# K183184: FlareHawk Interbody Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Integrity Implants, Inc.
- Decided: Apr 3, 2019 after 135 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: 19 generations back to K841189 (1984). 241 ancestors in all.
12 later devices descend from it; 5 cite it directly.
0 of 254 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133514: Xcage Interbody Fusion System, Ouroboros Medical (2014) Summary page 6.
- K160076: XCage™ Interbody Fusion System, Ouroboros Medical, Inc. (2016) Summary page 6.
- K150395: Omega LIF System, Amendia, Inc. (2015) Summary page 6.
- K160924: Amendia Interbody Fusion Devices, Amendia, Inc. (2016) Summary page 6.
- K072970: Patriot Spacers, Globus Medical, Inc. (2008) Summary page 6.
- K102293: Caliber Spacer, Globus Medical, Inc. (2011) Summary page 6.

## Most influential descendants
- K203038: Toro-L Interbody Fusion System (2021), 5 descendants of its own
- K213355: Toro-L Interbody Fusion System (2022), 4 descendants of its own
- K221894: Lumbar Expandable lnterbody Spacers -Additional Indications/Implants (2023), 2 descendants of its own
- K202198: FlareHawk Interbody Fusion System (2020), 2 descendants of its own
- K201367: FlareHawk TiHawk9 Interbody Fusion System (2020), 2 descendants of its own

## Indications for use
FlareHawk™ Interbody Fusion System is indicated for spinal intervertebral body fusion with autogenous bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone in skeletally mature individuals with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1, following discectomy. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have at least six (6) months of non-operative treatment. Additionally, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). FlareHawk™ system spacers are intended to be used with supplemental fixation instrumentation, which has been cleared for use in the lumbar spine.

Source page: https://510kreport.com/device/K183184
Methodology: https://510kreport.com/methodology