510(k) · Cleared
ClearedVelofixtm 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 Mar 5, 2014 as substantially equivalent to K122872 (Dio Medical Co., Ltd., 2013) and 3 other predicates after a 168-day review. Its family tree reaches back 13 generations to 2001. 10 later devices descend from it.
- Decided
- Mar 5, 2014
- Review
- 168 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 13 generations to K003155 (2001). 92 ancestors in all, the oldest K841189 (1984). 10 later devices descend from it, 4 citing it directly.
- Root · 13 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 9 generations between
- 3 generations backK071983 Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace…Aesculap Implant Systems, Inc. · 2008 · Recalled
- 2 generations backK111820 Synster Cervical Cage, Alif Cage, Plif Cage, Ptlif Cage, Tlif CageBm Korea Co., Ltd. · 2012
- 1 generation backK122872 Intervertebral Body Fusion DeviceDio Medical Co., Ltd. · 2013
- This deviceK132926 Velofixtm Interbody Fusion SystemU&I Corp. · 2014
- Descendant · cites it directly · 9 of its ownK140864 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
Show all 13 generations
- Root · 13 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 12 generations backK012254 VBROsteotech, Inc. · 2001
- 11 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 10 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 9 generations backK031780 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 8 generations backK040731 Stryker Spine Vertebral SpacerStryker Spine · 2004
- 7 generations backK042571 Stryker Spine Avs TL Peek SpacerStryker Spine · 2005
- 6 generations backK050624 Stryker Spine Avs PL Peek SpacerStryker Spine · 2005
- 5 generations backK051205 Stryker Spine Avs Asl Peek SpacerStryker Spine · 2005
- 4 generations backK060762 Aesculap Peek Vertebral Body Replacement SystemAesculap, Inc. · 2006
- 3 generations backK071983 Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace…Aesculap Implant Systems, Inc. · 2008 · Recalled
- 2 generations backK111820 Synster Cervical Cage, Alif Cage, Plif Cage, Ptlif Cage, Tlif CageBm Korea Co., Ltd. · 2012
- 1 generation backK122872 Intervertebral Body Fusion DeviceDio Medical Co., Ltd. · 2013
- This deviceK132926 Velofixtm Interbody Fusion SystemU&I Corp. · 2014
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K140864Veloxtm Interbody Fusion SystemU&I Corp. · 2014 · cites it directly9descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −12 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −11 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −10 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −9 | K031780 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −8 | K040731 | Stryker Spine Vertebral Spacer | Stryker Spine | 2004 | — |
| −7 | K042571 | Stryker Spine Avs TL Peek Spacer | Stryker Spine | 2005 | — |
| −6 | K050624 | Stryker Spine Avs PL Peek Spacer | Stryker Spine | 2005 | — |
| −5 | K051205 | Stryker Spine Avs Asl Peek Spacer | Stryker Spine | 2005 | — |
| −4 | K060762 | Aesculap Peek Vertebral Body Replacement System | Aesculap, Inc. | 2006 | — |
| −3 | K071983 | Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace… | Aesculap Implant Systems, Inc. | 2008 | 1 |
| −2 | K111820 | Synster Cervical Cage, Alif Cage, Plif Cage, Ptlif Cage, Tlif Cage | Bm Korea Co., Ltd. | 2012 | — |
| −1 | K122872 | Intervertebral Body Fusion Device | Dio Medical Co., Ltd. | 2013 | — |
| 0 (this device) | K132926 | Velofixtm Interbody Fusion System | U&I Corp. | 2014 | — |
| +1 | 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 | — |
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 |
|---|---|---|
| 2014 | 1 | 0 |
| 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? (4)
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 |
|---|---|---|---|
| * | K122872 | Intervertebral Body Fusion DeviceSummary page 1…Common Name: Intervertebral Body Fusion Device, IBF Device Product Code: ODPR MAX Predicate Devices: Galaxy (ACIF, PLIF, TLIF) PEEK Cage (K1 22872) BAK/Cervical Interbody Fusion System (P3980048) C-Thrum Anterior Spinal System… | 2013 |
| * | P980048 | Bak/Cervical (Bak/C) Interbody Fusion SystemSummary page 2…l Equivalence: The VelofixTM Interbody Fusion System is substantially equivalent to Galaxy (ACIF, PLIF, TLIF) PEEK Cage (K122872), BAK/Cervical Interbody Fusion System (P980048), C-ThruTm Anterior Spinal System (K092336), Capstone Spinal System (K082342) in design, material, mechanical performance, functi… | 2001 |
| * | K092336 | C-Thru Spinal SystemSummary page 1…(ACIF, PLIF, TLIF) PEEK Cage (K1 22872) BAK/Cervical Interbody Fusion System (P3980048) C-Thrum Anterior Spinal System (K092336) Capstone Spinal System (K082342) Description of Device: The VelofixTM Interbody Fusion System consis… | 2009 |
| * | K082342 | Modification to Capstone Spinal SystemSummary page 1…BAK/Cervical Interbody Fusion System (P3980048) C-Thrum Anterior Spinal System (K092336) Capstone Spinal System (K082342) Description of Device: The VelofixTM Interbody Fusion System consists of implants available in various heights, width and ang… | 2008 |
What descends from it? (10)
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?
- 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 92 ancestors have a recall of any class.
- Of its descendants, K140864 (U&I Corp., 2014) has gone furthest, with 9 descendants of its own.
- 5 other devices also cite its predicate K122872.
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 VelofiXTM PEEK Cervical 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 system is designed for use with supplemental fixation and with autograft to…
Read the full statement (180 words)
The VelofiXTM PEEK Cervical 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 system is designed for use with supplemental fixation and with autograft to facilitate fusion. Patients should have at least six weeks of non-operative treatment prior to treatment with an intervertebral cage.
The VelofixTM PEEK Lumbar Cage is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two levels for L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months 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/K132926 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132926: Velofixtm 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/K132926
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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