510(k) · Cleared
ClearedIdys ALIF ZP 3DTi
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Clariance, Sas · OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Cleared on Nov 4, 2019 as substantially equivalent to K172083 (Clariance, Sas, 2017) and 1 other predicate after an 87-day review. Its family tree reaches back 17 generations to 2001. 1 of the 215 devices in its family, counting itself, has a Class I recall. 5 later devices descend from it.
- Decided
- Nov 4, 2019
- Review
- 87 days
- Class
- Class II
- Product code
- OVD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 17 generations to K003155 (2001). 209 ancestors in all, the oldest K792352 (1979). 5 later devices descend from it, 2 citing it directly. 1 of the 215 devices in this family, counting this one, has a Class I recall.
- Root · 17 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 13 generations between
- 3 generations backK122037 Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion…Medtronic Sofamor Danek, Inc. · 2013
- 2 generations backK150135 DIVERGENCE-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc. · 2015
- 1 generation backK172083 Idys™ ALIF SystemClariance, Sas · 2017
- This deviceK192168 Idys ALIF ZP 3DTiClariance, Sas · 2019
- Descendant · cites it directly · 3 of its ownK200920 Idys ALIF ZP 3DTiClariance, Sas · 2020
- Descendant · 2 generations on · 1 of its ownK212562 Idys-C ZP 3DTiClariance, SA · 2021
- Descendant · 3 generations on · 0 of its ownK240715 Idys® C ZP 3DTiClariance · 2024
- Descendant · cites it directly · 0 of its ownK200919 Idys ALIF 3DTiClariance · 2021
- Descendant · 2 generations on · 0 of its ownK202032 Idys LLIF 3DTiClariance, Sas · 2021
Show all 17 generations
- Root · 17 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 16 generations backK012254 VBROsteotech, Inc. · 2001
- 15 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 14 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 13 generations backK030601 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 12 generations backK040536 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 11 generations backK041556 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 10 generations backK043561 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 9 generations backK060719 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
- 8 generations backK062133 Modification to Verte-Stack Spinal SystemMedtronic Spinal and Biologics Div · 2006
- 7 generations backK070173 Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc. · 2007
- 6 generations backK073285 Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek USA, Inc. · 2008
- 5 generations backK100214 Cornerstone PSR Cervical Interbody Fusion DeviceMedtronic Sofamor Danek · 2010
- 4 generations backK111264 Cornerstone (R) PSR Cervical Fusion SystemMedtronic Sofamor Danek USA · 2011
- 3 generations backK122037 Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion…Medtronic Sofamor Danek, Inc. · 2013
- 2 generations backK150135 DIVERGENCE-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc. · 2015
- 1 generation backK172083 Idys™ ALIF SystemClariance, Sas · 2017
- This deviceK192168 Idys ALIF ZP 3DTiClariance, Sas · 2019
Class I recalls in this family
- K073202 Ardis Spacer4 generations back · 2008
Most influential descendants
Showing 5 of 5 · See all- K200920Idys ALIF ZP 3DTiClariance, Sas · 2020 · cites it directly3descendants
- K212562Idys-C ZP 3DTiClariance, SA · 2021 · 2 generations on1descendant
- K240715Idys® C ZP 3DTiClariance · 2024 · 3 generations on0descendants
- K200919Idys ALIF 3DTiClariance · 2021 · cites it directly0descendants
- K202032Idys LLIF 3DTiClariance, Sas · 2021 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −16 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −15 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −14 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −13 | K030601 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −12 | K040536 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −11 | K041556 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −10 | K043561 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −9 | K060719 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −8 | K062133 | Modification to Verte-Stack Spinal System | Medtronic Spinal and Biologics Div | 2006 | — |
| −7 | K070173 | Verte-Stack Spinal System | Medtronic Sofamor Danek, Inc. | 2007 | — |
| −6 | K073285 | Peek Prevail Cervical Interbody Device | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −5 | K100214 | Cornerstone PSR Cervical Interbody Fusion Device | Medtronic Sofamor Danek | 2010 | — |
