510(k) · Cleared
Recalled · Class II · 2019Velofix™ 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 22, 2017 as substantially equivalent to K102606 (Stryker Spine, 2011) and 5 other predicates after a 104-day review. Its family tree reaches back 16 generations to 2001. 1 of the 147 devices in its family, counting itself, has a Class I recall. 5 later devices descend from it. It has been recalled once.
- Decided
- Nov 22, 2017
- Review
- 104 days
- Class
- Class II
- Product code
- OVE
- Recalls
- 1
- Predicates
- 6
Its longest line of descent runs back 16 generations to K003155 (2001). 141 ancestors in all, the oldest K841189 (1984). 5 later devices descend from it, 2 citing it directly. 1 of the 147 devices in this family, counting this one, has a Class I recall.
- Root · 16 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 12 generations between
- 3 generations backK121649 Construx Mini Peek TI Spacer SystemOrthofix · 2012
- 2 generations backK142152 Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand…Orthofix, Inc. · 2015
- 1 generation backK161280 Cervical Stand Alone SystemOrthofix, Inc. · 2016
- This deviceK172424 Velofix™ SA Cervical CageU&I Corporation · 2017
- Descendant · cites it directly · 2 of its ownK213791 Unispace SA Cervical CageEdisoninno Co., Ltd. · 2022
- Descendant · 2 generations on · 1 of its ownK234119 UniSpace® Stand-Alone C CageInnosys Co., Ltd. · 2024
- Descendant · cites it directly · 1 of its ownK210573 Velofix SA Cervical CageU&I Corporation · 2021
- Descendant · 2 generations on · 0 of its ownK262726 NeckTune™ SA Cervical CageMedyssey Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK252351 UniSpace® TPLIF CageCg Medtech Co., Ltd. · 2025
Show all 16 generations
- Root · 16 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 15 generations backK012254 VBROsteotech, Inc. · 2001
- 14 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 13 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 12 generations backK031780 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 11 generations backK040731 Stryker Spine Vertebral SpacerStryker Spine · 2004
- 10 generations backK042571 Stryker Spine Avs TL Peek SpacerStryker Spine · 2005
- 9 generations backK050624 Stryker Spine Avs PL Peek SpacerStryker Spine · 2005
- 8 generations backK051205 Stryker Spine Avs Asl Peek SpacerStryker Spine · 2005
- 7 generations backK060762 Aesculap Peek Vertebral Body Replacement SystemAesculap, Inc. · 2006
- 6 generations backK071983 Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace…Aesculap Implant Systems, Inc. · 2008 · Recalled
- 5 generations backK083311 Aesculap Cespace Peek Intervertebral Body Fusion SystemAesculap Implant Systems, Inc. · 2009
- 4 generations backK100889 Endoskeleton TCTitan Spine, LLC · 2010
- 3 generations backK121649 Construx Mini Peek TI Spacer SystemOrthofix · 2012
- 2 generations backK142152 Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand…Orthofix, Inc. · 2015
- 1 generation backK161280 Cervical Stand Alone SystemOrthofix, Inc. · 2016
- This deviceK172424 Velofix™ SA Cervical CageU&I Corporation · 2017
Class I recalls in this family
- K073202 Ardis Spacer3 generations back · 2008
Most influential descendants
Showing 5 of 5 · See all- K213791Unispace SA Cervical CageEdisoninno Co., Ltd. · 2022 · cites it directly2descendants
- K234119UniSpace® Stand-Alone C CageInnosys Co., Ltd. · 2024 · 2 generations on1descendant
- K210573Velofix SA Cervical CageU&I Corporation · 2021 · cites it directly1descendant
- K262726NeckTune™ SA Cervical CageMedyssey Co., Ltd. · 2026 · 2 generations on0descendants
- K252351UniSpace® TPLIF CageCg Medtech Co., Ltd. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −15 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −14 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −13 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −12 | K031780 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −11 | K040731 | Stryker Spine Vertebral Spacer | Stryker Spine | 2004 | — |
| −10 | K042571 | Stryker Spine Avs TL Peek Spacer | Stryker Spine | 2005 | — |
| −9 | K050624 | Stryker Spine Avs PL Peek Spacer | Stryker Spine | 2005 | — |
| −8 | K051205 | Stryker Spine Avs Asl Peek Spacer | Stryker Spine | 2005 | — |
| −7 | K060762 | Aesculap Peek Vertebral Body Replacement System | Aesculap, Inc. | 2006 | — |
