510(k) · Cleared
ClearedEndoLIF Delta-Cage and DoubleWedge-Cage
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Joimax GmbH · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Sep 1, 2021 as substantially equivalent to K151143 (Joimax GmbH, 2015) after a 335-day review. Its family tree reaches back 1 generation to 2015.
- Decided
- Sep 1, 2021
- Review
- 335 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K151143 (2015). No later device cites it as a predicate yet.
- Root · 1 generation backK151143 EndoLIF On-CageJoimax GmbH · 2015
- This deviceK203014 EndoLIF Delta-Cage and DoubleWedge-CageJoimax GmbH · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K151143 | EndoLIF On-Cage | Joimax GmbH | 2015 | — |
| 0 (this device) | K203014 | EndoLIF Delta-Cage and DoubleWedge-Cage | Joimax GmbH | 2021 | — |
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? (1)
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 |
|---|---|---|---|
| * | K151143 | EndoLIF On-CageSummary page 4…e: lumbar intervertebral body fusion device Regulatory Class: 2 Product Code: MAX III. PREDICATE DEVICE EndoLIF® On-Cage (K151143) This predicate has not been subject to a design-related recall IV. DEVICE DESCRIPTION The E… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
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. 2021, 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 EndoLIF® Delta-Cage and DoubleWedge-Cage are intended 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. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These patients may also have up to Grade I spondylolisthesis at the involved…
Read the full statement (133 words)
The EndoLIF® Delta-Cage and DoubleWedge-Cage are intended 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. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients may have had previous non-fusion spinal surgery at the involved spinal level(s). EndoLIF® Delta-Cage and DoubleWedge-Cage are to be used with autogeneous bone and implanted via a posterior or posteriolateral approach. The EndoLIF® Delta-Cage and DoubleWedge-Cage are to be used with supplemental FDA cleared fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an EndoLIF® cage.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K203014 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203014: EndoLIF Delta-Cage and DoubleWedge-Cage.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203014
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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