# K150954: Elite L Expandable Lumbar Fusion System

- Pathway: 510(k) (Special)
- Applicant: Innova Spinal Technologies, LLC
- Decided: May 7, 2015 after 28 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: 11 generations back to K841189 (1984). 32 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133459: Elite Ibf, Innova Spinal Technologies, LLC (2014) Summary page 4.
- K100175: Clydesdale Spinal System, Medtronic Sofamor Danek (2010) Summary page 4.
- K081611: Nuvasive Coroent System, Nuvasive, Inc. (2008) Summary page 4.

## Most influential descendants
- K160074: Rampart D Lumbar Interbody Fusion Device (2016), 5 descendants of its own
- K171660: Duo Lumbar Interbody Fusion Device (2017), 4 descendants of its own
- K181792: Duo™ Lumbar Interbody Fusion Device (2018), 3 descendants of its own
- K182322: Duo Lumbar Interbody Fusion Device (2018), 2 descendants of its own
- K190055: Duo Lumbar Interbody Fusion Device (2019), 1 descendant of its own

## Indications for use
The ELITE™ L Expandable Lumbar Fusion System is indicated for use as intervertebral body fusion devices in skeletally mature patients with Degenerative Disc Disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine from L2-L5. Patients should have received a minimum of six months of non-operative treatment prior to surgery. These patients may also have up to grade I spondylolisthesis or retrolisthesis at the involved level(s). These implants are intended for use with autogenous bone graft and supplemental internal fixation systems such as a pedicle screw or anterior plating system.

Source page: https://510kreport.com/device/K150954
Methodology: https://510kreport.com/methodology