| −4 | K111264 | Cornerstone (R) PSR Cervical Fusion System | Medtronic Sofamor Danek USA | 2011 | — |
| −3 | K122037 | Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System… | Medtronic Sofamor Danek, Inc. | 2013 | — |
| −2 | K150135 | DIVERGENCE-L Anterior/Oblique Lumbar Fusion System | Medtronic Sofamor Danek USA, Inc. | 2015 | — |
| −1 | K172083 | Idys™ ALIF System | Clariance, Sas | 2017 | — |
| 0 (this device) | K192168 | Idys ALIF ZP 3DTi | Clariance, Sas | 2019 | — |
| +1 | K200920 | Idys ALIF ZP 3DTi | Clariance, Sas | 2020 | — |
| +2 | K212562 | Idys-C ZP 3DTi | Clariance, SA | 2021 | — |
| +3 | K240715 | Idys® C ZP 3DTi | Clariance | 2024 | — |
| +1 | K200919 | Idys ALIF 3DTi | Clariance | 2021 | — |
| +2 | K202032 | Idys LLIF 3DTi | Clariance, Sas | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1984 | 1 | 0 |
| 1993 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 4 | 0 |
| 2000 | 1 | 0 |
| 2001 | 10 | 0 |
| 2002 | 8 | 0 |
| 2003 | 16 | 0 |
| 2004 | 24 | 0 |
| 2005 | 16 | 0 |
| 2006 | 6 | 0 |
| 2007 | 14 | 0 |
| 2008 | 31 | 1 |
| 2009 | 13 | 0 |
| 2010 | 8 | 0 |
| 2011 | 14 | 0 |
| 2012 | 8 | 0 |
| 2013 | 8 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2024 | 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 OVD device
- #1 K222009 aprevo® anterior lumbar interbody fusion…score 26.0 · 23 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 |
|---|---|---|---|
| * | K172083 | Idys™ ALIF SystemSummary page 4…Integrated Fixation Classification Name Class II, 21 CFR §888.3080 - Intervertebral body fusion device, OVD Predicate Devices Idys® ALIF, CLARIANCE SAS (K172083): primary predicate Idys® TLIF 3DTi, CLARIANCE SAS (K172465): additional predicate Purpose of the 510(k) Notice… | 2017 |
| * | K172465 | Idys™ TLIF 3DTi CagesSummary page 4…ervertebral body fusion device, OVD Predicate Devices Idys® ALIF, CLARIANCE SAS (K172083): primary predicate Idys® TLIF 3DTi, CLARIANCE SAS (K172465): additional predicate Purpose of the 510(k) Notice The Idys® ALIF ZP 3DTi device is a modification of the 510(k) approved… | 2017 |
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)
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 · 4 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 18 years and passes through 7 companies; a new generation was cleared every 1.1 years on median.
- 21 of the 209 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K200920 (Clariance, Sas, 2020) has gone furthest, with 3 descendants of its own.
- 4 other devices also cite its predicate K172083.
How does its category compare?
All OVD devicesOVD Intervertebral Fusion Device With Integrated Fixation, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · OVD
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OVD
100in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OVD
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OVD
50in 2025
MAUDE reports naming product code OVD, 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 | 2 | — | 0 | 0 |
| 2008 | 8 | 84 | 0 | 0 |
| 2009 | 3 | 152 | 0 | 2 |
| 2010 | 8 | 117 | 0 | 2 |
| 2011 | 9 | 167 | 0 | 6 |
| 2012 | 10 | 78 | 0 | 16 |
| 2013 | 11 | 137 | 4 | 17 |
| 2014 | 14 | 139 | 0 | 35 |
| 2015 | 12 | 166 | 0 | 43 |
| 2016 | 13 | 127 | 1 | 55 |
| 2017 | 12 | 127 | 0 | 72 |
| 2018 | 14 | 126 | 0 | 112 |
| 2019 | 12 | 91 | 0 | 171 |
| 2020 | 14 | 91 | 0 | 203 |
| 2021 | 7 | 108 | 1 | 221 |
| 2022 | 14 | 133 | 1 | 74 |
| 2023 | 12 | 92 | 0 | 67 |
| 2024 | 12 | 110 | 0 | 92 |
| 2025 | 10 | 100 | 1 | 50 |
| 2026 | 8 | 93 | 1 | — |
What is it indicated for?
The Idys® ALIF ZP 3DTi devices (Anterior Lumbar Interbody Fusion) are intended for use in patients with degenerative disc disease (DDD) at one (1) or (2) contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as back pain in discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. These patients…
Read the full statement (115 words)
The Idys® ALIF ZP 3DTi devices (Anterior Lumbar Interbody Fusion) are intended for use in patients with degenerative disc disease (DDD) at one (1) or (2) contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as back pain in discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. The Idys® ALIF ZP 3DTi cages should be used with the integrated fixation screws provided.
The Idys® ALIF ZP 3DTi cages are intended to be used with autograft.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192168 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192168: Idys ALIF ZP 3DTi.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192168
Report an extraction error
Are you the manufacturer?
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