510(k) · Cleared
ClearedNeckTune™ SA Cervical Cage
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medyssey Co., Ltd. · OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
Cleared on Sep 29, 2026 as substantially equivalent to K210573 (U&I Corporation, 2021) after a 60-day review. Its family tree reaches back 18 generations to 2001. 1 of the 144 devices in its family, counting itself, has a Class I recall.
- Decided
- Sep 29, 2026
- Review
- 60 days
- Class
- Class II
- Product code
- OVE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 18 generations to K003155 (2001). 143 ancestors in all, the oldest K841189 (1984). No later device cites it as a predicate yet. 1 of the 144 devices in this family, counting this one, has a Class I recall.
- Root · 18 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 14 generations between
- 3 generations backK161280 Cervical Stand Alone SystemOrthofix, Inc. · 2016
- 2 generations backK172424 Velofix™ SA Cervical CageU&I Corporation · 2017 · Recalled
- 1 generation backK210573 Velofix SA Cervical CageU&I Corporation · 2021
- This deviceK262726 NeckTune™ SA Cervical CageMedyssey Co., Ltd. · 2026
Show all 18 generations
- Root · 18 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 17 generations backK012254 VBROsteotech, Inc. · 2001
- 16 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 15 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 14 generations backK031780 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 13 generations backK040731 Stryker Spine Vertebral SpacerStryker Spine · 2004
- 12 generations backK042571 Stryker Spine Avs TL Peek SpacerStryker Spine · 2005
- 11 generations backK050624 Stryker Spine Avs PL Peek SpacerStryker Spine · 2005
- 10 generations backK051205 Stryker Spine Avs Asl Peek SpacerStryker Spine · 2005
- 9 generations backK060762 Aesculap Peek Vertebral Body Replacement SystemAesculap, Inc. · 2006
- 8 generations backK071983 Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace…Aesculap Implant Systems, Inc. · 2008 · Recalled
- 7 generations backK083311 Aesculap Cespace Peek Intervertebral Body Fusion SystemAesculap Implant Systems, Inc. · 2009
- 6 generations backK100889 Endoskeleton TCTitan Spine, LLC · 2010
- 5 generations backK121649 Construx Mini Peek TI Spacer SystemOrthofix · 2012
- 4 generations backK142152 Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand…Orthofix, Inc. · 2015
- 3 generations backK161280 Cervical Stand Alone SystemOrthofix, Inc. · 2016
- 2 generations backK172424 Velofix™ SA Cervical CageU&I Corporation · 2017 · Recalled
- 1 generation backK210573 Velofix SA Cervical CageU&I Corporation · 2021
- This deviceK262726 NeckTune™ SA Cervical CageMedyssey Co., Ltd. · 2026
Class I recalls in this family
- K073202 Ardis Spacer5 generations back · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −17 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −16 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −15 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −14 | K031780 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −13 | K040731 | Stryker Spine Vertebral Spacer | Stryker Spine | 2004 | — |
| −12 | K042571 | Stryker Spine Avs TL Peek Spacer | Stryker Spine | 2005 | — |
| −11 | K050624 | Stryker Spine Avs PL Peek Spacer | Stryker Spine | 2005 | — |
| −10 | K051205 | Stryker Spine Avs Asl Peek Spacer | Stryker Spine | 2005 | — |
| −9 | K060762 | Aesculap Peek Vertebral Body Replacement System | Aesculap, Inc. | 2006 | — |
| −8 | K071983 | Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace… | Aesculap Implant Systems, Inc. | 2008 | 1 |
| −7 | K083311 | Aesculap Cespace Peek Intervertebral Body Fusion System | Aesculap Implant Systems, Inc. | 2009 | — |
| −6 | K100889 | Endoskeleton TC | Titan Spine, LLC | 2010 | — |
| −5 | K121649 | Construx Mini Peek TI Spacer System | Orthofix | 2012 | — |
| −4 | K142152 | Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand Alone System | Orthofix, Inc. | 2015 | — |
| −3 | K161280 | Cervical Stand Alone System | Orthofix, Inc. | 2016 | — |
| −2 | K172424 | Velofix™ SA Cervical Cage | U&I Corporation | 2017 | 1 |
