510(k) · Cleared
ClearedFlareHawk TiHawk9 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 Sep 23, 2020 as substantially equivalent to K182114 (Integrity Implants, Inc., 2019) and 5 other predicates after a 124-day review. Its family tree reaches back 21 generations to 1984. 1 of the 289 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it.
- Decided
- Sep 23, 2020
- Review
- 124 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 21 generations to K841189 (1984). 286 ancestors in all. 2 later devices descend from it, 1 citing it directly. 1 of the 289 devices in this family, counting this one, has a Class I recall.
- Root · 21 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 17 generations between
- 3 generations backK162918 Atlas Spine Expandable Interbody SystemAtlas Spine, Inc. · 2017
- 2 generations backK172696 FORZA® XP Expandable Spacer SystemOrthofix, Inc. · 2018
- 1 generation backK182114 FlareHawk Interbody Fusion SystemIntegrity Implants, Inc. · 2019
- This deviceK201367 FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc. · 2020
- Descendant · cites it directly · 1 of its ownK233509 Zavation IBF System, Zavation Varisync Plate System and Varisync…Zavation Medical Products, LLC · 2024
- Descendant · 2 generations on · 0 of its ownK250769 Dakota LP SystemPrecision Spine, Inc. · 2025
Show all 21 generations
- Root · 21 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 20 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 19 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 18 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 17 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 16 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 15 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 14 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 13 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 12 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
- 11 generations backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- 10 generations backK081849 Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc. · 2008 · Recalled
- 9 generations backK091301 Life Spine Stand-Alone Spacer SystemLife Spine · 2009
- 8 generations backK100802 Aesculap Implant Systems Sibd Spinal SystemAesculap Implant Systems, Inc. · 2010
- 7 generations backK111122 Aesculap Sibd XP Spinal SystemAesculap Implant Systems, Inc. · 2011
- 6 generations backK141942 Midline II TICentinel Spine, Inc. · 2014
- 5 generations backK150643 Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiCentinel Spine, Inc. · 2015
- 4 generations backK152475 FORZA PTC Spacer SystemOrthofix, Inc. · 2016
- 3 generations backK162918 Atlas Spine Expandable Interbody SystemAtlas Spine, Inc. · 2017
- 2 generations backK172696 FORZA® XP Expandable Spacer SystemOrthofix, Inc. · 2018
- 1 generation backK182114 FlareHawk Interbody Fusion SystemIntegrity Implants, Inc. · 2019
- This deviceK201367 FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc. · 2020
Class I recalls in this family
- K073202 Ardis Spacer6 generations back · 2008
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −21 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −20 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −19 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −18 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −17 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −16 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −15 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −14 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −13 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −12 | K080083 | Intrepid Spinal System | Medtronic Sofamor Danek | 2008 | 8 |
| −11 | K073109 | Stalif TT Intervertebral Body Fusion System | Surgicraft, Ltd. | 2008 | — |
| −10 | K081849 | Blackstone Pillar SA Partial Vertebral Body Replacement Device | Blackstone Medical, Inc. | 2008 | 1 |
| −9 | K091301 | Life Spine Stand-Alone Spacer System | Life Spine | 2009 | — |
| −8 | K100802 | Aesculap Implant Systems Sibd Spinal System | Aesculap Implant Systems, Inc. | 2010 | — |
| −7 | K111122 | Aesculap Sibd XP Spinal System | Aesculap Implant Systems, Inc. | 2011 | — |
| −6 | K141942 | Midline II TI | Centinel Spine, Inc. | 2014 | — |
