510(k) · Cleared
ClearedNITRO Interbody Fusion Cage System Family
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 Apr 25, 2023 as substantially equivalent to K143518 (Amedica Corp., 2015) and 7 other predicates after a 427-day review. Its family tree reaches back 22 generations to 1984.
- Decided
- Apr 25, 2023
- Review
- 427 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 22 generations to K841189 (1984). 256 ancestors in all. No later device cites it as a predicate yet.
- Root · 22 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 18 generations between
- 3 generations backK170962 NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated · 2017
- 2 generations backK171633 NuVasive TLX Interbody SystemNu Vasive, Incorporated · 2017
- 1 generation backK192863 MONDRIAN Lumbar Interbody Fusion Cage SystemCtl Medical Corporation · 2020
- This deviceK220513 NITRO Interbody Fusion Cage System FamilyCtl Medical Corporation · 2023
Show all 22 generations
- Root · 22 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 21 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 20 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 19 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 18 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 17 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 16 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 15 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 14 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 13 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 12 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 11 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 10 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 9 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 8 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 7 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 6 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 5 generations backK153782 NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 4 generations backK161230 NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 3 generations backK170962 NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated · 2017
- 2 generations backK171633 NuVasive TLX Interbody SystemNu Vasive, Incorporated · 2017
- 1 generation backK192863 MONDRIAN Lumbar Interbody Fusion Cage SystemCtl Medical Corporation · 2020
- This deviceK220513 NITRO Interbody Fusion Cage System FamilyCtl Medical Corporation · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −22 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −21 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −20 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −19 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −18 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −17 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −16 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −15 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −14 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −13 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −12 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −11 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −10 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −9 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −8 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −7 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −6 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −5 | K153782 | NuVasive® Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −4 | K161230 | NuVasive Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −3 | K170962 | NuVasive® CoRoent® Thoracolumbar System | Nu Vasive, Incorporated | 2017 | — |
| −2 | K171633 | NuVasive TLX Interbody System | Nu Vasive, Incorporated | 2017 | — |
| −1 | K192863 | MONDRIAN Lumbar Interbody Fusion Cage System | Ctl Medical Corporation | 2020 | — |
| 0 (this device) | 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 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 10 | 0 |
| 2002 | 9 | 0 |
| 2003 | 14 | 0 |
| 2004 | 21 | 0 |
| 2005 | 15 | 0 |
| 2006 | 8 | 0 |
| 2007 | 12 | 0 |
| 2008 | 36 | 0 |
| 2009 | 22 | 0 |
| 2010 | 15 | 0 |
| 2011 | 18 | 0 |
| 2012 | 13 | 0 |
| 2013 | 11 | 0 |
| 2014 | 10 | 0 |
| 2015 | 6 | 0 |
| 2016 | 4 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 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? (8)
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 |
|---|---|---|---|
| * | K143518 | Valeo Spacer System and Valeo II Interbody Fusion Device SystemSummary page 6…Page 2 of 4 III. PREDICATE DEVICES Primary Predicate: x VALEO Spacer System; VALEO II Interbody Fusion Device System (K143518), (K161405) (primary predicate) Additional Predicates: x MATISSE Anterior Cervical Interbody Cag… | 2015 |
| * | K161405 | Valeo II Interbody Fusion Device SystemSummary page 6…Page 2 of 4 III. PREDICATE DEVICES Primary Predicate: x VALEO Spacer System; VALEO II Interbody Fusion Device System (K143518), (K161405) (primary predicate) Additional Predicates: x MATISSE Anterior Cervical Interbody Cage System (K121569, K16268… | 2016 |
