510(k) · Cleared
ClearedSCARLET® AC-Ti
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spineart SA · OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
Cleared on May 10, 2024 as substantially equivalent to K141314 (Spineart, 2014) and 8 other predicates after a 57-day review. Its family tree reaches back 25 generations to 1984. 1 of the 542 devices in its family, counting itself, has a Class I recall.
- Decided
- May 10, 2024
- Review
- 57 days
- Class
- Class II
- Product code
- OVE
- Recalls
- None
- Predicates
- 9
Its longest line of descent runs back 25 generations to K841189 (1984). 541 ancestors in all, the oldest K792352 (1979). No later device cites it as a predicate yet. 1 of the 542 devices in this family, counting this one, has a Class I recall.
- Root · 25 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 21 generations between
- 3 generations backK201643 ChoiceSpine Tiger Shark Cervical Spacer SystemChoice Spine, LLC · 2020
- 2 generations backK203311 ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC · 2021
- 1 generation backK223869 ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC · 2023
- This deviceK240699 SCARLET® AC-TiSpineart SA · 2024
Show all 25 generations
- Root · 25 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 24 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 23 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 22 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 21 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 20 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 19 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 18 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 17 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 16 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 15 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 14 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 13 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 12 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 11 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 10 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 9 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 8 generations backK153782 NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 7 generations backK160916 CoRoent® Ti-C SystemNu Vasive, Incorporated · 2016
- 6 generations backK162138 NuVasive CoRoent Small Ti-C SystemNu Vasive, Incorporated · 2016
- 5 generations backK172676 NuVasive® Modulus-C Interbody SystemNu Vasive, Incorporated · 2017
- 4 generations backK183397 ChoiceSpine Stealth Cervical Spacer SystemChoicespine, LP · 2019
- 3 generations backK201643 ChoiceSpine Tiger Shark Cervical Spacer SystemChoice Spine, LLC · 2020
- 2 generations backK203311 ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC · 2021
- 1 generation backK223869 ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC · 2023
- This deviceK240699 SCARLET® AC-TiSpineart SA · 2024
Class I recalls in this family
- K073202 Ardis Spacer4 generations back · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −25 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −24 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −23 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −22 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −21 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −20 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −19 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −18 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −17 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −16 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −15 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −14 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −13 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −12 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −11 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −10 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −9 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −8 | K153782 | NuVasive® Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −7 | K160916 | CoRoent® Ti-C System | Nu Vasive, Incorporated | 2016 | — |
| −6 | K162138 | NuVasive CoRoent Small Ti-C System | Nu Vasive, Incorporated | 2016 | — |
| −5 | K172676 | NuVasive® Modulus-C Interbody System | Nu Vasive, Incorporated | 2017 | — |
| −4 | K183397 | ChoiceSpine Stealth Cervical Spacer System | Choicespine, LP | 2019 | — |
| −3 | K201643 | ChoiceSpine Tiger Shark Cervical Spacer System | Choice Spine, LLC | 2020 | — |
| −2 | K203311 | ChoiceSpine Blackhawk Ti Cervical Spacer System | Choice Spine, LLC | 2021 | — |
| −1 | K223869 | ChoiceSpine Blackhawk Ti Cervical Spacer System | Choice Spine, LLC | 2023 | — |
| 0 (this device) | K240699 | SCARLET® AC-Ti | Spineart SA | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1993 | 1 | 0 |
| 1996 | 3 | 0 |
