510(k) · Cleared
Clearednva, nvp, and nvt
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nvision Biomedical Technologies, LLC · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Sep 29, 2016 after a 30-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 4 later devices descend from it.
- Decided
- Sep 29, 2016
- Review
- 30 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 1
4 later devices descend from it, 1 citing it directly.
- This deviceK162426 nva, nvp, and nvtNvision Biomedical Technologies, LLC · 2016
- Descendant · cites it directly · 3 of its ownK193645 nva, nvp, and nvtNvision Biomedical Technologies, Inc. · 2020
- Descendant · 2 generations on · 1 of its ownK212477 EARP Interbody SystemNvision Biomedical Technologies, Inc. · 2022
- Descendant · 2 generations on · 0 of its ownK242457 EARP Interbody SystemRetropsoas Technologies, LLC · 2024
- Descendant · 2 generations on · 0 of its ownK240250 3D Printed PEEK Interbody SystemNvision Biomedical Technologies, Inc. · 2024
Most influential descendants
Showing 4 of 4 · See all- K193645nva, nvp, and nvtNvision Biomedical Technologies, Inc. · 2020 · cites it directly3descendants
- K212477EARP Interbody SystemNvision Biomedical Technologies, Inc. · 2022 · 2 generations on1descendant
- K242457EARP Interbody SystemRetropsoas Technologies, LLC · 2024 · 2 generations on0descendants
- K2402503D Printed PEEK Interbody SystemNvision Biomedical Technologies, Inc. · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K162426 | nva, nvp, and nvt | Nvision Biomedical Technologies, LLC | 2016 | — |
| +1 | K193645 | nva, nvp, and nvt | Nvision Biomedical Technologies, Inc. | 2020 | — |
| +2 | K212477 | EARP Interbody System | Nvision Biomedical Technologies, Inc. | 2022 | — |
| +2 | K242457 | EARP Interbody System | Retropsoas Technologies, LLC | 2024 | — |
| +2 | K240250 | 3D Printed PEEK Interbody System | Nvision Biomedical Technologies, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 2 | 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 MAX? 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 MAX device
- #1 K203714 NuVasive Thoracolumbar Interbody Systems…score 102.5 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K142594 | FDA’s K142594 is nva, nvp, nvt Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2014 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K193645 | nva, nvp, and nvt | 2020 | 3 |
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?
- Of its descendants, K193645 (Nvision Biomedical Technologies, Inc., 2020) has gone furthest, with 3 descendants of its own.
How does its category compare?
All MAX devicesMAX Intervertebral Fusion Device With Bone Graft, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · MAX
29in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MAX
85in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MAX
5in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · MAX
811in 2025
MAUDE reports naming product code MAX, 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 | 7 | 86 | 0 | 12 |
| 2008 | 35 | 88 | 2 | 19 |
| 2009 | 31 | 102 | 9 | 90 |
| 2010 | 29 | 137 | 0 | 154 |
| 2011 | 49 | 98 | 3 | 201 |
| 2012 | 48 | 69 | 11 (1) | 327 |
| 2013 | 58 | 102 | 0 | 380 |
| 2014 | 58 | 115 | 3 | 366 |
| 2015 | 53 | 113 | 1 | 524 |
| 2016 | 64 | 124 | 6 | 647 |
| 2017 | 76 | 116 | 1 | 596 |
| 2018 | 64 | 114 | 4 | 616 |
| 2019 | 60 | 131 | 1 | 699 |
| 2020 | 56 | 106 | 0 | 640 |
| 2021 | 53 | 109 | 0 | 622 |
| 2022 | 41 | 95 | 1 | 618 |
| 2023 | 30 | 87 | 0 | 576 |
| 2024 | 38 | 91 | 1 | 729 |
| 2025 | 29 | 85 | 5 | 811 |
| 2026 | 18 | 95 | 0 | — |
What is it indicated for?
The nva, nvp, and nvt are intended for intervertebral body fusion in the lumbar spine in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 of the lumbosacral spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment prior to treatment with an…
Read the full statement (112 words)
The nva, nvp, and nvt are intended for intervertebral body fusion in the lumbar spine in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 of the lumbosacral spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment prior to treatment with an intervertebral cage. DDD patients may also have Grade 1 spondylolisthesis or retrolisthesis at involved levels. The device systems must be used with supplemental fixation and autograft to facilitate fusion and are implanted via an anterior, posterior, or transforaminal approach.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162426 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162426: nva, nvp, and nvt.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162426
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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