510(k) · Cleared
ClearedINTEGRATE -C Interbody Fusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Happe Spine · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on Apr 28, 2023 as substantially equivalent to K173030 (Nu Vasive, Incorporated, 2017) and 2 other predicates after a 295-day review. Its family tree reaches back 16 generations to 1984. 6 later devices descend from it.
- Decided
- Apr 28, 2023
- Review
- 295 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 16 generations to K841189 (1984). 81 ancestors in all. 6 later devices descend from it, 2 citing it directly.
- Root · 16 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 12 generations between
- 3 generations backK150362 NuVasive CoRoent Small Interbody SystemNu Vasive, Incorporated · 2015
- 2 generations backK163491 NuVasive CoRoent Small Interbody SystemNu Vasive, Incorporated · 2017
- 1 generation backK173030 Vertera Spine Cohere Cervical Interbody Fusion DeviceNu Vasive, Incorporated · 2017
- This deviceK222004 INTEGRATE -C Interbody Fusion SystemHappe Spine · 2023
- Descendant · cites it directly · 4 of its ownK232150 ZSFab Cervical Interbody SystemZsfab, Inc. · 2023
- Descendant · 2 generations on · 3 of its ownK242734 ZSFab Cervical Interbody System; ZSFab Lumbar Interbody SystemZsfab · 2024
- Descendant · 3 generations on · 1 of its ownK252610 ZSFab Lumbar Interbody SystemZsfab, Inc. · 2025
- Descendant · 3 generations on · 0 of its ownK261451 ZSAlign Cervical Interbody SystemZSFab, Inc. · 2026
- Descendant · 3 generations on · 0 of its ownK260549 ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, Inc. · 2026
Show all 16 generations
- Root · 16 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 15 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 14 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 13 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 12 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 11 generations backK033109 Ellys and Aurys Vertebral Body ReplacementsScient'X · 2004
- 10 generations backK043479 MC+ Partial VBRLdr Spine USA · 2005
- 9 generations backK080728 LDR Spine Roi-C ImplantLdr Spine USA · 2008
- 8 generations backK083857 LDR Spine Roi-C ImplantLdr Spine USA · 2009
- 7 generations backK091088 LDR Spine Cervical Interbody Fusion SystemLdr Spine USA · 2009
- 6 generations backK123206 Maxim Surgical X-Treme Interbody Fusion SystemMaxim Surgical · 2013
- 5 generations backK140003 Coroent Small Interbody SystemNuvasive, Inc. · 2014
- 4 generations backK140921 Coroent Small Interbody SystemNu Vasive, Incorporated · 2014
- 3 generations backK150362 NuVasive CoRoent Small Interbody SystemNu Vasive, Incorporated · 2015
- 2 generations backK163491 NuVasive CoRoent Small Interbody SystemNu Vasive, Incorporated · 2017
- 1 generation backK173030 Vertera Spine Cohere Cervical Interbody Fusion DeviceNu Vasive, Incorporated · 2017
- This deviceK222004 INTEGRATE -C Interbody Fusion SystemHappe Spine · 2023
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K232150ZSFab Cervical Interbody SystemZsfab, Inc. · 2023 · cites it directly4descendants
- K242734ZSFab Cervical Interbody System; ZSFab Lumbar Interbody SystemZsfab · 2024 · 2 generations on3descendants
- K252610ZSFab Lumbar Interbody SystemZsfab, Inc. · 2025 · 3 generations on1descendant
- K261451ZSAlign Cervical Interbody SystemZSFab, Inc. · 2026 · 3 generations on0descendants
- K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, Inc. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −15 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −14 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −13 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −12 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −11 | K033109 | Ellys and Aurys Vertebral Body Replacements | Scient'X | 2004 | — |
| −10 | K043479 | MC+ Partial VBR | Ldr Spine USA | 2005 | — |
| −9 | K080728 | LDR Spine Roi-C Implant | Ldr Spine USA | 2008 | — |
| −8 | K083857 | LDR Spine Roi-C Implant | Ldr Spine USA | 2009 | — |
| −7 | K091088 | LDR Spine Cervical Interbody Fusion System | Ldr Spine USA | 2009 | — |
| −6 | K123206 | Maxim Surgical X-Treme Interbody Fusion System | Maxim Surgical | 2013 | — |
| −5 | K140003 | Coroent Small Interbody System | Nuvasive, Inc. | 2014 | — |
| −4 | K140921 | Coroent Small Interbody System | Nu Vasive, Incorporated | 2014 | — |
| −3 | K150362 | NuVasive CoRoent Small Interbody System | Nu Vasive, Incorporated | 2015 | — |
| −2 | K163491 | NuVasive CoRoent Small Interbody System | Nu Vasive, Incorporated | 2017 | — |
| −1 | K173030 | Vertera Spine Cohere Cervical Interbody Fusion Device | Nu Vasive, Incorporated | 2017 | — |