| −1 | K210573 | Velofix SA Cervical Cage | U&I Corporation | 2021 | — |
| 0 (this device) | K262726 | NeckTune™ SA Cervical Cage | Medyssey Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1996 | 2 | 0 |
| 1999 | 3 | 0 |
| 2000 | 1 | 0 |
| 2001 | 8 | 0 |
| 2002 | 10 | 0 |
| 2003 | 13 | 0 |
| 2004 | 14 | 0 |
| 2005 | 10 | 0 |
| 2006 | 2 | 0 |
| 2007 | 12 | 0 |
| 2008 | 16 | 1 |
| 2009 | 13 | 0 |
| 2010 | 5 | 0 |
| 2011 | 4 | 0 |
| 2012 | 3 | 0 |
| 2013 | 3 | 0 |
| 2014 | 4 | 0 |
| 2015 | 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 OVE device
- #1 K241846 E3D™-C Interbody Systemscore 32.1 · 32 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; 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 | K260060 | NeckTune™ 3D SA Cervical Cage Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | |
| Kept off the family tree | K231340 | FDA’s K231340 is Renova Spine Balloon Catheter Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2023 |
| * | K210573 | Velofix SA Cervical CageSummary page 5…O_VE_ ___ _, I K210573 11 Velofix SA Cervical Cage… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
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 25 years and passes through 10 companies; a new generation was cleared every 1.0 years on median.
- 16 of the 143 ancestors have a recall of any class; 1 has a Class I recall.
How does its category compare?
All OVE devicesOVE Intervertebral Fusion Device With Integrated Fixation, Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · OVE
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OVE
105in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OVE
2in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OVE
132in 2025
MAUDE reports naming product code OVE, 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 | 1 | — | 0 | 0 |
| 2008 | 4 | 131 | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 4 | 210 | 0 | 2 |
| 2011 | 8 | 139 | 0 | 19 |
| 2012 | 7 | 125 | 0 | 59 |
| 2013 | 5 | 71 | 1 | 250 |
| 2014 | 11 | 168 | 1 | 150 |
| 2015 | 12 | 113 | 1 | 173 |
| 2016 | 15 | 149 | 1 | 145 |
| 2017 | 9 | 100 | 1 | 134 |
| 2018 | 7 | 105 | 0 | 210 |
| 2019 | 7 | 87 | 0 | 169 |
| 2020 | 13 | 149 | 0 | 162 |
| 2021 | 10 | 93 | 2 | 186 |
| 2022 | 10 | 144 | 0 | 200 |
| 2023 | 16 | 97 | 0 | 148 |
| 2024 | 6 | 56 | 0 | 142 |
| 2025 | 10 | 105 | 0 | 132 |
| 2026 | 13 | 66 | 0 | — |
What is it indicated for?
The NeckTune™ SA Cervical Cage is an anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with associated radicular symptoms at one or two contiguous disc levels from C2—C3 through C7-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. The NeckTune™ SA Cervical Cage is designed for use with allogenic bone graft…
Read the full statement (179 words)
The NeckTune™ SA Cervical Cage is an anterior cervical interbody fusion device indicated for use in
skeletally mature patients with degenerative disc disease (DDD) with associated radicular symptoms at one
or two contiguous disc levels from C2—C3 through C7-T1.
DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and
radiographic studies.
The NeckTune™ SA Cervical Cage is designed for use with allogenic bone graft comprised of cancellous
and/or corticocancellous bone graft and/or autograft to facilitate fusion.
The cage is intended to be used with the two provided fixation screws and, when used as intended,
functions as a stand-alone interbody fusion device.
For cages with a lordotic angle of 20° or greater, use in the cervical spine requires combination with a
legally marketed supplemental fixation system (e.g., cervical plates or cervical posterior fixation).
If the physician chooses to use the cage with fewer than two (2) screws, a legally marketed supplemental
fixation system must be used.
Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an
intervertebral cage.
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/K262726 · printed Nov 6, 2026
Cite this page
510(k) Report. “K262726: NeckTune™ SA Cervical Cage.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K262726
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026