510(k) · Cleared
ClearedWave O Cage
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Medical Technologies AG · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Jun 29, 2012 as substantially equivalent to K083626 (Advanced Medical Technology, Inc., 2009) after a 57-day review. Its family tree reaches back 1 generation to 2009. 1 later device descends from it.
- Decided
- Jun 29, 2012
- Review
- 57 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K083626 (2009). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K212050NGM WAVE PLIF CageNGMedical GmbH · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K083626 | Distractable Wave Cage | Advanced Medical Technology, Inc. | 2009 | — |
| 0 (this device) | K121330 | Wave O Cage | Advanced Medical Technologies AG | 2012 | — |
| +1 | K212050 | NGM WAVE PLIF Cage | NGMedical GmbH | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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? (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 |
|---|---|---|---|
| * | K083626 | Distractable Wave CageSummary page 1…CFR section: 21 CFR section 888.3080 Device panel: Orthopedic Legally Marketed Predicate Device: Distractable WAVE Cage - K083626 Submitter: Advanced Medical Technologies AG Kasteler Strasse 11… | 2009 |
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 |
|---|---|---|---|
| K212050 | NGM WAVE PLIF Cage | 2021 | 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?
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. 2012, 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 WAVE 0 Cage is indicated for use with autogenous bone graft in patients with degenerative disc disease (ODD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I Spondylolishesis or retrolisthesis at the involved levels. ODD 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…
Read the full statement (138 words)
The WAVE 0 Cage is indicated for use with autogenous bone graft in patients with
degenerative disc disease (ODD) at one or two contiguous levels from L2 to S1. These DDD
patients may also have up to Grade I Spondylolishesis or retrolisthesis at the involved
levels. ODD 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 an open or a
minimally invasive unilateral posterior approach. Alternatively, these implants may also be
implanted via a transforaminal approach. These implants are to be used with autogenous
bone graft. These devices 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/K121330 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121330: Wave O Cage.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121330
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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