| −6 | K071983 | Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace… | Aesculap Implant Systems, Inc. | 2008 | 1 |
| −5 | K083311 | Aesculap Cespace Peek Intervertebral Body Fusion System | Aesculap Implant Systems, Inc. | 2009 | — |
| −4 | K100889 | Endoskeleton TC | Titan Spine, LLC | 2010 | — |
| −3 | K121649 | Construx Mini Peek TI Spacer System | Orthofix | 2012 | — |
| −2 | K142152 | Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand Alone System | Orthofix, Inc. | 2015 | — |
| −1 | K161280 | Cervical Stand Alone System | Orthofix, Inc. | 2016 | — |
| 0 (this device) | K172424 | Velofix™ SA Cervical Cage | U&I Corporation | 2017 | — |
| +1 | K213791 | Unispace SA Cervical Cage | Edisoninno Co., Ltd. | 2022 | — |
| +2 | K234119 | UniSpace® Stand-Alone C Cage | Innosys Co., Ltd. | 2024 | — |
| +1 | K210573 | Velofix SA Cervical Cage | U&I Corporation | 2021 | — |
| +2 | K262726 | NeckTune™ SA Cervical Cage | Medyssey Co., Ltd. | 2026 | — |
| +2 | K252351 | UniSpace® TPLIF Cage | Cg Medtech Co., Ltd. | 2025 | — |
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 |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 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? (6)
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 |
|---|---|---|---|
| * | K102606 | Avs Anchor-C Cervical Cage SystemSummary page 4…3080 Common Name: Intervertebral Body Fusion Device, IBF Device Product Code: OVE Primary Predicate: AVS® Anchor-C Cervical Cage System (K102606) Additional Predicates: Galaxy (ACIF, PLIF, TLIF and ALIF) Peek cage (K122872) BAK/C Anterior Cervi… | 2011 |
| * | K122872 | Intervertebral Body Fusion DeviceSummary page 4…uct Code: OVE Primary Predicate: AVS® Anchor-C Cervical Cage System (K102606) Additional Predicates: Galaxy (ACIF, PLIF, TLIF and ALIF) Peek cage (K122872) BAK/C Anterior Cervical Interbody Fusion System (K143297)… | 2013 |
| * | K143297 | Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior Cervical Interbody…Summary page 4…redicates: Galaxy (ACIF, PLIF, TLIF and ALIF) Peek cage (K122872) BAK/C Anterior Cervical Interbody Fusion System (K143297) Synthes Zero-P (K072981) Cervical Stand Alone System (K132999, K161280) Des… | 2015 |
| * | K072981 | Synthes Zero-PSummary page 4…ek cage (K122872) BAK/C Anterior Cervical Interbody Fusion System (K143297) Synthes Zero-P (K072981) Cervical Stand Alone System (K132999, K161280) Description of Device: The VelofixTM SA Cervical Cage… | 2008 |
| * | K132999 | Cervical Stand Alone SystemSummary page 4…cal Interbody Fusion System (K143297) Synthes Zero-P (K072981) Cervical Stand Alone System (K132999, K161280) Description of Device: The VelofixTM SA Cervical Cage consists of cages, screws, locking plate and set screw. The cag… | 2014 |
| * | K161280 | Cervical Stand Alone SystemSummary page 4…body Fusion System (K143297) Synthes Zero-P (K072981) Cervical Stand Alone System (K132999, K161280) Description of Device: The VelofixTM SA Cervical Cage consists of cages, screws, locking plate and set screw. The cages are av… | 2016 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 30, 2019 | Class II | Z-1823-2020 | Employee error | The vertical dimensions of screw-hole position in some standalone cages might be out of range in engineering drawings. A possibility exists of screw pullout, lossening, instability, or less bone-screw engagement than intended by physicians. |
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 · 3 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 16 years and passes through 9 companies; a new generation was cleared every 10 months on median.
- 15 of the 141 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K213791 (Edisoninno Co., Ltd., 2022) has gone furthest, with 2 descendants of its own.
- 16 other devices also cite its predicate K102606.
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. 2017, 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 (124 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 autogenous 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 as stated in the FDA summary.
https://510kreport.com/device/K172424 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172424: Velofix™ 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/K172424
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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