510(k) · Cleared
ClearedDistractable Wave Cage
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Medical Technology, Inc. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Oct 19, 2009 after a 315-day review. The FDA summary names no predicate by number. 1 of the 661 devices in its family, counting itself, has a Class I recall. 660 later devices descend from it.
- Decided
- Oct 19, 2009
- Review
- 315 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 0
660 later devices descend from it, 9 citing it directly. 1 of the 661 devices in this family, counting this one, has a Class I recall.
- This deviceK083626 Distractable Wave CageAdvanced Medical Technology, Inc. · 2009
- Descendant · cites it directly · 537 of its ownK112316 4-Web Alif Spinal Truss System (STS)4-Web, Inc. · 2011 · Recalled
- Descendant · 2 generations on · 459 of its ownK150481 Cascadia Interbody SystemK2m, Inc. · 2015 · Recalled
- Descendant · cites it directly · 343 of its ownK103111 Forza Spacer SystemOrthofix, Inc. · 2011 · Recalled
- Descendant · 3 generations on · 315 of its ownK160125 Cascadia Interbody SystemK2m · 2016
- Descendant · 3 generations on · 276 of its ownK163230 NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated · 2017
Showing 5 of 660 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub4 generations on · 2021
Most influential descendants
Showing 5 of 660 · See all- K1123164-Web Alif Spinal Truss System (STS)4-Web, Inc. · 2011 · cites it directly537descendants
- K150481Cascadia Interbody SystemK2m, Inc. · 2015 · 2 generations on459descendants
- K103111Forza Spacer SystemOrthofix, Inc. · 2011 · cites it directly343descendants
- K160125Cascadia Interbody SystemK2m · 2016 · 3 generations on315descendants
- K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated · 2017 · 3 generations on276descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K083626 | Distractable Wave Cage | Advanced Medical Technology, Inc. | 2009 | — |
| +1 | K112316 | 4-Web Alif Spinal Truss System (STS) | 4-Web, Inc. | 2011 | 1 |
| +2 | K150481 | Cascadia Interbody System | K2m, Inc. | 2015 | 3 |
| +1 | K103111 | Forza Spacer System | Orthofix, Inc. | 2011 | 1 |
| +3 | K160125 | Cascadia Interbody System | K2m | 2016 | — |
| +3 | K163230 | NuVasive Modulus XLIF Interbody System | Nu Vasive, Incorporated | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 4 | 0 |
| 2014 | 5 | 0 |
| 2015 | 12 | 0 |
| 2016 | 17 | 0 |
| 2017 | 39 | 0 |
| 2018 | 36 | 0 |
| 2019 | 49 | 0 |
| 2020 | 64 | 0 |
| 2021 | 61 | 1 |
| 2022 | 65 | 0 |
| 2023 | 82 | 0 |
| 2024 | 87 | 0 |
| 2025 | 71 | 0 |
| 2026 | 64 | 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? (660)
See all 6609 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K112316 | 4-Web Alif Spinal Truss System (STS) | 2011 | 537 |
| K103111 | Forza Spacer System | 2011 | 343 |
| K142559 | ELEVATE Spinal System | 2015 | 130 |
| K123461 | Staxx (R) IB System | 2013 | 25 |
| K141980 | Leva (TM) Spacer System | 2015 | 9 |
| K142634 | Biomet Spine Fusion System | 2015 | 5 |
| K121330 | Wave O Cage | 2012 | 1 |
| K212050 | NGM WAVE PLIF Cage | 2021 | 0 |
| K203327 | VERTACONNECT TLIF Cage | 2021 | 0 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
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 · 4 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K112316 (4-Web, Inc., 2011) has gone furthest, with 537 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. 2009, 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 distractable WAVE PLIF 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. Degenerative disc disease is defined .as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved…
Read the full statement (118 words)
The distractable WAVE PLIF 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. Degenerative disc disease is defined .as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). Distractable WAVE PLIF Cage implants are to be used with autogenous bone graft and implanted via an open posterior approach. The distractable WAVE PLIF Cages are to be used with supplemental fixation. Patients should have at least (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/K083626 · printed Nov 5, 2026
Cite this page
510(k) Report. “K083626: Distractable Wave Cage.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K083626
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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