510(k) · Cleared
ClearedMATISSE Anterior Cervical Interbody Fusion Cage System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ctl Medical Corporation · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on Jun 1, 2017 after a 248-day review. The FDA summary names its predicate without a number. 4 later devices descend from it.
- Decided
- Jun 1, 2017
- Review
- 248 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 4 citing it directly.
- This deviceK162682 MATISSE Anterior Cervical Interbody Fusion Cage SystemCtl Medical Corporation · 2017
- Descendant · cites it directly · 1 of its ownK172788 MONET™ Anterior Cervical Interbody Fusion Cage SystemCtl Medical Corporation · 2018
- Descendant · cites it directly · 1 of its ownK172212 MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™Ctl Medical Corporation · 2018
- Descendant · cites it directly · 0 of its ownK220513 NITRO Interbody Fusion Cage System FamilyCtl Medical Corporation · 2023
- Descendant · cites it directly · 0 of its ownK192044 4CIS Marlin PEEK ACIF CageSolco Biomedical Co., Ltd. · 2019
Most influential descendants
Showing 4 of 4 · See all- K172788MONET™ Anterior Cervical Interbody Fusion Cage SystemCtl Medical Corporation · 2018 · cites it directly1descendant
- K172212MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™Ctl Medical Corporation · 2018 · cites it directly1descendant
- K220513NITRO Interbody Fusion Cage System FamilyCtl Medical Corporation · 2023 · cites it directly0descendants
- K1920444CIS Marlin PEEK ACIF CageSolco Biomedical Co., Ltd. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K162682 | MATISSE Anterior Cervical Interbody Fusion Cage System | Ctl Medical Corporation | 2017 | — |
| +1 | K172788 | MONET™ Anterior Cervical Interbody Fusion Cage System | Ctl Medical Corporation | 2018 | — |
| +1 | K172212 | MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™ | Ctl Medical Corporation | 2018 | — |
| +1 | K220513 | NITRO Interbody Fusion Cage System Family | Ctl Medical Corporation | 2023 | — |
| +1 | K192044 | 4CIS Marlin PEEK ACIF Cage | Solco Biomedical Co., Ltd. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 2 | 0 |
| 2019 | 1 | 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.
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? (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 |
|---|---|---|---|
| * | — | MATISSE Anterior Cervical Interbody Fusion Cage System Named without a submission number |
What descends from it? (4)
4 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?
- Of its descendants, K172788 (Ctl Medical Corporation, 2018) has gone furthest, with 1 descendant of its own.
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. 2017, 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?
MATISSE Anterior Cervical Interbody Fusion Cage system is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one-disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. MATISSE Anterior Cervical Interbody Fusion Cage system is used to facilitate intervertebral body fusion in the…
Read the full statement (120 words)
MATISSE Anterior Cervical Interbody Fusion Cage system is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one-disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. MATISSE Anterior Cervical Interbody Fusion Cage system is used to facilitate intervertebral body fusion in the cervical spine at the C3 to C7 disc levels using autograft bone. MATISSE Anterior Cervical Interbody Fusion Cage system is to be used with supplemental fixation systems that have been cleared for use in the cervical spine. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.
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/K162682 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162682: MATISSE Anterior Cervical Interbody Fusion Cage System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162682
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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