# K150395: Omega LIF System

- Pathway: 510(k) (Traditional)
- Applicant: Amendia, Inc.
- Decided: Aug 10, 2015 after 173 days
- Product code: MAX (Intervertebral Fusion Device With Bone Graft, Lumbar)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
24 later devices descend from it; 3 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K183184: FlareHawk Interbody Fusion System (2019), 12 descendants of its own
- K203254: Lucent 3D Spinal System (2021), 8 descendants of its own
- K203038: Toro-L Interbody Fusion System (2021), 5 descendants of its own
- K222833: Ventana™ C Spinal System (2023), 4 descendants of its own
- K213355: Toro-L Interbody Fusion System (2022), 4 descendants of its own

## Recalls of this device
- Apr 16, 2018 · Class II · Z-1912-2018: Omega LIF interbody implants labeled as having 11 degrees of lordosis was assembled using components manufactured with 4 degrees of lordosis.

## Indications for use
The Omega LIF device is indicated for intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L.2-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 I spondylolisthesis or retrolisthesis at the involved level. Omega LIF implants are to be used with autogenous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

Source page: https://510kreport.com/device/K150395
Methodology: https://510kreport.com/methodology