| * | K121569 | Matisse Anterior Cervical Interbody Fusion Cage SystemSummary page 6…Fusion Device System (K143518), (K161405) (primary predicate) Additional Predicates: x MATISSE Anterior Cervical Interbody Cage System (K121569, K162682, K172212) x MONET Anterior Cervical Interbody Fusion Cage System (K172788) x MONET Anterior Cerv… | 2012 |
| * | K162682 | MATISSE Anterior Cervical Interbody Fusion Cage SystemSummary page 6…evice System (K143518), (K161405) (primary predicate) Additional Predicates: x MATISSE Anterior Cervical Interbody Cage System (K121569, K162682, K172212) x MONET Anterior Cervical Interbody Fusion Cage System (K172788) x MONET Anterior Cervical Inte… | 2017 |
| * | K172212 | MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™Summary page 6…tem (K143518), (K161405) (primary predicate) Additional Predicates: x MATISSE Anterior Cervical Interbody Cage System (K121569, K162682, K172212) x MONET Anterior Cervical Interbody Fusion Cage System (K172788) x MONET Anterior Cervical Interbody Fus… | 2018 |
| * | K172788 | MONET™ Anterior Cervical Interbody Fusion Cage SystemSummary page 6…Predicates: x MATISSE Anterior Cervical Interbody Cage System (K121569, K162682, K172212) x MONET Anterior Cervical Interbody Fusion Cage System (K172788) x MONET Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate (K182151), an… | 2018 |
| * | K182151 | MONET Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation PlateSummary page 6…erior Cervical Interbody Fusion Cage System (K172788) x MONET Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate (K182151), and x MONDRIAN Lumbar Interbody Fusion Cage System (K192863) IV. DEVICE DESCRIPTION The NITRO Interbody… | 2018 |
| * | K192863 | MONDRIAN Lumbar Interbody Fusion Cage SystemSummary page 6…Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate (K182151), and x MONDRIAN Lumbar Interbody Fusion Cage System (K192863) IV. DEVICE DESCRIPTION The NITRO Interbody Fusion Cage System Family (Cervical and Lumbar ) cages offer a com… | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
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 39 years and passes through 13 companies; a new generation was cleared every 11 months on median.
- 26 of the 256 ancestors have a recall of any class.
- 2 other devices also cite its predicate K143518.
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. 2023, 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?
“CERVICAL” NITRO Interbody Fusion Cage System Family (i.e., the MATISSE NITRO Anterior Cervical Interbody Fusion Cage System and the MONET NITRO Anterior Cervical Interbody Fusion Cage System) are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level or two contiguous levels. DDD is defined as discogenic pain with degeneration of the disc confirmed…
Read the full statement (350 words)
“CERVICAL” NITRO Interbody Fusion Cage System Family (i.e., the MATISSE NITRO Anterior Cervical Interbody Fusion Cage System and the MONET NITRO Anterior Cervical Interbody Fusion Cage System) are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level or two contiguous levels.
DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Cervical NITRO Interbody Fusion Cage System Family are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach from the C2-C3 disc space to C7-T1 disc space using autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.
Cervical NITRO Interbody Fusion Cage System Family are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.
When the MONET Anterior Cervical Interbody Fusion Cage System is used with the Supplementary Fixation Plate assembly, the plate-spacer assembly is a stand-alone device intended for use at one disc level or two contiguous levels of the cervical spine (from the C2-C3 disc space to C7-T1 disc space).
“LUMBAR” NITRO Interbody Fusion Cage System Family (i.e.; the MONDRIAN NITRO Lumbar Interbody Fusion Cage System consisting of ALIF/OLIF, DLIF, PLIF, and TLIF) are indicated for use with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or cortico-cancellous bone graft in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.
DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s).
Lumbar NITRO Interbody Fusion Cage System Family are intended to be used with supplemental spinal fixation systems. Patients should be skeletally mature and have six months of non-operative therapy prior to treatment with an intervertebral cage.
Lumbar NITRO Interbody Fusion Cage System Family with hyperlordotic cage offerings (>20°) require the use of anterior fixation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220513 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220513: NITRO Interbody Fusion Cage System Family.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220513
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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