510(k) · Cleared
ClearedIdys™ TLIF 3DTi Cages
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 Dec 15, 2017 as substantially equivalent to K131178 (Clariance, 2013) and 1 other predicate after a 123-day review. Its family tree reaches back 15 generations to 1984. 1 of the 123 devices in its family, counting itself, has a Class I recall. 6 later devices descend from it.
- Decided
- Dec 15, 2017
- Review
- 123 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 15 generations to K841189 (1984). 116 ancestors in all. 6 later devices descend from it, 1 citing it directly. 1 of the 123 devices in this family, counting this one, has a Class I recall.
- Root · 15 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 11 generations between
- 3 generations backK130699 Aleutian Spinal SystemK2m, Inc. · 2013
- 2 generations backK133614 Aleutian Ibf SystemK2m, Inc. · 2014
- 1 generation backK150481 Cascadia Interbody SystemK2m, Inc. · 2015 · Recalled
- This deviceK172465 Idys™ TLIF 3DTi CagesClariance, Sas · 2017
- Descendant · cites it directly · 5 of its ownK192168 Idys ALIF ZP 3DTiClariance, Sas · 2019
- Descendant · 2 generations on · 3 of its ownK200920 Idys ALIF ZP 3DTiClariance, Sas · 2020
- Descendant · 3 generations on · 1 of its ownK212562 Idys-C ZP 3DTiClariance, SA · 2021
- Descendant · 4 generations on · 0 of its ownK240715 Idys® C ZP 3DTiClariance · 2024
- Descendant · 2 generations on · 0 of its ownK200919 Idys ALIF 3DTiClariance · 2021
Show all 15 generations
- Root · 15 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 14 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 13 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 12 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 11 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 10 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 9 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 8 generations backK051454 Aleutian Spacer SystemK2m, LLC · 2005
- 7 generations backK063399 Aleutian Spacer SystemK2m, Inc. · 2007
- 6 generations backK082698 Aleutian Ibf SystemK2m, Inc. · 2009
- 5 generations backK101302 Aleutian Ibf SystemK2m, Inc. · 2010
- 4 generations backK103169 AleuttianK2m, Inc. · 2011
- 3 generations backK130699 Aleutian Spinal SystemK2m, Inc. · 2013
- 2 generations backK133614 Aleutian Ibf SystemK2m, Inc. · 2014
- 1 generation backK150481 Cascadia Interbody SystemK2m, Inc. · 2015 · Recalled
- This deviceK172465 Idys™ TLIF 3DTi CagesClariance, Sas · 2017
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K073202 Ardis Spacer3 generations back · 2008
Most influential descendants
Showing 5 of 6 · See all- K192168Idys ALIF ZP 3DTiClariance, Sas · 2019 · cites it directly5descendants
- K200920Idys ALIF ZP 3DTiClariance, Sas · 2020 · 2 generations on3descendants
- K212562Idys-C ZP 3DTiClariance, SA · 2021 · 3 generations on1descendant
- K240715Idys® C ZP 3DTiClariance · 2024 · 4 generations on0descendants
- K200919Idys ALIF 3DTiClariance · 2021 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −14 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −13 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −12 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −11 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −10 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −9 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −8 | K051454 | Aleutian Spacer System | K2m, LLC | 2005 | — |
| −7 | K063399 | Aleutian Spacer System | K2m, Inc. | 2007 | — |
| −6 | K082698 | Aleutian Ibf System | K2m, Inc. | 2009 | — |
| −5 | K101302 | Aleutian Ibf System | K2m, Inc. | 2010 | — |
| −4 | K103169 | Aleuttian | K2m, Inc. | 2011 | — |
| −3 | K130699 | Aleutian Spinal System | K2m, Inc. | 2013 | — |
| −2 | K133614 | Aleutian Ibf System | K2m, Inc. | 2014 | — |
| −1 | K150481 | Cascadia Interbody System | K2m, Inc. | 2015 | 3 |
| 0 (this device) | K172465 | Idys™ TLIF 3DTi Cages | Clariance, Sas | 2017 | — |
| +1 | K192168 | Idys ALIF ZP 3DTi | Clariance, Sas | 2019 | — |
| +2 | K200920 | Idys ALIF ZP 3DTi | Clariance, Sas | 2020 | — |
| +3 | K212562 | Idys-C ZP 3DTi | Clariance, SA | 2021 | — |
| +4 | K240715 | Idys® C ZP 3DTi | Clariance | 2024 | — |
| +2 | K200919 | Idys ALIF 3DTi | Clariance | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 9 | 0 |
| 2002 | 8 | 0 |
| 2003 | 11 | 0 |
| 2004 | 13 | 0 |
| 2005 | 10 | 0 |
| 2006 | 1 | 0 |
| 2007 | 10 | 0 |
| 2008 | 15 | 1 |
| 2009 | 5 | 0 |
| 2010 | 2 | 0 |
| 2011 | 5 | 0 |
| 2012 | 4 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 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 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 |
|---|---|---|---|
| * | K131178 | Idys Lif CagesSummary page 4…e Lumbar Intervertebral Body Fusion Device Classification Name 888.3080 - Intervertebral body fusion Product Code MAX Predicate Devices CLARIANCE, Idys TLIF Cage, K131178 (primary) K2M, CASCADIA TL, K150481 (additional) Intended Use / Indications for Use The Idys™ TLIF 3DTi cages are indic… | 2013 |
| * | K150481 | Cascadia Interbody SystemSummary page 4…Device Classification Name 888.3080 - Intervertebral body fusion Product Code MAX Predicate Devices CLARIANCE, Idys TLIF Cage, K131178 (primary) K2M, CASCADIA TL, K150481 (additional) Intended Use / Indications for Use The Idys™ TLIF 3DTi cages are indicated for use with autogenous bone gra… | 2015 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K192168 | Idys ALIF ZP 3DTi | 2019 | 5 |
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 · 3 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 33 years and passes through 9 companies; a new generation was cleared every 1.4 years on median.
- 17 of the 116 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K192168 (Clariance, Sas, 2019) has gone furthest, with 5 descendants of its own.
- 4 other devices also cite its predicate K131178.
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. 2017, 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™ TLIF 3DTi cages are indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain 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 implants may be implanted via a posterior and/or transforaminal approach. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared for use in the lumbar spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172465 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172465: Idys™ TLIF 3DTi Cages.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172465
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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