510(k) · Cleared
ClearedDIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) Cage
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dio Medical Co., Ltd. · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on Nov 21, 2016 after a 105-day review. The FDA summary names its predicate without a number. 9 later devices descend from it.
- Decided
- Nov 21, 2016
- Review
- 105 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 4 citing it directly.
- This deviceK162220 DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) CageDio Medical Co., Ltd. · 2016
- Descendant · cites it directly · 2 of its ownK172419 Velofix™ TLIF CageU&I Corporation · 2017
- Descendant · cites it directly · 2 of its ownK173080 IVA Cage Ti (ACIF, PLIF, TLIF, DLIF, and ALIF)Huvexel Co., Ltd. · 2017
- Descendant · cites it directly · 1 of its ownK212038 K&J IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK CageK&J Consulting Corporation · 2021
- Descendant · 2 generations on · 1 of its ownK181829 Velofix TLIF CageU&I Corporation · 2018
- Descendant · 2 generations on · 0 of its ownK250335 IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting · 2025
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K172419Velofix™ TLIF CageU&I Corporation · 2017 · cites it directly2descendants
- K173080IVA Cage Ti (ACIF, PLIF, TLIF, DLIF, and ALIF)Huvexel Co., Ltd. · 2017 · cites it directly2descendants
- K212038K&J IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK CageK&J Consulting Corporation · 2021 · cites it directly1descendant
- K181829Velofix TLIF CageU&I Corporation · 2018 · 2 generations on1descendant
- K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K162220 | DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) Cage | Dio Medical Co., Ltd. | 2016 | — |
| +1 | K172419 | Velofix™ TLIF Cage | U&I Corporation | 2017 | — |
| +1 | K173080 | IVA Cage Ti (ACIF, PLIF, TLIF, DLIF, and ALIF) | Huvexel Co., Ltd. | 2017 | — |
| +1 | K212038 | K&J IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage | K&J Consulting Corporation | 2021 | — |
| +2 | K181829 | Velofix TLIF Cage | U&I Corporation | 2018 | — |
| +2 | K250335 | IVA & AEON Cervical and Lumbar Cage System | K&J Consulting | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2021 | 3 | 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? (5)
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 |
|---|---|---|---|
| * | — | Galaxy PEEK Cage Named without a submission number | |
| * | — | Synster Cage Named without a submission number | |
| * | — | VENTUS Lumbar Intervertebral Body Fusion Cage System Named without a submission number | |
| * | — | Inness PEEK Cage Named without a submission number | |
| * | — | AnyPlus PEEK Cage Named without a submission number |
What descends from it? (9)
4 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?
- Of its descendants, K172419 (U&I Corporation, 2017) has gone furthest, with 2 descendants 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. 2016, 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 DIO Medical IVA (ACIF) Cage is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-T1 disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device is designed for use with supplemental fixation and with autograft to…
Read the full statement (188 words)
The DIO Medical IVA (ACIF) Cage is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-T1 disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device is designed for use with supplemental fixation and with autograft to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.
The DIO Medical IVA (PLIF, TLIF, DLIF and ALIF) Cage is indicated for intervertebral body fusion of the lumbar spine, L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at one or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.
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/K162220 · printed Nov 5, 2026
Cite this page
510(k) Report. “K162220: DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) Cage.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K162220
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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