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 · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on May 29, 2020 as substantially equivalent to K192168 (Clariance, Sas, 2019) and 1 other predicate after a 53-day review. Its family tree reaches back 18 generations to 2001. 1 of the 214 devices in its family, counting itself, has a Class I recall. 3 later devices descend from it.
- Decided
- May 29, 2020
- Review
- 53 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 18 generations to K003155 (2001). 210 ancestors in all, the oldest K792352 (1979). 3 later devices descend from it, 2 citing it directly. 1 of the 214 devices in this family, counting this one, has a Class I recall.
- Root · 18 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 14 generations between
- 3 generations backK150135 DIVERGENCE-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc. · 2015
- 2 generations backK172083 Idys™ ALIF SystemClariance, Sas · 2017
- 1 generation backK192168 Idys ALIF ZP 3DTiClariance, Sas · 2019
- This deviceK200920 Idys ALIF ZP 3DTiClariance, Sas · 2020
- Descendant · cites it directly · 1 of its ownK212562 Idys-C ZP 3DTiClariance, SA · 2021
- Descendant · 2 generations on · 0 of its ownK240715 Idys® C ZP 3DTiClariance · 2024
- Descendant · cites it directly · 0 of its ownK202032 Idys LLIF 3DTiClariance, Sas · 2021
Show all 18 generations
- Root · 18 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 17 generations backK012254 VBROsteotech, Inc. · 2001
- 16 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 15 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 14 generations backK030601 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 13 generations backK040536 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 12 generations backK041556 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 11 generations backK043561 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 10 generations backK060719 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
- 9 generations backK062133 Modification to Verte-Stack Spinal SystemMedtronic Spinal and Biologics Div · 2006
- 8 generations backK070173 Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc. · 2007
- 7 generations backK073285 Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek USA, Inc. · 2008
- 6 generations backK100214 Cornerstone PSR Cervical Interbody Fusion DeviceMedtronic Sofamor Danek · 2010
- 5 generations backK111264 Cornerstone (R) PSR Cervical Fusion SystemMedtronic Sofamor Danek USA · 2011
- 4 generations backK122037 Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion…Medtronic Sofamor Danek, Inc. · 2013
- 3 generations backK150135 DIVERGENCE-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc. · 2015
- 2 generations backK172083 Idys™ ALIF SystemClariance, Sas · 2017
- 1 generation backK192168 Idys ALIF ZP 3DTiClariance, Sas · 2019
- This deviceK200920 Idys ALIF ZP 3DTiClariance, Sas · 2020
Class I recalls in this family
- K073202 Ardis Spacer5 generations back · 2008
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −17 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −16 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −15 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −14 | K030601 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −13 | K040536 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −12 | K041556 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −11 | K043561 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −10 | K060719 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −9 | K062133 | Modification to Verte-Stack Spinal System | Medtronic Spinal and Biologics Div | 2006 | — |
| −8 | K070173 | Verte-Stack Spinal System | Medtronic Sofamor Danek, Inc. | 2007 | — |
| −7 | K073285 | Peek Prevail Cervical Interbody Device | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −6 | K100214 | Cornerstone PSR Cervical Interbody Fusion Device | Medtronic Sofamor Danek | 2010 | — |
| −5 | K111264 | Cornerstone (R) PSR Cervical Fusion System | Medtronic Sofamor Danek USA | 2011 | — |
| −4 | K122037 | Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System… | Medtronic Sofamor Danek, Inc. | 2013 | — |
| −3 | K150135 | DIVERGENCE-L Anterior/Oblique Lumbar Fusion System | Medtronic Sofamor Danek USA, Inc. | 2015 | — |
| −2 | K172083 | Idys™ ALIF System | Clariance, Sas | 2017 | — |
| −1 | K192168 | Idys ALIF ZP 3DTi | Clariance, Sas | 2019 | — |
| 0 (this device) | K200920 | Idys ALIF ZP 3DTi | Clariance, Sas | 2020 | — |
| +1 | K212562 | Idys-C ZP 3DTi | Clariance, SA | 2021 | — |
| +2 | K240715 | Idys® C ZP 3DTi | Clariance | 2024 | — |
| +1 | 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 |
|---|---|---|
| 2021 | 2 | 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 MAX device
- #1 K203714 NuVasive Thoracolumbar Interbody Systems…score 102.5 · 24 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 |
|---|---|---|---|
| * | K192168 | Idys ALIF ZP 3DTiSummary page 4…Bone Graft Classification Name: Class II, 21 CFR §888.3080 - Intervertebral body fusion device, MAX Predicate Devices Idys® ALIF ZP 3DTi, CLARIANCE SAS (K192168): primary predicate Idys® ALIF System, CLARIANCE SAS (K172083): additional predicate (materials and instruments)… | 2019 |
| * | K172083 | Idys™ ALIF SystemSummary page 4…Intervertebral body fusion device, MAX Predicate Devices Idys® ALIF ZP 3DTi, CLARIANCE SAS (K192168): primary predicate Idys® ALIF System, CLARIANCE SAS (K172083): additional predicate (materials and instruments) SYNFIX® Evolution Secured Spacer System (K150673): cage size ref… | 2017 |
| † | K150673 | SYNFIX Evolution Secured Spacer System | 2015 |
What descends from it? (3)
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 · 5 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 19 years and passes through 7 companies; a new generation was cleared every 1.1 years on median.
- 21 of the 210 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K212562 (Clariance, SA, 2021) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K192168.
How does its category compare?
All MAX devicesMAX Intervertebral Fusion Device With Bone Graft, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · MAX
29in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MAX
85in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MAX
5in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · MAX
811in 2025
MAUDE reports naming product code MAX, 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 | 7 | 86 | 0 | 12 |
| 2008 | 35 | 88 | 2 | 19 |
| 2009 | 31 | 102 | 9 | 90 |
| 2010 | 29 | 137 | 0 | 154 |
| 2011 | 49 | 98 | 3 | 201 |
| 2012 | 48 | 69 | 11 (1) | 327 |
| 2013 | 58 | 102 | 0 | 380 |
| 2014 | 58 | 115 | 3 | 366 |
| 2015 | 53 | 113 | 1 | 524 |
| 2016 | 64 | 124 | 6 | 647 |
| 2017 | 76 | 116 | 1 | 596 |
| 2018 | 64 | 114 | 4 | 616 |
| 2019 | 60 | 131 | 1 | 699 |
| 2020 | 56 | 106 | 0 | 640 |
| 2021 | 53 | 109 | 0 | 622 |
| 2022 | 41 | 95 | 1 | 618 |
| 2023 | 30 | 87 | 0 | 576 |
| 2024 | 38 | 91 | 1 | 729 |
| 2025 | 29 | 85 | 5 | 811 |
| 2026 | 18 | 95 | 0 | — |
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 (131 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 bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone to help promote fusion
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200920 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200920: 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/K200920
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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