510(k) · Cleared
ClearedCervical Stand Alone System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthofix, Inc. · OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
Cleared on Jun 17, 2016 as substantially equivalent to K142152 (Orthofix, Inc., 2015) after a 42-day review. Its family tree reaches back 15 generations to 2001. 14 later devices descend from it.
- Decided
- Jun 17, 2016
- Review
- 42 days
- Class
- Class II
- Product code
- OVE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 15 generations to K003155 (2001). 90 ancestors in all, the oldest K841189 (1984). 14 later devices descend from it, 3 citing it directly.
- Root · 15 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 11 generations between
- 3 generations backK100889 Endoskeleton TCTitan Spine, LLC · 2010
- 2 generations backK121649 Construx Mini Peek TI Spacer SystemOrthofix · 2012
- 1 generation backK142152 Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand…Orthofix, Inc. · 2015
- This deviceK161280 Cervical Stand Alone SystemOrthofix, Inc. · 2016
- Descendant · cites it directly · 5 of its ownK211704 CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System…Orthofix, Inc. · 2021
- Descendant · cites it directly · 5 of its ownK172424 Velofix™ SA Cervical CageU&I Corporation · 2017 · Recalled
- Descendant · 2 generations on · 4 of its ownK213951 FORZA XP Expandable Spacer SystemOrthofix US, LLC · 2022
- Descendant · 3 generations on · 2 of its ownK240830 Reef TO/TA System; Regatta Lateral System; Explorer TO System…Orthofix Medical, Inc. · 2024
- Descendant · 2 generations on · 2 of its ownK213791 Unispace SA Cervical CageEdisoninno Co., Ltd. · 2022
Show all 15 generations
- Root · 15 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 14 generations backK012254 VBROsteotech, Inc. · 2001
- 13 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 12 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 11 generations backK031780 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 10 generations backK040731 Stryker Spine Vertebral SpacerStryker Spine · 2004
- 9 generations backK042571 Stryker Spine Avs TL Peek SpacerStryker Spine · 2005
- 8 generations backK050624 Stryker Spine Avs PL Peek SpacerStryker Spine · 2005
- 7 generations backK051205 Stryker Spine Avs Asl Peek SpacerStryker Spine · 2005
- 6 generations backK060762 Aesculap Peek Vertebral Body Replacement SystemAesculap, Inc. · 2006
- 5 generations backK071983 Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace…Aesculap Implant Systems, Inc. · 2008 · Recalled
- 4 generations backK083311 Aesculap Cespace Peek Intervertebral Body Fusion SystemAesculap Implant Systems, Inc. · 2009
- 3 generations backK100889 Endoskeleton TCTitan Spine, LLC · 2010
- 2 generations backK121649 Construx Mini Peek TI Spacer SystemOrthofix · 2012
- 1 generation backK142152 Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand…Orthofix, Inc. · 2015
- This deviceK161280 Cervical Stand Alone SystemOrthofix, Inc. · 2016
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K211704CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer…Orthofix, Inc. · 2021 · cites it directly5descendants
- K172424Velofix™ SA Cervical CageU&I Corporation · 2017 · cites it directly5descendants
- K213951FORZA XP Expandable Spacer SystemOrthofix US, LLC · 2022 · 2 generations on4descendants
- K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc. · 2024 · 3 generations on2descendants
- K213791Unispace SA Cervical CageEdisoninno Co., Ltd. · 2022 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −14 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −13 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −12 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −11 | K031780 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −10 | K040731 | Stryker Spine Vertebral Spacer | Stryker Spine | 2004 | — |
| −9 | K042571 | Stryker Spine Avs TL Peek Spacer | Stryker Spine | 2005 | — |
| −8 | K050624 | Stryker Spine Avs PL Peek Spacer | Stryker Spine | 2005 | — |
| −7 | K051205 | Stryker Spine Avs Asl Peek Spacer | Stryker Spine | 2005 | — |
| −6 | K060762 | Aesculap Peek Vertebral Body Replacement System | Aesculap, Inc. | 2006 | — |
| −5 | K071983 | Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace… | Aesculap Implant Systems, Inc. | 2008 | 1 |
| −4 | K083311 | Aesculap Cespace Peek Intervertebral Body Fusion System | Aesculap Implant Systems, Inc. | 2009 | — |
| −3 | K100889 | Endoskeleton TC | Titan Spine, LLC | 2010 | — |
| −2 | K121649 | Construx Mini Peek TI Spacer System | Orthofix | 2012 | — |
| −1 | K142152 | Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand Alone System | Orthofix, Inc. | 2015 | — |
| 0 (this device) | K161280 | Cervical Stand Alone System | Orthofix, Inc. | 2016 | — |
| +1 | K211704 | CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini… | Orthofix, Inc. | 2021 | — |
| +1 | K172424 | Velofix™ SA Cervical Cage | U&I Corporation | 2017 | 1 |
| +2 | K213951 | FORZA XP Expandable Spacer System | Orthofix US, LLC | 2022 | — |
| +3 | K240830 | Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C… | Orthofix Medical, Inc. | 2024 | — |
| +2 | K213791 | Unispace SA Cervical Cage | Edisoninno Co., Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 8 | 0 |
| 2002 | 6 | 0 |
| 2003 | 9 | 0 |
| 2004 | 14 | 0 |
| 2005 | 7 | 0 |
| 2007 | 5 | 0 |
| 2008 | 9 | 0 |
| 2009 | 6 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 3 | 0 |
| 2026 | 2 | 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 OVE? 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? (1)
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 |
|---|---|---|---|
| * | K142152 | Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand Alone SystemSummary page 4…gulatory Classification: Class II – 21 CFR § 888.3080 – Intervertebral body fusion device Review Panel: Orthopedic Device Panel Predicate Devices: K142152 – Cervical Stand Alone, SE 1/8/2015 K150619 – CONSTRUX Mini PEEK Spacer, SE 9/11/2015… | 2015 |
| † | K150619 | CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer System | 2015 |
What descends from it? (14)
See all 143 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 15 years and passes through 8 companies; a new generation was cleared every 10 months on median.
- 6 of the 90 ancestors have a recall of any class.
- Of its descendants, K211704 (Orthofix, Inc., 2021) has gone furthest, with 5 descendants of its own.
- 5 other devices also cite its predicate K142152.
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. 2016, 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 Cervical Stand Alone System is indicated for spinal fusion procedures at one level in the cervical spine (C2-T1), in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies.
The Cervical Stand Alone System is used with autograft and /or allograft comprised of cancellous and/or corticocancellous bone graft and the two titanium alloy screws which accompany the implant.
Patients must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with the Cervical Stand Alone System in the cervical spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161280 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161280: Cervical Stand Alone System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161280
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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