| 1998 | 2 | 0 |
| 1999 | 4 | 0 |
| 2000 | 4 | 0 |
| 2001 | 11 | 0 |
| 2002 | 13 | 0 |
| 2003 | 20 | 0 |
| 2004 | 41 | 0 |
| 2005 | 31 | 0 |
| 2006 | 20 | 0 |
| 2007 | 23 | 0 |
| 2008 | 53 | 1 |
| 2009 | 44 | 0 |
| 2010 | 30 | 0 |
| 2011 | 46 | 0 |
| 2012 | 33 | 0 |
| 2013 | 31 | 0 |
| 2014 | 35 | 0 |
| 2015 | 29 | 0 |
| 2016 | 20 | 0 |
| 2017 | 11 | 0 |
| 2018 | 3 | 0 |
| 2019 | 3 | 0 |
| 2020 | 2 | 0 |
| 2023 | 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 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? (9)
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 |
|---|---|---|---|
| * | K141314 | Scarlet AC-T Secured Anterior Cervical Cage and Associated InstrumentationSummary page 4…Orthopedic Primary predicate: SCARLET® AC-T Secured Anterior Cervical Cage manufactured by Spineart (K141314, K143214, K172065, K190322) Additional predicates: Legally marketed… | 2014 |
| * | K143214 | SCARLET® AC-T Secured Anterior Cervical CageSummary page 4…edic Primary predicate: SCARLET® AC-T Secured Anterior Cervical Cage manufactured by Spineart (K141314, K143214, K172065, K190322) Additional predicates: Legally marketed - T… | 2015 |
| * | K172065 | Scarlet AC-TSummary page 4…Primary predicate: SCARLET® AC-T Secured Anterior Cervical Cage manufactured by Spineart (K141314, K143214, K172065, K190322) Additional predicates: Legally marketed - TRYPTIK® T… | 2017 |
| * | K190322 | SCARLET® AC-T Secured Anterior Cervical CageSummary page 4…Primary predicate: SCARLET® AC-T Secured Anterior Cervical Cage manufactured by Spineart (K141314, K143214, K172065, K190322) Additional predicates: Legally marketed - TRYPTIK® Ti manufac… | 2019 |
| * | K200312 | Tryptik TiSummary page 4…214, K172065, K190322) Additional predicates: Legally marketed - TRYPTIK® Ti manufactured by Spineart (K200312, K230583) predicate devices - ChoiceSpine Blackhawk Ti Cervical Spacer System manufactured by… | 2020 |
| * | K230583 | Tryptik TiSummary page 4…065, K190322) Additional predicates: Legally marketed - TRYPTIK® Ti manufactured by Spineart (K200312, K230583) predicate devices - ChoiceSpine Blackhawk Ti Cervical Spacer System manufactured by… | 2023 |
| * | K203311 | ChoiceSpine Blackhawk Ti Cervical Spacer SystemSummary page 4…t (K200312, K230583) predicate devices - ChoiceSpine Blackhawk Ti Cervical Spacer System manufactured by ChoiceSpine LLC (K203311, K223869) - Atlas Spine Expandable Cervical Standalone Interbody System… | 2021 |
| * | K223869 | ChoiceSpine Blackhawk Ti Cervical Spacer SystemSummary page 4…2, K230583) predicate devices - ChoiceSpine Blackhawk Ti Cervical Spacer System manufactured by ChoiceSpine LLC (K203311, K223869) - Atlas Spine Expandable Cervical Standalone Interbody System… | 2023 |
| * | K192570 | Atlas Spine Expandable Cervical Standalone Interbody SystemSummary page 4…23869) - Atlas Spine Expandable Cervical Standalone Interbody System manufactured by Atlas Spine, Inc. (K192570) 510(k) Premarket Notification: SCARLET® AC-Ti - Traditional 510k - P a g e… | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
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 · 4 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 40 years and passes through 15 companies; a new generation was cleared every 11 months on median.
- 57 of the 541 ancestors have a recall of any class; 1 has a Class I recall.
- 5 other devices also cite its predicate K141314.
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. 2024, 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?
SCARLET® AC-Ti cages are indicated for use in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage. SCARLET® AC-Ti cages are intended to be used at one or two contiguous levels from C2-T1 to…
Read the full statement (188 words)
SCARLET® AC-Ti cages are indicated for use in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage. SCARLET® AC-Ti cages are intended to be used at one or two contiguous levels from C2-T1 to facilitate intervertebral body fusion with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. When used with two bone screws, the SCARLET® AC-Ti Secured Anterior Cervical Cage is intended to be used as a standalone system and requires no additional supplementary fixation systems.
When used with two anchors or without two bone screws, the SCARLET® AC-Ti cages are to be used with supplemental fixation which has been cleared by the FDA for use in the cervical spine.
The SCARLET® AC-Ti hyperlordotic (12° lordosis) cages are to be used with bone screws and/or anchors and additional supplemental fixation system that has been cleared by the FDA for use in the cervical spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240699 · printed Nov 4, 2026
Cite this page
510(k) Report. “K240699: SCARLET® AC-Ti.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K240699
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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