510(k) · Cleared
ClearedVeloxtm Interbody Fusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
U&I Corp. · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on Jul 22, 2014 as substantially equivalent to K132926 (U&I Corp., 2014) and 2 other predicates after a 110-day review. Its family tree reaches back 14 generations to 2001. 9 later devices descend from it.
- Decided
- Jul 22, 2014
- Review
- 110 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 14 generations to K003155 (2001). 93 ancestors in all, the oldest K841189 (1984). 9 later devices descend from it, 3 citing it directly.
- Root · 14 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 10 generations between
- 3 generations backK111820 Synster Cervical Cage, Alif Cage, Plif Cage, Ptlif Cage, Tlif CageBm Korea Co., Ltd. · 2012
- 2 generations backK122872 Intervertebral Body Fusion DeviceDio Medical Co., Ltd. · 2013
- 1 generation backK132926 Velofixtm Interbody Fusion SystemU&I Corp. · 2014
- This deviceK140864 Veloxtm Interbody Fusion SystemU&I Corp. · 2014
- Descendant · cites it directly · 5 of its ownK171749 Velofix (tm) Interbody Fusion SystemU&I Corporation · 2017
- Descendant · 2 generations on · 3 of its ownK190067 Velofix Interbody Fusion SystemU&I Corporation · 2019
- Descendant · 3 generations on · 2 of its ownK213791 Unispace SA Cervical CageEdisoninno Co., Ltd. · 2022
- Descendant · cites it directly · 2 of its ownK172419 Velofix™ TLIF CageU&I Corporation · 2017
- Descendant · 4 generations on · 1 of its ownK234119 UniSpace® Stand-Alone C CageInnosys Co., Ltd. · 2024
Show all 14 generations
- Root · 14 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 13 generations backK012254 VBROsteotech, Inc. · 2001
- 12 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 11 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 10 generations backK031780 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 9 generations backK040731 Stryker Spine Vertebral SpacerStryker Spine · 2004
- 8 generations backK042571 Stryker Spine Avs TL Peek SpacerStryker Spine · 2005
- 7 generations backK050624 Stryker Spine Avs PL Peek SpacerStryker Spine · 2005
- 6 generations backK051205 Stryker Spine Avs Asl Peek SpacerStryker Spine · 2005
- 5 generations backK060762 Aesculap Peek Vertebral Body Replacement SystemAesculap, Inc. · 2006
- 4 generations backK071983 Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace…Aesculap Implant Systems, Inc. · 2008 · Recalled
- 3 generations backK111820 Synster Cervical Cage, Alif Cage, Plif Cage, Ptlif Cage, Tlif CageBm Korea Co., Ltd. · 2012
- 2 generations backK122872 Intervertebral Body Fusion DeviceDio Medical Co., Ltd. · 2013
- 1 generation backK132926 Velofixtm Interbody Fusion SystemU&I Corp. · 2014
- This deviceK140864 Veloxtm Interbody Fusion SystemU&I Corp. · 2014
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K171749Velofix (tm) Interbody Fusion SystemU&I Corporation · 2017 · cites it directly5descendants
- K190067Velofix Interbody Fusion SystemU&I Corporation · 2019 · 2 generations on3descendants
- K213791Unispace SA Cervical CageEdisoninno Co., Ltd. · 2022 · 3 generations on2descendants
- K172419Velofix™ TLIF CageU&I Corporation · 2017 · cites it directly2descendants
- K234119UniSpace® Stand-Alone C CageInnosys Co., Ltd. · 2024 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −13 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −12 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −11 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −10 | K031780 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −9 | K040731 | Stryker Spine Vertebral Spacer | Stryker Spine | 2004 | — |
| −8 | K042571 | Stryker Spine Avs TL Peek Spacer | Stryker Spine | 2005 | — |
| −7 | K050624 | Stryker Spine Avs PL Peek Spacer | Stryker Spine | 2005 | — |
| −6 | K051205 | Stryker Spine Avs Asl Peek Spacer | Stryker Spine | 2005 | — |
| −5 | K060762 | Aesculap Peek Vertebral Body Replacement System | Aesculap, Inc. | 2006 | — |
