510(k) · Cleared
ClearedA-CIFT SoloFuse
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spinefrontier, Inc. · OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
Cleared on Jul 17, 2015 as substantially equivalent to K131880 (Spinefrontier, Inc., 2014) after a 73-day review. Its family tree reaches back 12 generations to 1984. 8 later devices descend from it.
- Decided
- Jul 17, 2015
- Review
- 73 days
- Class
- Class II
- Product code
- OVE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K841189 (1984). 30 ancestors in all. 8 later devices descend from it, 1 citing it directly.
- Root · 12 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 8 generations between
- 3 generations backK091088 LDR Spine Cervical Interbody Fusion SystemLdr Spine USA · 2009
- 2 generations backK113559 LDR Spine Cervical Interbody Fusion Systme-Roi-C Lordotic ImplantsLdr Spine USA, Inc. · 2011
- 1 generation backK131880 Spinefrontier a-Cift Solofuse Cervical Intervertebral Fusion Device…Spinefrontier, Inc. · 2014
- This deviceK151198 A-CIFT SoloFuseSpinefrontier, Inc. · 2015
- Descendant · cites it directly · 7 of its ownK172484 A-CIFT SoloFuseSpinefrontier, Inc. · 2018 · Recalled
- Descendant · 2 generations on · 6 of its ownK222004 INTEGRATE -C Interbody Fusion SystemHappe Spine · 2023
- Descendant · 3 generations on · 4 of its ownK232150 ZSFab Cervical Interbody SystemZsfab, Inc. · 2023
- Descendant · 4 generations on · 3 of its ownK242734 ZSFab Cervical Interbody System; ZSFab Lumbar Interbody SystemZsfab · 2024
- Descendant · 5 generations on · 1 of its ownK252610 ZSFab Lumbar Interbody SystemZsfab, Inc. · 2025
Show all 12 generations
- Root · 12 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 11 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 10 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 9 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 8 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 7 generations backK033109 Ellys and Aurys Vertebral Body ReplacementsScient'X · 2004
- 6 generations backK043479 MC+ Partial VBRLdr Spine USA · 2005
- 5 generations backK080728 LDR Spine Roi-C ImplantLdr Spine USA · 2008
- 4 generations backK083857 LDR Spine Roi-C ImplantLdr Spine USA · 2009
- 3 generations backK091088 LDR Spine Cervical Interbody Fusion SystemLdr Spine USA · 2009
- 2 generations backK113559 LDR Spine Cervical Interbody Fusion Systme-Roi-C Lordotic ImplantsLdr Spine USA, Inc. · 2011
- 1 generation backK131880 Spinefrontier a-Cift Solofuse Cervical Intervertebral Fusion Device…Spinefrontier, Inc. · 2014
- This deviceK151198 A-CIFT SoloFuseSpinefrontier, Inc. · 2015
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K172484A-CIFT SoloFuseSpinefrontier, Inc. · 2018 · cites it directly7descendants
- K222004INTEGRATE -C Interbody Fusion SystemHappe Spine · 2023 · 2 generations on6descendants
- K232150ZSFab Cervical Interbody SystemZsfab, Inc. · 2023 · 3 generations on4descendants
- K242734ZSFab Cervical Interbody System; ZSFab Lumbar Interbody SystemZsfab · 2024 · 4 generations on3descendants
- K252610ZSFab Lumbar Interbody SystemZsfab, Inc. · 2025 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −11 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −10 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −9 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −8 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −7 | K033109 | Ellys and Aurys Vertebral Body Replacements | Scient'X | 2004 | — |
| −6 | K043479 | MC+ Partial VBR | Ldr Spine USA | 2005 | — |
| −5 | K080728 | LDR Spine Roi-C Implant | Ldr Spine USA | 2008 | — |
| −4 | K083857 | LDR Spine Roi-C Implant | Ldr Spine USA | 2009 | — |
| −3 | K091088 | LDR Spine Cervical Interbody Fusion System | Ldr Spine USA | 2009 | — |
| −2 | K113559 | LDR Spine Cervical Interbody Fusion Systme-Roi-C Lordotic Implants | Ldr Spine USA, Inc. | 2011 | — |
| −1 | K131880 | Spinefrontier a-Cift Solofuse Cervical Intervertebral Fusion Device System | Spinefrontier, Inc. | 2014 | — |
| 0 (this device) | K151198 | A-CIFT SoloFuse | Spinefrontier, Inc. | 2015 | — |
