510(k) · Cleared
Clearednvc
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 Mar 21, 2019 as substantially equivalent to K170074 (Nvision Biomedical Technologies, LLC, 2017) and 1 other predicate after a 30-day review. Its family tree reaches back 12 generations to 1984. 3 later devices descend from it.
- Decided
- Mar 21, 2019
- Review
- 30 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 12 generations to K841189 (1984). 39 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 12 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 8 generations between
- 3 generations backK091088 LDR Spine Cervical Interbody Fusion SystemLdr Spine USA · 2009
- 2 generations backK103034 Genesys Spine Interbody Fusion SystemGenesys Spine · 2010 · Recalled
- 1 generation backK142328 nvcNvision Biomedical Technologies, LLC · 2014
- This deviceK190380 nvcNvision Biomedical Technologies, Inc. · 2019
- Descendant · cites it directly · 1 of its ownK222015 Integral Titanium Cervical InterbodyNvision Biomedical Technologies, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK243673 Xenco Medical CancelleX Cervical Interbody SystemXenco Medical, LLC · 2025
- Descendant · cites it directly · 0 of its ownK240250 3D Printed PEEK Interbody SystemNvision Biomedical Technologies, Inc. · 2024
Show all 12 generations
- Root · 12 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 11 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 10 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 9 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 8 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 7 generations backK033109 Ellys and Aurys Vertebral Body ReplacementsScient'X · 2004
- 6 generations backK043479 MC+ Partial VBRLdr Spine USA · 2005
- 5 generations backK080728 LDR Spine Roi-C ImplantLdr Spine USA · 2008
- 4 generations backK083857 LDR Spine Roi-C ImplantLdr Spine USA · 2009
- 3 generations backK091088 LDR Spine Cervical Interbody Fusion SystemLdr Spine USA · 2009
- 2 generations backK103034 Genesys Spine Interbody Fusion SystemGenesys Spine · 2010 · Recalled
- 1 generation backK142328 nvcNvision Biomedical Technologies, LLC · 2014
- This deviceK190380 nvcNvision Biomedical Technologies, Inc. · 2019
Most influential descendants
Showing 3 of 3 · See all- K222015Integral Titanium Cervical InterbodyNvision Biomedical Technologies, Inc. · 2023 · cites it directly1descendant
- K243673Xenco Medical CancelleX Cervical Interbody SystemXenco Medical, LLC · 2025 · 2 generations on0descendants
- K2402503D Printed PEEK Interbody SystemNvision Biomedical Technologies, Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −11 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −10 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −9 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −8 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −7 | K033109 | Ellys and Aurys Vertebral Body Replacements | Scient'X | 2004 | — |
| −6 | K043479 | MC+ Partial VBR | Ldr Spine USA | 2005 | — |
| −5 | K080728 | LDR Spine Roi-C Implant | Ldr Spine USA | 2008 | — |
| −4 | K083857 | LDR Spine Roi-C Implant | Ldr Spine USA | 2009 | — |
| −3 | K091088 | LDR Spine Cervical Interbody Fusion System | Ldr Spine USA | 2009 | — |
| −2 | K103034 | Genesys Spine Interbody Fusion System | Genesys Spine | 2010 | 1 |
| −1 | K142328 | nvc | Nvision Biomedical Technologies, LLC | 2014 | — |
| 0 (this device) | K190380 | nvc | Nvision Biomedical Technologies, Inc. | 2019 | — |
| +1 | K222015 | Integral Titanium Cervical Interbody | Nvision Biomedical Technologies, Inc. | 2023 | — |
| +2 | K243673 | Xenco Medical CancelleX Cervical Interbody System | Xenco Medical, LLC | 2025 | — |
| +1 | K240250 | 3D Printed PEEK Interbody System | Nvision Biomedical Technologies, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 8 | 0 |
| 2002 | 4 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 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.
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 |
|---|---|---|---|
| * | K170074 | nvcSummary page 5…Predicate Device Name / Manufacturer Primary Predicate K170074 nvc from Nvision Biomedical Technologies K142328 nvc from Nvision Biomedical Te… | 2017 |
| * | K142328 | nvcSummary page 5…Predicate K170074 nvc from Nvision Biomedical Technologies K142328 nvc from Nvision Biomedical Technologies SUMMARY OF NON-CLINICAL TESTING No FDA performance standards have been establis… | 2014 |
What descends from it? (3)
2 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?
- The line of descent spans 35 years and passes through 9 companies; a new generation was cleared every 1.7 years on median.
- 7 of the 39 ancestors have a recall of any class.
- Of its descendants, K222015 (Nvision Biomedical Technologies, Inc., 2023) 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. 2019, 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 nvc 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 neck 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 nvc 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 as stated in the FDA summary.
https://510kreport.com/device/K190380 · printed Nov 5, 2026
Cite this page
510(k) Report. “K190380: nvc.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K190380
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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