510(k) · Cleared
ClearedIdys® C ZP 3DTi
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Clariance · OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
Cleared on Mar 22, 2024 as substantially equivalent to K212562 (Clariance, SA, 2021) and 1 other predicate after a 7-day review. Its family tree reaches back 20 generations to 2001. 1 of the 245 devices in its family, counting itself, has a Class I recall.
- Decided
- Mar 22, 2024
- Review
- 7 days
- Class
- Class II
- Product code
- OVE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 20 generations to K003155 (2001). 244 ancestors in all, the oldest K792352 (1979). No later device cites it as a predicate yet. 1 of the 245 devices in this family, counting this one, has a Class I recall.
- Root · 20 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 16 generations between
- 3 generations backK192168 Idys ALIF ZP 3DTiClariance, Sas · 2019
- 2 generations backK200920 Idys ALIF ZP 3DTiClariance, Sas · 2020
- 1 generation backK212562 Idys-C ZP 3DTiClariance, SA · 2021
- This deviceK240715 Idys® C ZP 3DTiClariance · 2024
Show all 20 generations
- Root · 20 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 19 generations backK012254 VBROsteotech, Inc. · 2001
- 18 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 17 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 16 generations backK030601 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 15 generations backK040536 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 14 generations backK041556 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 13 generations backK043561 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 12 generations backK060719 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
- 11 generations backK062133 Modification to Verte-Stack Spinal SystemMedtronic Spinal and Biologics Div · 2006
- 10 generations backK070173 Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc. · 2007
- 9 generations backK073285 Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek USA, Inc. · 2008
- 8 generations backK100214 Cornerstone PSR Cervical Interbody Fusion DeviceMedtronic Sofamor Danek · 2010
- 7 generations backK111264 Cornerstone (R) PSR Cervical Fusion SystemMedtronic Sofamor Danek USA · 2011
- 6 generations backK122037 Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion…Medtronic Sofamor Danek, Inc. · 2013
- 5 generations backK150135 DIVERGENCE-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc. · 2015
- 4 generations backK172083 Idys™ ALIF SystemClariance, Sas · 2017
- 3 generations backK192168 Idys ALIF ZP 3DTiClariance, Sas · 2019
- 2 generations backK200920 Idys ALIF ZP 3DTiClariance, Sas · 2020
- 1 generation backK212562 Idys-C ZP 3DTiClariance, SA · 2021
- This deviceK240715 Idys® C ZP 3DTiClariance · 2024
Class I recalls in this family
- K073202 Ardis Spacer7 generations back · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −20 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −19 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −18 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −17 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −16 | K030601 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −15 | K040536 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −14 | K041556 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −13 | K043561 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −12 | K060719 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −11 | K062133 | Modification to Verte-Stack Spinal System | Medtronic Spinal and Biologics Div | 2006 | — |
| −10 | K070173 | Verte-Stack Spinal System | Medtronic Sofamor Danek, Inc. | 2007 | — |
| −9 | K073285 | Peek Prevail Cervical Interbody Device | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −8 | K100214 | Cornerstone PSR Cervical Interbody Fusion Device | Medtronic Sofamor Danek | 2010 | — |
| −7 | K111264 | Cornerstone (R) PSR Cervical Fusion System | Medtronic Sofamor Danek USA | 2011 | — |
| −6 | K122037 | Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System… | Medtronic Sofamor Danek, Inc. | 2013 | — |
| −5 | K150135 | DIVERGENCE-L Anterior/Oblique Lumbar Fusion System | Medtronic Sofamor Danek USA, Inc. | 2015 | — |
| −4 | K172083 | Idys™ ALIF System | Clariance, Sas | 2017 | — |
| −3 | K192168 | Idys ALIF ZP 3DTi | Clariance, Sas | 2019 | — |
| −2 | K200920 | Idys ALIF ZP 3DTi | Clariance, Sas | 2020 | — |
| −1 | K212562 | Idys-C ZP 3DTi | Clariance, SA | 2021 | — |
| 0 (this device) | K240715 | Idys® C ZP 3DTi | Clariance | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1984 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1996 | 6 | 0 |
| 1998 | 1 | 0 |
| 1999 | 4 | 0 |
| 2000 | 2 | 0 |
| 2001 | 12 | 0 |
| 2002 | 10 | 0 |
| 2003 | 17 | 0 |
| 2004 | 25 | 0 |
| 2005 | 17 | 0 |
| 2006 | 6 | 0 |
| 2007 | 16 | 0 |
| 2008 | 34 | 1 |
| 2009 | 15 | 0 |
| 2010 | 10 | 0 |
| 2011 | 17 | 0 |
| 2012 | 11 | 0 |
| 2013 | 10 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2017 | 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 |
|---|---|---|---|
| * | K212562 | Idys-C ZP 3DTiSummary page 4…Classification Name: Intervertebral Body Fusion Device, 21 CFR 888.3080 Regulatory Class: Class II Product Code: OVE Primary Predicate: IDYS® C ZP 3DTi, CLARIANCE (K212562) Additional Predicate: Vault C Standalone Cervical Interbody Fusion System (K132029) Device Description The Idys® C ZP… | 2021 |
| * | K132029 | Vault-C Intervertebral Body Fusion DeviceSummary page 4…Class: Class II Product Code: OVE Primary Predicate: IDYS® C ZP 3DTi, CLARIANCE (K212562) Additional Predicate: Vault C Standalone Cervical Interbody Fusion System (K132029) Device Description The Idys® C ZP 3DTi device consists of a cervical intervertebral body fusion system. The devi… | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
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 · 7 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 23 years and passes through 9 companies; a new generation was cleared every 1.2 years on median.
- 29 of the 244 ancestors have a recall of any class; 1 has a Class I recall.
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. 2024, 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 Idys®-C ZP 3DTi device is indicated for cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one (1) or more levels from C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as 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. This device…
Read the full statement (132 words)
The Idys®-C ZP 3DTi device is indicated for cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one (1) or more levels from C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as 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. This device is to be used in patients who have had at least six (6) weeks of non-operative treatment. The Idys®-C ZP 3DTi device must be used with the integrated fixation screws provided. The Idys®-C ZP 3DTi device must be filled with autograft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone graft. The Idys®-C ZP 3DTi device is to be implanted via an open, anterior approach.
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/K240715 · printed Nov 5, 2026
Cite this page
510(k) Report. “K240715: Idys® C ZP 3DTi.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K240715
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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