| +1 | K172484 | A-CIFT SoloFuse | Spinefrontier, Inc. | 2018 | 1 |
| +2 | K222004 | INTEGRATE -C Interbody Fusion System | Happe Spine | 2023 | — |
| +3 | K232150 | ZSFab Cervical Interbody System | Zsfab, Inc. | 2023 | — |
| +4 | K242734 | ZSFab Cervical Interbody System; ZSFab Lumbar Interbody System | Zsfab | 2024 | — |
| +5 | K252610 | ZSFab Lumbar Interbody System | Zsfab, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 8 | 0 |
| 2002 | 4 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2023 | 2 | 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 OVE? 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 OVE device
- #1 K241846 E3D™-C Interbody Systemscore 32.1 · 32 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K131880 | Spinefrontier a-Cift Solofuse Cervical Intervertebral Fusion Device SystemSummary page 6…K151198 - Page 2 of 2 Table 5-1 Predicate Devices 510k Number Trade or Proprietary or Model Name Manufacturer Type K131880 A-CIFT™ SoloFuse™ SpineFrontier® Primary K102547 CoRent® Small Inter… | 2014 |
| † | K102547 | Coroent Interlock System | 2011 |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K172484 | A-CIFT SoloFuse | 2018 | 7 |
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 31 years and passes through 8 companies; a new generation was cleared every 1.7 years on median.
- 3 of the 30 ancestors have a recall of any class.
- Of its descendants, K172484 (Spinefrontier, Inc., 2018) has gone furthest, with 7 descendants of its own.
- 1 other device also cites its predicate K131880.
How does its category compare?
All OVE devicesOVE Intervertebral Fusion Device With Integrated Fixation, Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · OVE
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OVE
105in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OVE
2in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OVE
132in 2025
MAUDE reports naming product code OVE, 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 | 1 | — | 0 | 0 |
| 2008 | 4 | 131 | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 4 | 210 | 0 | 2 |
| 2011 | 8 | 139 | 0 | 19 |
| 2012 | 7 | 125 | 0 | 59 |
| 2013 | 5 | 71 | 1 | 250 |
| 2014 | 11 | 168 | 1 | 150 |
| 2015 | 12 | 113 | 1 | 173 |
| 2016 | 15 | 149 | 1 | 145 |
| 2017 | 9 | 100 | 1 | 134 |
| 2018 | 7 | 105 | 0 | 210 |
| 2019 | 7 | 87 | 0 | 169 |
| 2020 | 13 | 149 | 0 | 162 |
| 2021 | 10 | 93 | 2 | 186 |
| 2022 | 10 | 144 | 0 | 200 |
| 2023 | 16 | 97 | 0 | 148 |
| 2024 | 6 | 56 | 0 | 142 |
| 2025 | 10 | 105 | 0 | 132 |
| 2026 | 13 | 66 | 0 | — |
What is it indicated for?
A-CIFT™ SoloFuse™ is intended for stand-alone use for intervertebral body fusion of the spine of skeletally mature patients, using autogenous bone graft to facilitate fusion. The A-CIFT™ SoloFuse™ system must be used with the internal bone screws for fixation. The device is indicated for use in patients with degenerative disc disease (DDD) of the cervical spine at one level from the C2-C3 disc to the C7-T1 disc. These DDD patients may also have up to…
Read the full statement (127 words)
A-CIFT™ SoloFuse™ is intended for stand-alone use for intervertebral body fusion of the spine of skeletally mature patients, using autogenous bone graft to facilitate fusion. The A-CIFT™ SoloFuse™ system must be used with the internal bone screws for fixation. The device is indicated for use in patients with degenerative disc disease (DDD) of the cervical spine at one level from the C2-C3 disc to the C7-T1 disc. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s).
Degenerative Disc Disease is defined as discogenic pain with degeneration of the disc confirmed by a history and radiographic studies. These patients should be skeletally mature and have had six (6) weeks of non-operative treatment prior to the treatment with an intervertebral spacer.
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/K151198 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151198: A-CIFT SoloFuse.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151198
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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