510(k) · Cleared
ClearedFlareHawk Interbody Fusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Integrity Implants, Inc. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Apr 3, 2019 as substantially equivalent to K133514 (Ouroboros Medical, 2014) and 5 other predicates after a 135-day review. Its family tree reaches back 19 generations to 1984. 12 later devices descend from it.
- Decided
- Apr 3, 2019
- Review
- 135 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 19 generations to K841189 (1984). 241 ancestors in all. 12 later devices descend from it, 5 citing it directly.
- Root · 19 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 15 generations between
- 3 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 2 generations backK150788 Talos Intervertebral Body Fusion Devices, Talos -C Cervical…Meditech Spine, LLC · 2015
- 1 generation backK160924 Amendia Interbody Fusion DevicesAmendia, Inc. · 2016
- This deviceK183184 FlareHawk Interbody Fusion SystemIntegrity Implants, Inc. · 2019
- Descendant · cites it directly · 5 of its ownK203038 Toro-L Interbody Fusion SystemIntegrity Implants, Inc. · 2021
- Descendant · cites it directly · 4 of its ownK213355 Toro-L Interbody Fusion SystemIntegrity Implants, Inc. · 2022
- Descendant · 2 generations on · 2 of its ownK221894 Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc. · 2023
- Descendant · cites it directly · 2 of its ownK202198 FlareHawk Interbody Fusion SystemIntegrity Implants, Inc. · 2020
- Descendant · cites it directly · 2 of its ownK201367 FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc. · 2020
Show all 19 generations
- Root · 19 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 18 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 17 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 16 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 15 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 14 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 13 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 12 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 11 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 10 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 9 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 8 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 7 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 6 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 5 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 4 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 3 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 2 generations backK150788 Talos Intervertebral Body Fusion Devices, Talos -C Cervical…Meditech Spine, LLC · 2015
- 1 generation backK160924 Amendia Interbody Fusion DevicesAmendia, Inc. · 2016
- This deviceK183184 FlareHawk Interbody Fusion SystemIntegrity Implants, Inc. · 2019
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc. · 2021 · cites it directly5descendants
- K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc. · 2022 · cites it directly4descendants
- K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc. · 2023 · 2 generations on2descendants
- K202198FlareHawk Interbody Fusion SystemIntegrity Implants, Inc. · 2020 · cites it directly2descendants
- K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc. · 2020 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −19 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −18 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −17 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −16 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −15 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −14 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −13 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −12 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −11 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −10 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −9 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −8 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −7 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −6 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −5 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −4 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −3 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −2 | K150788 | Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral… | Meditech Spine, LLC | 2015 | — |
| −1 | K160924 | Amendia Interbody Fusion Devices | Amendia, Inc. | 2016 | — |
| 0 (this device) | K183184 | FlareHawk Interbody Fusion System | Integrity Implants, Inc. | 2019 | — |
| +1 | K203038 | Toro-L Interbody Fusion System | Integrity Implants, Inc. | 2021 | — |