| 0 (this device) | K222004 | INTEGRATE -C Interbody Fusion System | Happe Spine | 2023 | — |
| +1 | K232150 | ZSFab Cervical Interbody System | Zsfab, Inc. | 2023 | — |
| +2 | K242734 | ZSFab Cervical Interbody System; ZSFab Lumbar Interbody System | Zsfab | 2024 | — |
| +3 | K252610 | ZSFab Lumbar Interbody System | Zsfab, Inc. | 2025 | — |
| +3 | K261451 | ZSAlign Cervical Interbody System | ZSFab, Inc. | 2026 | — |
| +3 | K260549 | ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System | Zsfab, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 8 | 0 |
| 2002 | 5 | 0 |
| 2003 | 1 | 0 |
| 2004 | 4 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 6 | 0 |
| 2008 | 9 | 0 |
| 2009 | 7 | 0 |
| 2011 | 5 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 6 | 0 |
| 2015 | 2 | 0 |
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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 ODP? 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 ODP device
- #1 K222276 CONDUIT Cages; FIBERGRAFT BG Puttyscore 53.4 · 25 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K173030 | Vertera Spine Cohere Cervical Interbody Fusion DeviceSummary page 5…510k Number Trade or Proprietary or Manufacturer Product Predicate Model Name Code Type K173030 Cohere® Vertera Spine™ ODP Primary K133784 Vista®-S Zimmer T… | 2017 |
| * | K133784 | Vista-S Device, Associated InstrumentationSummary page 5…te Model Name Code Type K173030 Cohere® Vertera Spine™ ODP Primary K133784 Vista®-S Zimmer Trabecular Metal ODP Additional Techn… | 2014 |
| * | K172484 | A-CIFT SoloFuseSummary page 5…ODP Primary K133784 Vista®-S Zimmer Trabecular Metal ODP Additional Technology, Inc K172484 A-CIFT™ SoloFuse™ SpineFrontier (LESpine) ODP, OVE Additional K191581 Endoskeleton® TL Titan… | 2018 |
| † | K191581 | Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion… | 2020 |
What descends from it? (6)
2 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 39 years and passes through 10 companies; a new generation was cleared every 1.3 years on median.
- 9 of the 81 ancestors have a recall of any class.
- Of its descendants, K232150 (Zsfab, Inc., 2023) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K173030.
How does its category compare?
All ODP devicesODP Intervertebral Fusion Device With Bone Graft, Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · ODP
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ODP
87in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ODP
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ODP
57in 2025
MAUDE reports naming product code ODP, 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 | 0 | — | 0 | 0 |
| 2008 | 8 | 89 | 0 | 2 |
| 2009 | 12 | 127 | 1 | 21 |
| 2010 | 9 | 151 | 0 | 54 |
| 2011 | 25 | 113 | 1 | 38 |
| 2012 | 17 | 93 | 0 | 92 |
| 2013 | 18 | 187 | 1 | 78 |
| 2014 | 26 | 118 | 0 | 43 |
| 2015 | 24 | 180 | 0 | 51 |
| 2016 | 17 | 112 | 0 | 37 |
| 2017 | 33 | 104 | 0 | 39 |
| 2018 | 25 | 133 | 0 | 51 |
| 2019 | 22 | 92 | 0 | 141 |
| 2020 | 14 | 89 | 1 | 86 |
| 2021 | 18 | 121 | 0 | 161 |
| 2022 | 12 | 92 | 0 | 50 |
| 2023 | 34 | 165 | 0 | 36 |
| 2024 | 10 | 76 | 0 | 55 |
| 2025 | 11 | 87 | 2 | 57 |
| 2026 | 19 | 117 | 0 | — |
What is it indicated for?
The INTEGRATE™-C Interbody Fusion System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The INTEGRATE™-C Interbody Fusion System is intended for use for anterior cervical interbody fusion in patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2…
Read the full statement (139 words)
The INTEGRATE™-C Interbody Fusion System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The INTEGRATE™-C Interbody Fusion System is intended for use for anterior cervical interbody fusion in patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 - T1. The INTEGRATE™-C Interbody Fusion System is intended to be used with supplemental fixation. The INTEGRATE™-C Interbody Fusion System is designed for use with autograft or allogenic bone graft comprising cancellous and/or corticocancellous bone graft and/or demineralized allograft bone with bone marrow aspirate as an adjunct to fusion. Nonoperative treatment prior to treatment with INTEGRATE™-C Interbody Fusion System is six (6) weeks. INTEGRATE™-C Interbody Fusion Systems are to be implemented via an open anterior approach.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222004 · printed Nov 3, 2026
Cite this page
510(k) Report. “K222004: INTEGRATE -C Interbody Fusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K222004
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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