510(k) · Cleared
ClearedIdys™ TLIF TiVac
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 Mar 1, 2019 as substantially equivalent to K131178 (Clariance, 2013) and 1 other predicate after a 100-day review. Its family tree reaches back 13 generations to 2001. 1 later device descends from it.
- Decided
- Mar 1, 2019
- Review
- 100 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 13 generations to K003155 (2001). 70 ancestors in all, the oldest K841189 (1984). 1 later device descends from it, 1 citing it directly.
- Root · 13 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 9 generations between
- 3 generations backK071983 Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace…Aesculap Implant Systems, Inc. · 2008 · Recalled
- 2 generations backK113478 Plif CageEisertech, LLC · 2012
- 1 generation backK131178 Idys Lif CagesClariance · 2013
- This deviceK183259 Idys™ TLIF TiVacClariance, Sas · 2019
- Descendant · cites it directly · 0 of its ownK191263 Idys ALIF TiVacClariance, Sas · 2019
Show all 13 generations
- Root · 13 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 12 generations backK012254 VBROsteotech, Inc. · 2001
- 11 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 10 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 9 generations backK031780 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 8 generations backK040731 Stryker Spine Vertebral SpacerStryker Spine · 2004
- 7 generations backK042571 Stryker Spine Avs TL Peek SpacerStryker Spine · 2005
- 6 generations backK050624 Stryker Spine Avs PL Peek SpacerStryker Spine · 2005
- 5 generations backK051205 Stryker Spine Avs Asl Peek SpacerStryker Spine · 2005
- 4 generations backK060762 Aesculap Peek Vertebral Body Replacement SystemAesculap, Inc. · 2006
- 3 generations backK071983 Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace…Aesculap Implant Systems, Inc. · 2008 · Recalled
- 2 generations backK113478 Plif CageEisertech, LLC · 2012
- 1 generation backK131178 Idys Lif CagesClariance · 2013
- This deviceK183259 Idys™ TLIF TiVacClariance, Sas · 2019
Most influential descendants
Showing 1 of 1 · See all- K191263Idys ALIF TiVacClariance, Sas · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −12 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −11 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −10 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −9 | K031780 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −8 | K040731 | Stryker Spine Vertebral Spacer | Stryker Spine | 2004 | — |
| −7 | K042571 | Stryker Spine Avs TL Peek Spacer | Stryker Spine | 2005 | — |
| −6 | K050624 | Stryker Spine Avs PL Peek Spacer | Stryker Spine | 2005 | — |
| −5 | K051205 | Stryker Spine Avs Asl Peek Spacer | Stryker Spine | 2005 | — |
| −4 | K060762 | Aesculap Peek Vertebral Body Replacement System | Aesculap, Inc. | 2006 | — |
| −3 | K071983 | Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace… | Aesculap Implant Systems, Inc. | 2008 | 1 |
| −2 | K113478 | Plif Cage | Eisertech, LLC | 2012 | — |
| −1 | K131178 | Idys Lif Cages | Clariance | 2013 | — |
| 0 (this device) | K183259 | Idys™ TLIF TiVac | Clariance, Sas | 2019 | — |
| +1 | K191263 | Idys ALIF TiVac | Clariance, Sas | 2019 | — |
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 | 7 | 0 |
| 2002 | 4 | 0 |
| 2003 | 7 | 0 |
| 2004 | 11 | 0 |
| 2005 | 6 | 0 |
| 2007 | 6 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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.
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? (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…vice with Bone Graft Classification Name Class II, 21 CFR §888.3080 - Intervertebral body fusion device, MAX Predicate Devices Idys™ TLIF Cage, CLARIANCE SAS (K131178): primary predicate Lucent® Ti-BOND®, Spinal Elements (K150061): additional predicate (Titanium coating) Purpose of the… | 2013 |
| * | K150061 | Lucent; Lucent Ti-Bond SystemsSummary page 4…Intervertebral body fusion device, MAX Predicate Devices Idys™ TLIF Cage, CLARIANCE SAS (K131178): primary predicate Lucent® Ti-BOND®, Spinal Elements (K150061): additional predicate (Titanium coating) Purpose of the Traditional 510(k) notice The Idys™ TLIF TiVac is a modificatio… | 2015 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K191263 | Idys ALIF TiVac | 2019 | 0 |
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 18 years and passes through 8 companies; a new generation was cleared every 10 months on median.
- 8 of the 70 ancestors have a recall of any class.
- Of its descendants, K191263 (Clariance, Sas, 2019) has gone furthest, with 0 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. 2019, 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 TiVac cages are indicated for use with autologous 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 devices are intended for
intervertebral body fusion, and are intended to be used with supplemental fixation instrumentation, which
has been cleared by FDA for use in the lumbar spine.
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/K183259 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183259: Idys™ TLIF TiVac.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183259
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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