| −5 | K150643 | Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-Ti | Centinel Spine, Inc. | 2015 | — |
| −4 | K152475 | FORZA PTC Spacer System | Orthofix, Inc. | 2016 | — |
| −3 | K162918 | Atlas Spine Expandable Interbody System | Atlas Spine, Inc. | 2017 | — |
| −2 | K172696 | FORZA® XP Expandable Spacer System | Orthofix, Inc. | 2018 | — |
| −1 | K182114 | FlareHawk Interbody Fusion System | Integrity Implants, Inc. | 2019 | — |
| 0 (this device) | K201367 | FlareHawk TiHawk9 Interbody Fusion System | Integrity Implants, Inc. | 2020 | — |
| +1 | K233509 | Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer… | Zavation Medical Products, LLC | 2024 | — |
| +2 | K250769 | Dakota LP System | Precision Spine, Inc. | 2025 | — |
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 | 15 | 0 |
| 2004 | 22 | 0 |
| 2005 | 17 | 0 |
| 2006 | 9 | 0 |
| 2007 | 14 | 0 |
| 2008 | 36 | 1 |
| 2009 | 28 | 0 |
| 2010 | 21 | 0 |
| 2011 | 21 | 0 |
| 2012 | 11 | 0 |
| 2013 | 17 | 0 |
| 2014 | 15 | 0 |
| 2015 | 11 | 0 |
| 2016 | 4 | 0 |
| 2019 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K182114 | FlareHawk Interbody Fusion SystemSummary page 6…strate the substantial equivalence of the subject FlareHawk Interbody Fusion System to legally marketed predicate devices, FlareHawk Interbody Fusion System, K182114 (SE 01/07/2019), is used as the primary predicate device. Integrity Implants’ FlareHawk Interbody Fusion System, K183184 (S… | 2019 |
| * | K183184 | FlareHawk Interbody Fusion SystemSummary page 6…, FlareHawk Interbody Fusion System, K182114 (SE 01/07/2019), is used as the primary predicate device. Integrity Implants’ FlareHawk Interbody Fusion System, K183184 (SE 04/03/2019), is also used as a predicate for this submission. Additionally, the following devices are being use… | 2019 |
| * | K142504 | SpineFrontier Lumbar Interbody Fusion Device SystemSummary page 6…coatings are not new and currently exist on other legally marketed lumbar interbody fusion devices: • SpineFrontier Lumbar lnterbody Fusion Device System (K142504, SE 05/13/2015) • Tyber Medical Intervertebral Body Fusion Device (K130573, SE 09/30/2013) • Alphatec Spine Batta… | 2015 |
| * | K130573 | Tyber Medical Interbody System; Acif, Alif, Plif, Tlif, DlifSummary page 6…erbody fusion devices: • SpineFrontier Lumbar lnterbody Fusion Device System (K142504, SE 05/13/2015) • Tyber Medical Intervertebral Body Fusion Device (K130573, SE 09/30/2013) • Alphatec Spine Battalion Universal Spacer System (K143740, SE 05/22/2015) • Octane Straight Int… | 2013 |
| * | K143740 | Battalion Universal Spacer SystemSummary page 6…m (K142504, SE 05/13/2015) • Tyber Medical Intervertebral Body Fusion Device (K130573, SE 09/30/2013) • Alphatec Spine Battalion Universal Spacer System (K143740, SE 05/22/2015) • Octane Straight Intervertebral Fusion Device, Ti Coated (K150152, SE 05/11/2015) X. Brief Discussi… | 2015 |
| * | K150152 | The Octane Straight Intervertebral Fusion Device, Ti CoatedSummary page 6…73, SE 09/30/2013) • Alphatec Spine Battalion Universal Spacer System (K143740, SE 05/22/2015) • Octane Straight Intervertebral Fusion Device, Ti Coated (K150152, SE 05/11/2015) X. Brief Discussion of the Non-Clinical and Clinical Tests Submitted Integrity Implants has conducted… | 2015 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K233509 | Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System… | 2024 | 1 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K073202Ardis SpacerAbbott Spine, Inc. · 2008 · 6 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 36 years and passes through 16 companies; a new generation was cleared every 12 months on median.
- 35 of the 286 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K233509 (Zavation Medical Products, LLC, 2024) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K182114.
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. 2020, 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?
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…
Read the full statement (115 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K201367 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201367: FlareHawk TiHawk9 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/K201367
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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