510(k) · Cleared
ClearedIdys Lif Cages
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Clariance · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Oct 10, 2013 as substantially equivalent to K113478 (Eisertech, LLC, 2012) and 2 other predicates after a 168-day review. Its family tree reaches back 12 generations to 2001. 11 later devices descend from it.
- Decided
- Oct 10, 2013
- Review
- 168 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 12 generations to K003155 (2001). 62 ancestors in all, the oldest K841189 (1984). 11 later devices descend from it, 5 citing it directly.
- Root · 12 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 8 generations between
- 3 generations backK060762 Aesculap Peek Vertebral Body Replacement SystemAesculap, Inc. · 2006
- 2 generations backK071983 Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace…Aesculap Implant Systems, Inc. · 2008 · Recalled
- 1 generation backK113478 Plif CageEisertech, LLC · 2012
- This deviceK131178 Idys Lif CagesClariance · 2013
- Descendant · cites it directly · 7 of its ownK172083 Idys™ ALIF SystemClariance, Sas · 2017
- Descendant · cites it directly · 6 of its ownK172465 Idys™ TLIF 3DTi CagesClariance, Sas · 2017
- Descendant · 2 generations on · 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
Show all 12 generations
- Root · 12 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 11 generations backK012254 VBROsteotech, Inc. · 2001
- 10 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 9 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 8 generations backK031780 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 7 generations backK040731 Stryker Spine Vertebral SpacerStryker Spine · 2004
- 6 generations backK042571 Stryker Spine Avs TL Peek SpacerStryker Spine · 2005
- 5 generations backK050624 Stryker Spine Avs PL Peek SpacerStryker Spine · 2005
- 4 generations backK051205 Stryker Spine Avs Asl Peek SpacerStryker Spine · 2005
- 3 generations backK060762 Aesculap Peek Vertebral Body Replacement SystemAesculap, Inc. · 2006
- 2 generations backK071983 Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace…Aesculap Implant Systems, Inc. · 2008 · Recalled
- 1 generation backK113478 Plif CageEisertech, LLC · 2012
- This deviceK131178 Idys Lif CagesClariance · 2013
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K172083Idys™ ALIF SystemClariance, Sas · 2017 · cites it directly7descendants
- K172465Idys™ TLIF 3DTi CagesClariance, Sas · 2017 · cites it directly6descendants
- K192168Idys ALIF ZP 3DTiClariance, Sas · 2019 · 2 generations on5descendants
- K200920Idys ALIF ZP 3DTiClariance, Sas · 2020 · 2 generations on3descendants
- K212562Idys-C ZP 3DTiClariance, SA · 2021 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −11 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −10 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −9 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −8 | K031780 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −7 | K040731 | Stryker Spine Vertebral Spacer | Stryker Spine | 2004 | — |
| −6 | K042571 | Stryker Spine Avs TL Peek Spacer | Stryker Spine | 2005 | — |
| −5 | K050624 | Stryker Spine Avs PL Peek Spacer | Stryker Spine | 2005 | — |
| −4 | K051205 | Stryker Spine Avs Asl Peek Spacer | Stryker Spine | 2005 | — |
| −3 | K060762 | Aesculap Peek Vertebral Body Replacement System | Aesculap, Inc. | 2006 | — |
| −2 | K071983 | Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace… | Aesculap Implant Systems, Inc. | 2008 | 1 |
| −1 | K113478 | Plif Cage | Eisertech, LLC | 2012 | — |
| 0 (this device) | K131178 | Idys Lif Cages | Clariance | 2013 | — |
| +1 | K172083 | Idys™ ALIF System | Clariance, Sas | 2017 | — |
| +1 | K172465 | Idys™ TLIF 3DTi Cages | Clariance, Sas | 2017 | — |
| +2 | 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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1996 | 2 | 0 |
| 1999 | 3 | 0 |
| 2000 | 1 | 0 |
| 2001 | 6 | 0 |
| 2002 | 4 | 0 |
| 2003 | 7 | 0 |
| 2004 | 11 | 0 |
| 2005 | 6 | 0 |
| 2007 | 6 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 2 | 0 |
| 2019 | 3 | 0 |
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2024 | 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 MAX? 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? (3)
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 |
|---|---|---|---|
| * | K113478 | Plif CageSummary page 2…ldysn' LIF, Cages PLIF Cage Aleutian 1SIF System Synthes OPAL (K1 13478) (K082698) Spacer _______________________________________(K0727… | 2012 |
| * | K082698 | Aleutian Ibf SystemSummary page 2…PLIF Cage Aleutian 1SIF System Synthes OPAL (K1 13478) (K082698) Spacer _______________________________________(K072791) Anatomical… | 2009 |
| * | K072791 | Oracle Spacer, Opal SpacerSummary page 2…(K1 13478) (K082698) Spacer _______________________________________(K072791) Anatomical L.2 to S1 L2 to Si L2 to Si [L2 to S1 sites… | 2007 |
What descends from it? (11)
See all 115 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 12 years and passes through 7 companies; a new generation was cleared every 10 months on median.
- 7 of the 62 ancestors have a recall of any class.
- Of its descendants, K172083 (Clariance, Sas, 2017) has gone furthest, with 7 descendants of its own.
- 7 other devices also cite its predicate K113478.
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. 2013, 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 ldys1U LIF Cages are indicated for use with autologous bane graft in patients with degenerative disc disease (DOD) at one or two levels from L2 to Si. These DOD patients may also have up to Grade 1 Spondylollsthesis or retrolisthesis at the involved levels. ODD is defined as discagenic 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 devices are intended for intervertebral body fusion, and are Intended to be used with supplemental fixation instrumentation which has been cleared by the FDA for use in the lumbar spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131178 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131178: Idys Lif Cages.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131178
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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