510(k) · Cleared
ClearedVelofix SA Cervical Cage
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
U&I Corporation · OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
Cleared on Nov 19, 2021 as substantially equivalent to K172424 (U&I Corporation, 2017) and 1 other predicate after a 266-day review. Its family tree reaches back 17 generations to 2001. 1 of the 144 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Nov 19, 2021
- Review
- 266 days
- Class
- Class II
- Product code
- OVE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 17 generations to K003155 (2001). 142 ancestors in all, the oldest K841189 (1984). 1 later device descends from it, 1 citing it directly. 1 of the 144 devices in this family, counting this one, has a Class I recall.
- Root · 17 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 13 generations between
- 3 generations backK142152 Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand…Orthofix, Inc. · 2015
- 2 generations backK161280 Cervical Stand Alone SystemOrthofix, Inc. · 2016
- 1 generation backK172424 Velofix™ SA Cervical CageU&I Corporation · 2017 · Recalled
- This deviceK210573 Velofix SA Cervical CageU&I Corporation · 2021
- Descendant · cites it directly · 0 of its ownK262726 NeckTune™ SA Cervical CageMedyssey Co., Ltd. · 2026
Show all 17 generations
- Root · 17 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 16 generations backK012254 VBROsteotech, Inc. · 2001
- 15 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 14 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 13 generations backK031780 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 12 generations backK040731 Stryker Spine Vertebral SpacerStryker Spine · 2004
- 11 generations backK042571 Stryker Spine Avs TL Peek SpacerStryker Spine · 2005
- 10 generations backK050624 Stryker Spine Avs PL Peek SpacerStryker Spine · 2005
- 9 generations backK051205 Stryker Spine Avs Asl Peek SpacerStryker Spine · 2005
- 8 generations backK060762 Aesculap Peek Vertebral Body Replacement SystemAesculap, Inc. · 2006
- 7 generations backK071983 Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace…Aesculap Implant Systems, Inc. · 2008 · Recalled
- 6 generations backK083311 Aesculap Cespace Peek Intervertebral Body Fusion SystemAesculap Implant Systems, Inc. · 2009
- 5 generations backK100889 Endoskeleton TCTitan Spine, LLC · 2010
- 4 generations backK121649 Construx Mini Peek TI Spacer SystemOrthofix · 2012
- 3 generations backK142152 Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand…Orthofix, Inc. · 2015
- 2 generations backK161280 Cervical Stand Alone SystemOrthofix, Inc. · 2016
- 1 generation backK172424 Velofix™ SA Cervical CageU&I Corporation · 2017 · Recalled
- This deviceK210573 Velofix SA Cervical CageU&I Corporation · 2021
Class I recalls in this family
- K073202 Ardis Spacer4 generations back · 2008
Most influential descendants
Showing 1 of 1 · See all- K262726NeckTune™ SA Cervical CageMedyssey Co., Ltd. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −16 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −15 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −14 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −13 | K031780 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −12 | K040731 | Stryker Spine Vertebral Spacer | Stryker Spine | 2004 | — |
| −11 | K042571 | Stryker Spine Avs TL Peek Spacer | Stryker Spine | 2005 | — |
| −10 | K050624 | Stryker Spine Avs PL Peek Spacer | Stryker Spine | 2005 | — |
| −9 | K051205 | Stryker Spine Avs Asl Peek Spacer | Stryker Spine | 2005 | — |
| −8 | K060762 | Aesculap Peek Vertebral Body Replacement System | Aesculap, Inc. | 2006 | — |
| −7 | K071983 | Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace… | Aesculap Implant Systems, Inc. | 2008 | 1 |
| −6 | K083311 | Aesculap Cespace Peek Intervertebral Body Fusion System | Aesculap Implant Systems, Inc. | 2009 | — |
| −5 | K100889 | Endoskeleton TC | Titan Spine, LLC | 2010 | — |
| −4 | K121649 | Construx Mini Peek TI Spacer System | Orthofix | 2012 | — |
| −3 | K142152 | Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand Alone System | Orthofix, Inc. | 2015 | — |
| −2 | K161280 | Cervical Stand Alone System | Orthofix, Inc. | 2016 | — |
| −1 | K172424 | Velofix™ SA Cervical Cage | U&I Corporation | 2017 | 1 |
| 0 (this device) | K210573 | Velofix SA Cervical Cage | U&I Corporation | 2021 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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? (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 |
|---|---|---|---|
| * | K172424 | Velofix™ SA Cervical CageSummary page 4…888.3080 Common Name: Intervertebral Body Fusion Device, IBF Device Product Code: OVE Predicate Devices: Primary - VelofixTM SA Cervical Cage (K172424) Additional - Galaxy (ACIF, PLIF, TLIF and ALIF) Peek cage (K122872) Purpose of submission: This submission is to add new devi… | 2017 |
| * | K122872 | Intervertebral Body Fusion DeviceSummary page 4…IBF Device Product Code: OVE Predicate Devices: Primary - VelofixTM SA Cervical Cage (K172424) Additional - Galaxy (ACIF, PLIF, TLIF and ALIF) Peek cage (K122872) Purpose of submission: This submission is to add new device to the original device, which the assembly method of spacers and p… | 2013 |
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 |
|---|---|---|---|
| K262726 | NeckTune™ SA Cervical Cage | 2026 | 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 · 4 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 20 years and passes through 9 companies; a new generation was cleared every 10 months on median.
- 16 of the 142 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K262726 (Medyssey Co., Ltd., 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K172424.
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. 2021, 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 Velofix™ SA Cervical Cage is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic…
Read the full statement (136 words)
The Velofix™ SA Cervical Cage is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. The Velofix™ SA Cervical Cage implants are to be used with either autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, and implanted via an open, anterior approach. The Velofix™ SA Cervical Cage must be used with the internal screw fixation provided by screws of the Velofix™ SA Cervical Cage. This cervical device is to be used in patients who have had six weeks of non-operative treatment.
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/K210573 · printed Nov 3, 2026
Cite this page
510(k) Report. “K210573: Velofix SA Cervical Cage.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K210573
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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