| +1 | K213355 | Toro-L Interbody Fusion System | Integrity Implants, Inc. | 2022 | — |
| +2 | K221894 | Lumbar Expandable lnterbody Spacers -Additional Indications/Implants | Globus Medical, Inc. | 2023 | — |
| +1 | K202198 | FlareHawk Interbody Fusion System | Integrity Implants, Inc. | 2020 | — |
| +1 | K201367 | FlareHawk TiHawk9 Interbody Fusion System | Integrity Implants, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 10 | 0 |
| 2002 | 8 | 0 |
| 2003 | 14 | 0 |
| 2004 | 22 | 0 |
| 2005 | 16 | 0 |
| 2006 | 7 | 0 |
| 2007 | 11 | 0 |
| 2008 | 35 | 0 |
| 2009 | 24 | 0 |
| 2010 | 15 | 0 |
| 2011 | 16 | 0 |
| 2012 | 9 | 0 |
| 2013 | 12 | 0 |
| 2014 | 10 | 0 |
| 2015 | 6 | 0 |
| 2016 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 2 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MAX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MAX device
- #1 K203714 NuVasive Thoracolumbar Interbody Systems…score 102.5 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (6)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K133514 | Xcage Interbody Fusion SystemSummary page 6…stantial equivalence of the subject FlareHawk™ Interbody Fusion System to legally marketed predicate devices, FlareHawk™ Interbody Fusion System, K133514 (SE 05/01/2014) and K160076 (SE 10/13/2016), is used as the primary predicate device. Additional predica… | 2014 |
| * | K160076 | XCage™ Interbody Fusion SystemSummary page 6…subject FlareHawk™ Interbody Fusion System to legally marketed predicate devices, FlareHawk™ Interbody Fusion System, K133514 (SE 05/01/2014) and K160076 (SE 10/13/2016), is used as the primary predicate device. Additional predicates are Amendia/Spinal Eleme… | 2016 |
| * | K150395 | Omega LIF SystemSummary page 6…2014) and K160076 (SE 10/13/2016), is used as the primary predicate device. Additional predicates are Amendia/Spinal Elements’ OmegaLIF™ System, K150395 (SE 08/10/2015) and K160924 (SE 11/08/2016), Globus Medical’s PATRIOT® Spacers, K072970 (SE 01/18/2008),… | 2015 |
| * | K160924 | Amendia Interbody Fusion DevicesSummary page 6…ed as the primary predicate device. Additional predicates are Amendia/Spinal Elements’ OmegaLIF™ System, K150395 (SE 08/10/2015) and K160924 (SE 11/08/2016), Globus Medical’s PATRIOT® Spacers, K072970 (SE 01/18/2008), and Globus Medical’s CALIBER® Spacers K1… | 2016 |
| * | K072970 | Patriot SpacersSummary page 6…predicates are Amendia/Spinal Elements’ OmegaLIF™ System, K150395 (SE 08/10/2015) and K160924 (SE 11/08/2016), Globus Medical’s PATRIOT® Spacers, K072970 (SE 01/18/2008), and Globus Medical’s CALIBER® Spacers K102293 (SE 01/05/2011). X. Brief Discussion of the… | 2008 |
| * | K102293 | Caliber SpacerSummary page 6…95 (SE 08/10/2015) and K160924 (SE 11/08/2016), Globus Medical’s PATRIOT® Spacers, K072970 (SE 01/18/2008), and Globus Medical’s CALIBER® Spacers K102293 (SE 01/05/2011). X. Brief Discussion of the Non-Clinical Tests Submitted Mechanical testing wa… | 2011 |
What descends from it? (12)
See all 125 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 35 years and passes through 14 companies; a new generation was cleared every 11 months on median.
- 28 of the 241 ancestors have a recall of any class.
- Of its descendants, K203038 (Integrity Implants, Inc., 2021) has gone furthest, with 5 descendants of its own.
- 2 other devices also cite its predicate K133514.
How does its category compare?
All MAX devicesMAX Intervertebral Fusion Device With Bone Graft, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · MAX
29in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MAX
85in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MAX
5in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · MAX
811in 2025
MAUDE reports naming product code MAX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 7 | 86 | 0 | 12 |
| 2008 | 35 | 88 | 2 | 19 |
| 2009 | 31 | 102 | 9 | 90 |
| 2010 | 29 | 137 | 0 | 154 |
| 2011 | 49 | 98 | 3 | 201 |
| 2012 | 48 | 69 | 11 (1) | 327 |
| 2013 | 58 | 102 | 0 | 380 |
| 2014 | 58 | 115 | 3 | 366 |
| 2015 | 53 | 113 | 1 | 524 |
| 2016 | 64 | 124 | 6 | 647 |
| 2017 | 76 | 116 | 1 | 596 |
| 2018 | 64 | 114 | 4 | 616 |
| 2019 | 60 | 131 | 1 | 699 |
| 2020 | 56 | 106 | 0 | 640 |
| 2021 | 53 | 109 | 0 | 622 |
| 2022 | 41 | 95 | 1 | 618 |
| 2023 | 30 | 87 | 0 | 576 |
| 2024 | 38 | 91 | 1 | 729 |
| 2025 | 29 | 85 | 5 | 811 |
| 2026 | 18 | 95 | 0 | — |
What is it indicated for?
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…
Read the full statement (114 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183184 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183184: FlareHawk Interbody Fusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183184
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026