| −4 | K071983 | Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace… | Aesculap Implant Systems, Inc. | 2008 | 1 |
| −3 | K111820 | Synster Cervical Cage, Alif Cage, Plif Cage, Ptlif Cage, Tlif Cage | Bm Korea Co., Ltd. | 2012 | — |
| −2 | K122872 | Intervertebral Body Fusion Device | Dio Medical Co., Ltd. | 2013 | — |
| −1 | K132926 | Velofixtm Interbody Fusion System | U&I Corp. | 2014 | — |
| 0 (this device) | K140864 | Veloxtm Interbody Fusion System | U&I Corp. | 2014 | — |
| +1 | K171749 | Velofix (tm) Interbody Fusion System | U&I Corporation | 2017 | — |
| +2 | K190067 | Velofix Interbody Fusion System | U&I Corporation | 2019 | — |
| +3 | K213791 | Unispace SA Cervical Cage | Edisoninno Co., Ltd. | 2022 | — |
| +1 | K172419 | Velofix™ TLIF Cage | U&I Corporation | 2017 | — |
| +4 | K234119 | UniSpace® Stand-Alone C Cage | Innosys Co., Ltd. | 2024 | — |
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 | 5 | 0 |
| 2003 | 8 | 0 |
| 2004 | 16 | 0 |
| 2005 | 6 | 0 |
| 2006 | 1 | 0 |
| 2007 | 7 | 0 |
| 2008 | 9 | 0 |
| 2009 | 9 | 0 |
| 2010 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K132926 | Velofixtm Interbody Fusion SystemSummary page 1…Common Name: Intervertebral Body Fusion Device, IBF Device Product Code: ODP, MAX Predicate Devices: VelofixTM Interbody Fusion System(K1 32926) Galaxy PLIF PEEK Cage (K1 22872) Capstone Spinal System (K082342) Descript… | 2014 |
| * | K122872 | Intervertebral Body Fusion DeviceSummary page 1…e, IBF Device Product Code: ODP, MAX Predicate Devices: VelofixTM Interbody Fusion System(K1 32926) Galaxy PLIF PEEK Cage (K1 22872) Capstone Spinal System (K082342) Description of Device: The VelofixTM Interbody Fusion System(K1 32… | 2013 |
| * | K082342 | Modification to Capstone Spinal SystemSummary page 1…Devices: VelofixTM Interbody Fusion System(K1 32926) Galaxy PLIF PEEK Cage (K1 22872) Capstone Spinal System (K082342) Description of Device: The VelofixTM Interbody Fusion System(K1 32926) consists of implants available in various heights, wid… | 2008 |
What descends from it? (9)
3 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?
- The line of descent spans 13 years and passes through 8 companies; a new generation was cleared every 10 months on median.
- 11 of the 93 ancestors have a recall of any class.
- Of its descendants, K171749 (U&I Corporation, 2017) has gone furthest, with 5 descendants of its own.
- 3 other devices also cite its predicate K132926.
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. 2014, 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 VelotixTM PEEK Cervical Cage is indicated for interveriebral body fusion in skelctally mature patients with degenerative disc disease (DIDD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-CJ disc to the C7-T I disc. DOD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft…
Read the full statement (182 words)
The VelotixTM PEEK Cervical Cage is indicated for interveriebral body fusion in skelctally mature patients with degenerative disc disease (DIDD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-CJ disc to the C7-T I disc. DOD is defined as discogenic pain 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 to facilitate fusion. Patients should have at least six wveeks of non-operative treatment prior to treatment with an intervertebral cag.
Thle VelofixTMV PEEK Lumbar Cage is indicated for use wvith aulogenous hone grafl in patients with degenerative disc disease(DDD) at one or two levels for 1,2 to S I. These l)DD patients may also have tip to Grade I Spondylolisthesis or retrolithiesis at the involved levels. OIDD is defined as back pain of discongenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six mionths of non-operative treatment. These devices are intended to be used with supplemental fixation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140864 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140864: Veloxtm Interbody Fusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140864
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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