510(k) · Cleared
Recalled · Class II · 2017L-Varlock
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kiscomedica S.A. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Jun 30, 2008 after a 124-day review. The FDA summary names no predicate by number. 1 of the 959 devices in its family, counting itself, has a Class I recall. 958 later devices descend from it. It has been recalled once.
- Decided
- Jun 30, 2008
- Review
- 124 days
- Class
- Class II
- Product code
- MAX
- Recalls
- 1
- Predicates
- 0
958 later devices descend from it, 13 citing it directly. 1 of the 959 devices in this family, counting this one, has a Class I recall.
- This deviceK080537 L-VarlockKiscomedica S.A. · 2008
- Descendant · cites it directly · 869 of its ownK102293 Caliber SpacerGlobus Medical, Inc. · 2011
- Descendant · cites it directly · 762 of its ownK111512 Bonebac T-Plif Intervertebral Body Fusion Device SystemThompson Mis, Inc. · 2011
- Descendant · 2 generations on · 761 of its ownK120368 Capstone Control Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
- Descendant · 3 generations on · 723 of its ownK121760 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
- Descendant · 2 generations on · 718 of its ownK113465 Acculif TL CageCoalign Innovations, Inc. · 2011
Showing 5 of 958 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub3 generations on · 2021
Most influential descendants
Showing 5 of 958 · See all- K102293Caliber SpacerGlobus Medical, Inc. · 2011 · cites it directly869descendants
- K111512Bonebac T-Plif Intervertebral Body Fusion Device SystemThompson Mis, Inc. · 2011 · cites it directly762descendants
- K120368Capstone Control Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012 · 2 generations on761descendants
- K121760Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012 · 3 generations on723descendants
- K113465Acculif TL CageCoalign Innovations, Inc. · 2011 · 2 generations on718descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K080537 | L-Varlock | Kiscomedica S.A. | 2008 | — |
| +1 | K102293 | Caliber Spacer | Globus Medical, Inc. | 2011 | — |
| +1 | K111512 | Bonebac T-Plif Intervertebral Body Fusion Device System | Thompson Mis, Inc. | 2011 | — |
| +2 | K120368 | Capstone Control Spinal System | Medtronic Sofamor Danek USA, Inc. | 2012 | — |
| +3 | K121760 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2012 | — |
| +2 | K113465 | Acculif TL Cage | Coalign Innovations, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 5 | 0 |
| 2012 | 7 | 0 |
| 2013 | 17 | 0 |
| 2014 | 24 | 0 |
| 2015 | 29 | 0 |
| 2016 | 51 | 0 |
| 2017 | 75 | 0 |
| 2018 | 72 | 0 |
| 2019 | 80 | 0 |
| 2020 | 92 | 0 |
| 2021 | 77 | 1 |
| 2022 | 80 | 0 |
| 2023 | 96 | 0 |
| 2024 | 97 | 0 |
| 2025 | 81 | 0 |
| 2026 | 74 | 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?
The FDA summary names no predicate by number.
What descends from it? (958)
See all 95813 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102293 | Caliber Spacer | 2011 | 869 |
| K111512 | Bonebac T-Plif Intervertebral Body Fusion Device System | 2011 | 762 |
| K123231 | Caliber Spacers | 2013 | 657 |
| K133813 | Flxfit Intervertebral Body Fusion Device | 2014 | 137 |
| K113527 | Opticage Interbody Fusion Device | 2012 | 103 |
| K153400 | ProLift Expandable System | 2016 | 72 |
| K171519 | FLXfit™ | 2017 | 71 |
| K100820 | Wenzel Spine Varilift Interbody Fusion System | 2010 | 16 |
| K110442 | Nanovis Intervertebral Body Fusion System | 2011 | 10 |
| K153786 | Prow Fusion-V | 2016 | 6 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 11, 2017 | Class II | Z-1461-2017 | Process control | Firm received a complaint of the tip holder breaking during use. |
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.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 3 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K102293 (Globus Medical, Inc., 2011) has gone furthest, with 869 descendants of its own.
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. 2008, 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 L-Varlock Lumbar Cage is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). L-Varlock Lumbar implants are to be used…
Read the full statement (110 words)
The L-Varlock Lumbar Cage is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s).
L-Varlock Lumbar implants are to be used with autogenous bone graft and implanted via an open posterior approach. L-Varlock Lumbar implant is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080537 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080537: L-Varlock.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080537
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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