# K243116: FlareHawk Interbody Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Integrity Implants Inc. Dba Accelus
- Decided: May 21, 2025 after 233 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: 23 generations back to K841189 (1984). 363 ancestors in all.
No later device cites it as a predicate yet.
1 of 364 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202198: FlareHawk Interbody Fusion System, Integrity Implants, Inc. (2020) Summary page 7.
- K220453: FlareHawk Interbody Fusion System, Integrity Implants, Inc. (2022) Summary page 7.

## Indications for use
The 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/K243116
Methodology: https://510kreport.com/methodology