510(k) · Cleared
ClearedSpinefrontier a-Cift Solofuse Cervical Intervertebral Fusion Device System
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 Jan 3, 2014 as substantially equivalent to K091088 (Ldr Spine USA, 2009) and 1 other predicate after a 192-day review. Its family tree reaches back 11 generations to 1984. 27 later devices descend from it.
- Decided
- Jan 3, 2014
- Review
- 192 days
- Class
- Class II
- Product code
- OVE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K841189 (1984). 29 ancestors in all. 27 later devices descend from it, 2 citing it directly.
- Root · 11 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 7 generations between
- 3 generations backK083857 LDR Spine Roi-C ImplantLdr Spine USA · 2009
- 2 generations backK091088 LDR Spine Cervical Interbody Fusion SystemLdr Spine USA · 2009
- 1 generation backK113559 LDR Spine Cervical Interbody Fusion Systme-Roi-C Lordotic ImplantsLdr Spine USA, Inc. · 2011
- This deviceK131880 Spinefrontier a-Cift Solofuse Cervical Intervertebral Fusion Device…Spinefrontier, Inc. · 2014
- Descendant · cites it directly · 18 of its ownK212853 Cervical Stand-Alone SystemEminent Spine, LLC · 2021
- Descendant · cites it directly · 8 of its ownK151198 A-CIFT SoloFuseSpinefrontier, Inc. · 2015
- Descendant · 2 generations on · 7 of its ownK172484 A-CIFT SoloFuseSpinefrontier, Inc. · 2018 · Recalled
- Descendant · 3 generations on · 6 of its ownK222004 INTEGRATE -C Interbody Fusion SystemHappe Spine · 2023
- Descendant · 2 generations on · 5 of its ownK223105 Tesera-K SC SystemKyocera Medical Technologies, Inc. · 2022
Show all 11 generations
- Root · 11 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 10 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 9 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 8 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 7 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 6 generations backK033109 Ellys and Aurys Vertebral Body ReplacementsScient'X · 2004
- 5 generations backK043479 MC+ Partial VBRLdr Spine USA · 2005
- 4 generations backK080728 LDR Spine Roi-C ImplantLdr Spine USA · 2008
- 3 generations backK083857 LDR Spine Roi-C ImplantLdr Spine USA · 2009
- 2 generations backK091088 LDR Spine Cervical Interbody Fusion SystemLdr Spine USA · 2009
- 1 generation backK113559 LDR Spine Cervical Interbody Fusion Systme-Roi-C Lordotic ImplantsLdr Spine USA, Inc. · 2011
- This deviceK131880 Spinefrontier a-Cift Solofuse Cervical Intervertebral Fusion Device…Spinefrontier, Inc. · 2014
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 27 · See all- K212853Cervical Stand-Alone SystemEminent Spine, LLC · 2021 · cites it directly18descendants
- K151198A-CIFT SoloFuseSpinefrontier, Inc. · 2015 · cites it directly8descendants
- K172484A-CIFT SoloFuseSpinefrontier, Inc. · 2018 · 2 generations on7descendants
- K222004INTEGRATE -C Interbody Fusion SystemHappe Spine · 2023 · 3 generations on6descendants
- K223105Tesera-K SC SystemKyocera Medical Technologies, Inc. · 2022 · 2 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −10 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −9 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −8 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −7 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −6 | K033109 | Ellys and Aurys Vertebral Body Replacements | Scient'X | 2004 | — |
| −5 | K043479 | MC+ Partial VBR | Ldr Spine USA | 2005 | — |
| −4 | K080728 | LDR Spine Roi-C Implant | Ldr Spine USA | 2008 | — |
| −3 | K083857 | LDR Spine Roi-C Implant | Ldr Spine USA | 2009 | — |
| −2 | K091088 | LDR Spine Cervical Interbody Fusion System | Ldr Spine USA | 2009 | — |
| −1 | K113559 | LDR Spine Cervical Interbody Fusion Systme-Roi-C Lordotic Implants | Ldr Spine USA, Inc. | 2011 | — |
| 0 (this device) | K131880 | Spinefrontier a-Cift Solofuse Cervical Intervertebral Fusion Device System | Spinefrontier, Inc. | 2014 | — |
| +1 | K212853 | Cervical Stand-Alone System | Eminent Spine, LLC | 2021 | — |
| +1 | K151198 | A-CIFT SoloFuse | Spinefrontier, Inc. | 2015 | — |
| +2 | K172484 | A-CIFT SoloFuse | Spinefrontier, Inc. | 2018 | 1 |
| +3 | K222004 | INTEGRATE -C Interbody Fusion System | Happe Spine | 2023 | — |
| +2 | K223105 | Tesera-K SC System | Kyocera Medical Technologies, Inc. | 2022 | — |
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 |
|---|---|---|
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 4 | 0 |
| 2024 | 5 | 0 |
| 2025 | 6 | 0 |
| 2026 | 6 | 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 |
|---|---|---|---|
| * | K091088 | LDR Spine Cervical Interbody Fusion SystemSummary page 2…have a successful history of use in the spinal implant industry and use of it in these devices does not introduce any previously unaccepted patient risks. The LDR ROI-C (K091088, KI 13559) and NuVasive CoRoent (K102547) aremanufactured from PEEK-OPTIMA®R LTlIand titanium alloy along with Tantalum markers.… | 2009 |
| * | K113559 | LDR Spine Cervical Interbody Fusion Systme-Roi-C Lordotic Implants | 2011 |
| † | K102547 | Coroent Interlock System | 2011 |
What descends from it? (27)
See all 272 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 30 years and passes through 8 companies; a new generation was cleared every 1.7 years on median.
- 3 of the 29 ancestors have a recall of any class.
- Of its descendants, K212853 (Eminent Spine, LLC, 2021) has gone furthest, with 18 descendants of its own.
- 50 other devices also cite its predicate K091088.
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. 2014, 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-CIFr~m SoloFuseTrM 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'm SoloFuseTM 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-TI disc. These DDD patients may also have up…
Read the full statement (127 words)
A-CIFr~m SoloFuseTrM 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'm SoloFuseTM 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-TI disc. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthcsis 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 bad six (6) weeks 6f non-operative treatment prior to the treatment with an intervertebral spacer.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131880 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131880: Spinefrontier a-Cift Solofuse Cervical Intervertebral Fusion Device System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131880
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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