510(k) · Cleared
ClearedSCARLET® AC-T Secured Anterior Cervical Cage
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spineart · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on Mar 4, 2019 as substantially equivalent to K172065 (Spineart, 2017) and 2 other predicates after a 19-day review. Its family tree reaches back 17 generations to 1984. 1 later device descends from it.
- Decided
- Mar 4, 2019
- Review
- 19 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 17 generations to K841189 (1984). 134 ancestors in all, the oldest K792352 (1979). 1 later device descends from it, 1 citing it directly.
- Root · 17 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 13 generations between
- 3 generations backK141314 Scarlet AC-T Secured Anterior Cervical Cage and Associated…Spineart · 2014
- 2 generations backK143214 SCARLET® AC-T Secured Anterior Cervical CageSpineart · 2015
- 1 generation backK172065 Scarlet AC-TSpineart · 2017
- This deviceK190322 SCARLET® AC-T Secured Anterior Cervical CageSpineart · 2019
- Descendant · cites it directly · 0 of its ownK240699 SCARLET® AC-TiSpineart SA · 2024
Show all 17 generations
- Root · 17 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 16 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 15 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 14 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 13 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 12 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 11 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 10 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 9 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 8 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
- 7 generations backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- 6 generations backK083475 Lucent MagnumSpinal Elements, Inc. · 2009
- 5 generations backK092211 Chesapeake Spinal SystemK2m, Inc. · 2010
- 4 generations backK111439 Chesapeake (Cervical Components)K2m, Inc. · 2011 · Recalled
- 3 generations backK141314 Scarlet AC-T Secured Anterior Cervical Cage and Associated…Spineart · 2014
- 2 generations backK143214 SCARLET® AC-T Secured Anterior Cervical CageSpineart · 2015
- 1 generation backK172065 Scarlet AC-TSpineart · 2017
- This deviceK190322 SCARLET® AC-T Secured Anterior Cervical CageSpineart · 2019
Most influential descendants
Showing 1 of 1 · See all- K240699SCARLET® AC-TiSpineart SA · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −16 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −15 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −14 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −13 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −12 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −11 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −10 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −9 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −8 | K080083 | Intrepid Spinal System | Medtronic Sofamor Danek | 2008 | 8 |
| −7 | K073109 | Stalif TT Intervertebral Body Fusion System | Surgicraft, Ltd. | 2008 | — |
| −6 | K083475 | Lucent Magnum | Spinal Elements, Inc. | 2009 | — |
| −5 | K092211 | Chesapeake Spinal System | K2m, Inc. | 2010 | — |
| −4 | K111439 | Chesapeake (Cervical Components) | K2m, Inc. | 2011 | 1 |
| −3 | K141314 | Scarlet AC-T Secured Anterior Cervical Cage and Associated Instrumentation | Spineart | 2014 | — |
| −2 | K143214 | SCARLET® AC-T Secured Anterior Cervical Cage | Spineart | 2015 | — |
| −1 | K172065 | Scarlet AC-T | Spineart | 2017 | — |
| 0 (this device) | K190322 | SCARLET® AC-T Secured Anterior Cervical Cage | Spineart | 2019 | — |
| +1 | 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 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 10 | 0 |
| 2002 | 8 | 0 |
| 2003 | 11 | 0 |
| 2004 | 18 | 0 |
| 2005 | 7 | 0 |
| 2006 | 6 | 0 |
| 2007 | 8 | 0 |
| 2008 | 17 | 0 |
| 2009 | 8 | 0 |
| 2010 | 5 | 0 |
| 2011 | 6 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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.
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 |
|---|---|---|---|
| * | K172065 | Scarlet AC-TSummary page 4…ODP / OVE CFR section 888.3080 Device panel ORTHOPEDIC Primary predicate: SCARLET® AC-T Secured Anterior Cervical Cage (K172065) Legally marketed manufactured by SPINEART predicate devices Additional predicates: SCARLET® AC-T Secured Anterior C… | 2017 |
| * | K143214 | SCARLET® AC-T Secured Anterior Cervical CageSummary page 4…ior Cervical Cage (K172065) Legally marketed manufactured by SPINEART predicate devices Additional predicates: SCARLET® AC-T Secured Anterior Cervical Cage (K143214 and K141314) manufactured by SPINEART… | 2015 |
| * | K141314 | Scarlet AC-T Secured Anterior Cervical Cage and Associated InstrumentationSummary page 4…marketed manufactured by SPINEART predicate devices Additional predicates: SCARLET® AC-T Secured Anterior Cervical Cage (K143214 and K141314) manufactured by SPINEART… | 2014 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K240699 | SCARLET® AC-Ti | 2024 | 0 |
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 35 years and passes through 12 companies; a new generation was cleared every 1.1 years on median.
- 14 of the 134 ancestors have a recall of any class.
- Of its descendants, K240699 (Spineart SA, 2024) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K172065.
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. 2019, 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?
SCARLET® AC-T 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-T cages are intended to be used at one level from the C2-C3 disc to the C7-T1…
Read the full statement (154 words)
SCARLET® AC-T 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-T cages are intended to be used at one level from the C2-C3 disc to the C7-T1 disc to facilitate intervertebral body fusion with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.
The SCARLET® AC-T Secured Anterior Cervical Cage is intended to be used as a standalone system used with the two bone screws provided and requires no additional supplementary fixation systems. When used without the two bone screws, SCARLET AC-T cages are to be used with supplemental fixation which 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/K190322 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190322: SCARLET® AC-T Secured Anterior Cervical Cage.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190322
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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