion (Glif) System

- Pathway: 510(k) (Traditional)
- Applicant: Alphatec Spine, Inc.
- Decided: May 19, 2009 after 89 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: 2 generations back to K071922 (2007). 3 ancestors in all.
319 later devices descend from it; 2 cite it directly.
0 of 323 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080699: Novel Spinal Spacer System, Alphatec Spine, Inc. (2008) Summary page 2.
- K071795: Nuvasive Coroent System, Nuvasive, Inc. (2007) Summary page 2.

## Most influential descendants
- K140348: Interbody Cage (2015), 235 descendants of its own
- K163506: Coalesce™ (-Straight, -Convex, -Crescent, -Lateral, -Anterior, or -Oblique) Lumbar Interbody Fusion System (2017), 224 descendants of its own
- K100210: TRANS1 Lateral Intervertebral Fusion Device, T (2010), 175 descendants of its own
- K123997: TRANS1LATERAL Interbody Fusion System (2013), 173 descendants of its own
- K153107: Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine VEO™ Lateral Access & Interbody Fusion System, Choice Spine Interbody Fusion System (2016), 171 descendants of its own

## Indications for use
When used as an intervertebral body'fusion device, the Guided Lateral Interbody Fusion (GLIF) System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients should have had six months of non-operative treatment. The GLIF System is to be used with a supplemental fixation system and autogenous bone graft. When used as a vertebral body replacement device, the Guided Lateral Interbody Fusion (GLIF) system is intended for use in the thoracolumbar spine (Ti -L5) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e. fracture). The GLIF System is intended for use with supplemental spinal fixation system. Specifically the GLIF System is to be used with Alphatee Zodiac Polyaxial Spinal Fixation System or the Alphatec Mirage Top Tightening Spinal System. Furthermore the GLIF System is intended for use with allograft.

Source page: https://510kreport.com/device/K090425
Methodology: https://510kreport.com/methodology