510(k) · Cleared
ClearedIntegral Titanium Cervical Interbody
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nvision Biomedical Technologies, Inc. · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on Jul 5, 2023 as substantially equivalent to K190380 (Nvision Biomedical Technologies, Inc., 2019) and 2 other predicates after a 362-day review. Its family tree reaches back 24 generations to 1984. 1 of the 283 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Jul 5, 2023
- Review
- 362 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 24 generations to K841189 (1984). 281 ancestors in all, the oldest K792352 (1979). 1 later device descends from it, 1 citing it directly. 1 of the 283 devices in this family, counting this one, has a Class I recall.
- Root · 24 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 20 generations between
- 3 generations backK193359 SureMAX Family of Cervical SpacersAdditive Implants, Inc. · 2020
- 2 generations backK202666 CONSTRUX Mini PTC Spacer SystemOrthofix, Inc. · 2020
- 1 generation backK203342 CONSTRUX Mini Ti Spacer SystemOrthofix, Inc. · 2021 · Recalled
- This deviceK222015 Integral Titanium Cervical InterbodyNvision Biomedical Technologies, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK243673 Xenco Medical CancelleX Cervical Interbody SystemXenco Medical, LLC · 2025
Show all 24 generations
- Root · 24 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 23 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 22 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 21 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 20 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 19 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 18 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 17 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 16 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 15 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 14 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 13 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 12 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 11 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 10 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 9 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 8 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 7 generations backK143616 AccuLIF TL and PL CageStryker Corporation · 2015 · Recalled
- 6 generations backK152304 Tritanium PL CageStryker · 2015 · Recalled
- 5 generations backK160125 Cascadia Interbody SystemK2m · 2016
- 4 generations backK182477 Cervical SpacerAdditive Implants, LLC · 2019
- 3 generations backK193359 SureMAX Family of Cervical SpacersAdditive Implants, Inc. · 2020
- 2 generations backK202666 CONSTRUX Mini PTC Spacer SystemOrthofix, Inc. · 2020
- 1 generation backK203342 CONSTRUX Mini Ti Spacer SystemOrthofix, Inc. · 2021 · Recalled
- This deviceK222015 Integral Titanium Cervical InterbodyNvision Biomedical Technologies, Inc. · 2023
Class I recalls in this family
- K073202 Ardis Spacer5 generations back · 2008
Most influential descendants
Showing 1 of 1 · See all- K243673Xenco Medical CancelleX Cervical Interbody SystemXenco Medical, LLC · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −24 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −23 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −22 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −21 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −20 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −19 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −18 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −17 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −16 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −15 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −14 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −13 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −12 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −11 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −10 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −9 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −8 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −7 | K143616 | AccuLIF TL and PL Cage | Stryker Corporation | 2015 | 4 |
| −6 | K152304 | Tritanium PL Cage | Stryker | 2015 | 1 |
| −5 | K160125 | Cascadia Interbody System | K2m | 2016 | — |
| −4 | K182477 | Cervical Spacer | Additive Implants, LLC | 2019 | — |
| −3 | K193359 | SureMAX Family of Cervical Spacers | Additive Implants, Inc. | 2020 | — |
| −2 | K202666 | CONSTRUX Mini PTC Spacer System | Orthofix, Inc. | 2020 | — |
| −1 | K203342 | CONSTRUX Mini Ti Spacer System | Orthofix, Inc. | 2021 | 1 |
| 0 (this device) | K222015 | Integral Titanium Cervical Interbody | Nvision Biomedical Technologies, Inc. | 2023 | — |
| +1 | K243673 | Xenco Medical CancelleX Cervical Interbody System | Xenco Medical, LLC | 2025 | — |
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 | 15 | 0 |
| 2004 | 25 | 0 |
| 2005 | 17 | 0 |
| 2006 | 10 | 0 |
| 2007 | 12 | 0 |
| 2008 | 40 | 1 |
| 2009 | 26 | 0 |
| 2010 | 18 | 0 |
| 2011 | 20 | 0 |
| 2012 | 11 | 0 |
| 2013 | 6 | 0 |
| 2014 | 16 | 0 |
| 2015 | 5 | 0 |
| 2016 | 3 | 0 |
| 2017 | 4 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K190380 | nvcSummary page 5…ical Interbody is substantially equivalent to the following predicates: 510(k) Number Predicate Device Name / Manufacturer Predicate K190380 Nvision Biomedical Technologies nvc System Primary K171140 Nexxt Spine Matrixx Syst… | 2019 |
| * | K171140 | Matrixx SystemSummary page 5…Predicate Device Name / Manufacturer Predicate K190380 Nvision Biomedical Technologies nvc System Primary K171140 Nexxt Spine Matrixx System Additional K203342 Orthofix CONSTRUX Min… | 2017 |
| * | K203342 | CONSTRUX Mini Ti Spacer SystemSummary page 5…Nvision Biomedical Technologies nvc System Primary K171140 Nexxt Spine Matrixx System Additional K203342 Orthofix CONSTRUX Mini Ti Spacer System Additional The following reference devices are also c… | 2021 |
| † | K210424 | Quantum Anterior Cervical Plate | 2021 |
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 |
|---|---|---|---|
| K243673 | Xenco Medical CancelleX Cervical Interbody System | 2025 | 0 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K073202Ardis SpacerAbbott Spine, Inc. · 2008 · 5 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 39 years and passes through 17 companies; a new generation was cleared every 10 months on median.
- 39 of the 281 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K243673 (Xenco Medical, LLC, 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K190380.
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?
The Integral Titanium Cervical Interbody is intended for spinal fusion procedures at one level, from C2-T1, in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine. DDD is defined as back pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies. One device is to be used per intervertebral space. Patients should receive six weeks of non-operative treatment prior to treatment…
Read the full statement (109 words)
The Integral Titanium Cervical Interbody is intended for spinal fusion procedures at one level, from C2-T1, in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine. DDD is defined as back pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies. One device is to be used per intervertebral space. Patients should receive six weeks of non-operative treatment prior to treatment with an intervertebral body fusion device. The Integral Titanium Cervical Interbody devices must be used with supplemental fixation and are designed for use with autograft bone to facilitate fusion. The devices are to be implanted via an anterior approach.
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/K222015 · printed Nov 6, 2026
Cite this page
510(k) Report. “K222015: Integral Titanium Cervical Interbody.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K222015
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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