510(k) · Cleared
Recalled · Class II · 2019A-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 May 8, 2018 as substantially equivalent to K151198 (Spinefrontier, Inc., 2015) and 1 other predicate after a 264-day review. Its family tree reaches back 13 generations to 1984. 7 later devices descend from it. It has been recalled once.
- Decided
- May 8, 2018
- Review
- 264 days
- Class
- Class II
- Product code
- OVE
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 13 generations to K841189 (1984). 42 ancestors in all. 7 later devices descend from it, 1 citing it directly.
- Root · 13 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 9 generations between
- 3 generations backK113559 LDR Spine Cervical Interbody Fusion Systme-Roi-C Lordotic ImplantsLdr Spine USA, Inc. · 2011
- 2 generations backK131880 Spinefrontier a-Cift Solofuse Cervical Intervertebral Fusion Device…Spinefrontier, Inc. · 2014
- 1 generation backK151198 A-CIFT SoloFuseSpinefrontier, Inc. · 2015
- This deviceK172484 A-CIFT SoloFuseSpinefrontier, Inc. · 2018
- Descendant · cites it directly · 6 of its ownK222004 INTEGRATE -C Interbody Fusion SystemHappe Spine · 2023
- Descendant · 2 generations on · 4 of its ownK232150 ZSFab Cervical Interbody SystemZsfab, Inc. · 2023
- Descendant · 3 generations on · 3 of its ownK242734 ZSFab Cervical Interbody System; ZSFab Lumbar Interbody SystemZsfab · 2024
- Descendant · 4 generations on · 1 of its ownK252610 ZSFab Lumbar Interbody SystemZsfab, Inc. · 2025
- Descendant · 4 generations on · 0 of its ownK261451 ZSAlign Cervical Interbody SystemZSFab, Inc. · 2026
Show all 13 generations
- Root · 13 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 12 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 11 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 10 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 9 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 8 generations backK033109 Ellys and Aurys Vertebral Body ReplacementsScient'X · 2004
- 7 generations backK043479 MC+ Partial VBRLdr Spine USA · 2005
- 6 generations backK080728 LDR Spine Roi-C ImplantLdr Spine USA · 2008
- 5 generations backK083857 LDR Spine Roi-C ImplantLdr Spine USA · 2009
- 4 generations backK091088 LDR Spine Cervical Interbody Fusion SystemLdr Spine USA · 2009
- 3 generations backK113559 LDR Spine Cervical Interbody Fusion Systme-Roi-C Lordotic ImplantsLdr Spine USA, Inc. · 2011
- 2 generations backK131880 Spinefrontier a-Cift Solofuse Cervical Intervertebral Fusion Device…Spinefrontier, Inc. · 2014
- 1 generation backK151198 A-CIFT SoloFuseSpinefrontier, Inc. · 2015
- This deviceK172484 A-CIFT SoloFuseSpinefrontier, Inc. · 2018
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K222004INTEGRATE -C Interbody Fusion SystemHappe Spine · 2023 · cites it directly6descendants
- K232150ZSFab Cervical Interbody SystemZsfab, Inc. · 2023 · 2 generations on4descendants
- K242734ZSFab Cervical Interbody System; ZSFab Lumbar Interbody SystemZsfab · 2024 · 3 generations on3descendants
- K252610ZSFab Lumbar Interbody SystemZsfab, Inc. · 2025 · 4 generations on1descendant
- K261451ZSAlign Cervical Interbody SystemZSFab, Inc. · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −12 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −11 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −10 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −9 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −8 | K033109 | Ellys and Aurys Vertebral Body Replacements | Scient'X | 2004 | — |
| −7 | K043479 | MC+ Partial VBR | Ldr Spine USA | 2005 | — |
| −6 | K080728 | LDR Spine Roi-C Implant | Ldr Spine USA | 2008 | — |
| −5 | K083857 | LDR Spine Roi-C Implant | Ldr Spine USA | 2009 | — |
| −4 | K091088 | LDR Spine Cervical Interbody Fusion System | Ldr Spine USA | 2009 | — |
| −3 | K113559 | LDR Spine Cervical Interbody Fusion Systme-Roi-C Lordotic Implants | Ldr Spine USA, Inc. | 2011 | — |
| −2 | K131880 | Spinefrontier a-Cift Solofuse Cervical Intervertebral Fusion Device System | Spinefrontier, Inc. | 2014 | — |
| −1 | K151198 | A-CIFT SoloFuse | Spinefrontier, Inc. | 2015 | — |
| 0 (this device) | K172484 | A-CIFT SoloFuse | Spinefrontier, Inc. | 2018 | — |
| +1 | K222004 | INTEGRATE -C Interbody Fusion System | Happe Spine | 2023 | — |
| +2 | K232150 | ZSFab Cervical Interbody System | Zsfab, Inc. | 2023 | — |
| +3 | K242734 | ZSFab Cervical Interbody System; ZSFab Lumbar Interbody System | Zsfab | 2024 | — |
| +4 | K252610 | ZSFab Lumbar Interbody System | Zsfab, Inc. | 2025 | — |
| +4 | K261451 | ZSAlign Cervical 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 | 4 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (2)
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 |
|---|---|---|---|
| * | K151198 | A-CIFT SoloFuseSummary page 5…Predicate Trade or Proprietary or Model Name Manufacturer Number Type K151198 A-CIFT™ SoloFuse™ SpineFrontier Primary K142026 Arena-C® HA PEEK Cervical IBFD… | 2015 |
| * | K142026 | Spinefrontier Arena-C HA Peek Cervical Intervertebral Body Fusion DeviceSummary page 5…Number Type K151198 A-CIFT™ SoloFuse™ SpineFrontier Primary K142026 Arena-C® HA PEEK Cervical IBFD SpineFrontier Additional PERFORMANCE TESTING SUMMARY No performance testing… | 2014 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K222004 | INTEGRATE -C Interbody Fusion System | 2023 | 6 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 13, 2019 | Class II | Z-1973-2019 | Process control | There is a potential for the driver to bind up when attempting to advance the intervertebral body fixation screw. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 34 years and passes through 8 companies; a new generation was cleared every 1.7 years on median.
- 7 of the 42 ancestors have a recall of any class.
- Of its descendants, K222004 (Happe Spine, 2023) has gone furthest, with 6 descendants of its own.
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. 2018, 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 as stated in the FDA summary.
https://510kreport.com/device/K172484 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172484: 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/K172484
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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