510(k) · Cleared
ClearedMONET™ 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 25, 2018 as substantially equivalent to K121569 (Accel Spine, 2012) and 1 other predicate after a 283-day review. Its family tree reaches back 13 generations to 1984. 1 later device descends from it.
- Decided
- Jun 25, 2018
- Review
- 283 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 13 generations to K841189 (1984). 48 ancestors in all. 1 later device descends 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 backK120840 Lexus Cervical Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd. · 2012
- 1 generation backK121569 Matisse Anterior Cervical Interbody Fusion Cage SystemAccel Spine · 2012
- This deviceK172788 MONET™ Anterior Cervical Interbody Fusion Cage SystemCtl Medical Corporation · 2018
- Descendant · cites it directly · 0 of its ownK220513 NITRO Interbody Fusion Cage System FamilyCtl Medical Corporation · 2023
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 backK120840 Lexus Cervical Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd. · 2012
- 1 generation backK121569 Matisse Anterior Cervical Interbody Fusion Cage SystemAccel Spine · 2012
- This deviceK172788 MONET™ Anterior Cervical Interbody Fusion Cage SystemCtl Medical Corporation · 2018
Most influential descendants
Showing 1 of 1 · See all- K220513NITRO Interbody Fusion Cage System FamilyCtl Medical Corporation · 2023 · cites it directly0descendants
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 | K120840 | Lexus Cervical Intervertebral Body Fusion Cage System | L&K BIOMED Co., Ltd. | 2012 | — |
| −1 | K121569 | Matisse Anterior Cervical Interbody Fusion Cage System | Accel Spine | 2012 | — |
| 0 (this device) | K172788 | MONET™ Anterior Cervical Interbody Fusion Cage System | Ctl Medical Corporation | 2018 | — |
| +1 | K220513 | NITRO Interbody Fusion Cage System Family | Ctl Medical Corporation | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 9 | 0 |
| 2002 | 5 | 0 |
| 2003 | 2 | 0 |
| 2004 | 7 | 0 |
| 2005 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K121569 | Matisse Anterior Cervical Interbody Fusion Cage SystemSummary page 4…ual Name: Intervertebral Body Fusion Device Classification Name: Sec 888.3080-Intervertebral Body Fusion Device Product Code: ODP Predicate Device: Primary Predicate: K121569, MATISSE™ Anterior Cervical Interbody Fusion Cage System Additional Predicate: K162682, MATISSE™ Anterior Cervical Interbody Fus… | 2012 |
| * | K162682 | MATISSE Anterior Cervical Interbody Fusion Cage SystemSummary page 4…ebral Body Fusion Device Product Code: ODP Predicate Device: Primary Predicate: K121569, MATISSE™ Anterior Cervical Interbody Fusion Cage System Additional Predicate: K162682, MATISSE™ Anterior Cervical Interbody Fusion Cage System Indications for Use: MONET™ Anterior Cervical Interbody Fusion Cage sy… | 2017 |
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 |
|---|---|---|---|
| K220513 | NITRO Interbody Fusion Cage System Family | 2023 | 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 34 years and passes through 10 companies; a new generation was cleared every 1.3 years on median.
- 4 of the 48 ancestors have a recall of any class.
- Of its descendants, K220513 (Ctl Medical Corporation, 2023) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K121569.
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. 2018, 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?
MONET™ 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. MONET™ Anterior Cervical Interbody Fusion Cage system is used to facilitate intervertebral body fusion in the cervical…
Read the full statement (120 words)
MONET™ 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. MONET™ Anterior Cervical Interbody Fusion Cage system is used to facilitate intervertebral body fusion in the cervical spine at the C2 to C7 disc levels using autograft bone. MONET™ 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/K172788 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172788: MONET™ 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/K172788
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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