510(k) · Cleared
ClearedMATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™
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 Jan 9, 2018 as substantially equivalent to K121569 (Accel Spine, 2012) and 1 other predicate after a 169-day review. Its family tree reaches back 13 generations to 1984. 1 later device descends from it.
- Decided
- Jan 9, 2018
- Review
- 169 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 deviceK172212 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
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 deviceK172212 MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™Ctl 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) | 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 | — |
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 5…Page 2 of 3 Class Class II Classification Number 21 CFR 888.3080 Predicate Devices Primary Predicate: K121569, MATISSE Anterior Cervical Interbody Fusion Cage System; and Additional Predicate: K162682 MATISSE Anterior Cervical Interbody F… | 2012 |
| * | K162682 | MATISSE Anterior Cervical Interbody Fusion Cage SystemSummary page 5…lassification Number 21 CFR 888.3080 Predicate Devices Primary Predicate: K121569, MATISSE Anterior Cervical Interbody Fusion Cage System; and Additional Predicate: K162682 MATISSE Anterior Cervical Interbody Fusion Cage System. Device Description Indications for Use: MATISSE Anterior Cervical Int… | 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?
MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™ 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, Ti-PEEK™ is used to facilitate intervertebral body…
Read the full statement (123 words)
MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™ 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, Ti-PEEK™ 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, Ti-PEEK™ 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 as stated in the FDA summary.
https://510kreport.com/device/K172212 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172212: MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172212
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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