510(k) · Cleared
ClearedShell Cage, Wave Cage, Loop 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 May 9, 2008 as substantially equivalent to P980048 (Sulzer Spine-Tech, 2001) and 2 other predicates after an 85-day review. Its family tree reaches back 9 generations to 1984. 1 of the 867 devices in its family, counting itself, has a Class I recall. 840 later devices descend from it.
- Decided
- May 9, 2008
- Review
- 85 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K841189 (1984). 26 ancestors in all. 840 later devices descend from it, 7 citing it directly. 1 of the 867 devices in this family, counting this one, has a Class I recall.
- Root · 9 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 5 generations between
- 3 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 2 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 1 generation backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- This deviceK080401 Shell Cage, Wave Cage, Loop CageAdvanced Medical Technologies AG · 2008
- Descendant · cites it directly · 643 of its ownK082801 Phantom Plus Cage SystemUs Spine · 2008
- Descendant · cites it directly · 463 of its ownK100945 Fuse Plif CafeAdvanced Medical Technologies AG · 2011
- Descendant · 2 generations on · 459 of its ownK150481 Cascadia Interbody SystemK2m, Inc. · 2015 · Recalled
- Descendant · 2 generations on · 455 of its ownK100889 Endoskeleton TCTitan Spine, LLC · 2010
- Descendant · 2 generations on · 393 of its ownK093093 Small Plateau Spacer SystemLife Spine · 2010
Show all 9 generations
- Root · 9 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 8 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 7 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 6 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 5 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 4 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 3 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 2 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 1 generation backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- This deviceK080401 Shell Cage, Wave Cage, Loop CageAdvanced Medical Technologies AG · 2008
Showing 5 of 840 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub8 generations on · 2021
Most influential descendants
Showing 5 of 840 · See all- K082801Phantom Plus Cage SystemUs Spine · 2008 · cites it directly643descendants
- K100945Fuse Plif CafeAdvanced Medical Technologies AG · 2011 · cites it directly463descendants
- K150481Cascadia Interbody SystemK2m, Inc. · 2015 · 2 generations on459descendants
- K100889Endoskeleton TCTitan Spine, LLC · 2010 · 2 generations on455descendants
- K093093Small Plateau Spacer SystemLife Spine · 2010 · 2 generations on393descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −8 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −7 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −6 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −5 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −4 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −3 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −2 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −1 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| 0 (this device) | K080401 | Shell Cage, Wave Cage, Loop Cage | Advanced Medical Technologies AG | 2008 | — |
| +1 | K082801 | Phantom Plus Cage System | Us Spine | 2008 | — |
| +1 | K100945 | Fuse Plif Cafe | Advanced Medical Technologies AG | 2011 | — |
| +2 | K150481 | Cascadia Interbody System | K2m, Inc. | 2015 | 3 |
| +2 | K100889 | Endoskeleton TC | Titan Spine, LLC | 2010 | — |
| +2 | K093093 | Small Plateau Spacer System | Life Spine | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 4 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 4 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 9 | 0 |
| 2012 | 8 | 0 |
| 2013 | 6 | 0 |
| 2014 | 15 | 0 |
| 2015 | 18 | 0 |
| 2016 | 36 | 0 |
| 2017 | 58 | 0 |
| 2018 | 56 | 0 |
| 2019 | 71 | 0 |
| 2020 | 81 | 0 |
| 2021 | 72 | 1 |
| 2022 | 72 | 0 |
| 2023 | 91 | 0 |
| 2024 | 95 | 0 |
| 2025 | 76 | 0 |
| 2026 | 72 | 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? (3)
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 |
|---|---|---|---|
| * | P980048 | Bak/Cervical (Bak/C) Interbody Fusion SystemSummary page 1…Class II 3. Predicate or legally marketed devices which are substantially equivalent: : BAK/C Vista Interbody Fusion - peek-optima ItI, Zimmer Spine, Inc (P980048 S003) * BRANTIGEN I/F CAGE, DePuy Spine Inc, (P960025) * PARAMOUNT INTERVERTEBRAL BODY FUSION DEVICE (K07… | 2001 |
| * | P960025 | Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle ScrewsSummary page 1…ubstantially equivalent: : BAK/C Vista Interbody Fusion - peek-optima ItI, Zimmer Spine, Inc (P980048 S003) * BRANTIGEN I/F CAGE, DePuy Spine Inc, (P960025) * PARAMOUNT INTERVERTEBRAL BODY FUSION DEVICE (K072120) 4. Description of the device: The SHELL was espe… | 1999 |
| * | K072120 | Paramount Intervertebral Body Fusion DeviceSummary page 1…peek-optima ItI, Zimmer Spine, Inc (P980048 S003) * BRANTIGEN I/F CAGE, DePuy Spine Inc, (P960025) * PARAMOUNT INTERVERTEBRAL BODY FUSION DEVICE (K072120) 4. Description of the device: The SHELL was especially adapted to the local anatomy in order to secure the surgical… | 2007 |
What descends from it? (840)
See all 8407 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082801 | Phantom Plus Cage System | 2008 | 643 |
| K100945 | Fuse Plif Cafe | 2011 | 463 |
| K110650 | Zyston Arc Interbody Spacer | 2011 | 177 |
| K120840 | Lexus Cervical Intervertebral Body Fusion Cage System | 2012 | 14 |
| K110442 | Nanovis Intervertebral Body Fusion System | 2011 | 10 |
| K130274 | Biolign Acif Systems, Biolign Stacc Acif System, Biolign Tlif System | 2013 | 9 |
| K121569 | Matisse Anterior Cervical Interbody Fusion Cage System | 2012 | 3 |
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 · 8 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 24 years and passes through 8 companies; a new generation was cleared every 1.0 years on median.
- 2 of the 26 ancestors have a recall of any class.
- Of its descendants, K082801 (Us Spine, 2008) has gone furthest, with 643 descendants of its own.
- 53 other devices also cite its predicate P980048.
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 WAVE Cage is indicated for intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level. WAVE implants are to be used with autogenous bone graft and…
Read the full statement (314 words)
The WAVE Cage is indicated for intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level. WAVE implants are to be used with autogenous bone graft and implanted via an open posterior approach. The WAVE Cage 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.
The LOOP Cage is indicated for intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level. LOOP implants are to be used with autogenous bone graft and implanted via an open posterior approach. The LOOP Cage 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.
SHELL Cages are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. SHELL Cages are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at the C3 to C7 disc levels using autograft bone. SHELL Cages are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080401 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080401: Shell Cage, Wave Cage, Loop Cage.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080401
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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