510(k) Report

510(k) · Cleared

Cleared

Wave D Cage

K121333510(k) TraditionalCleared Jun 29, 201257-day reviewClass II21 CFR 888.3080

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Advanced Medical Technologies AG · MAX Intervertebral Fusion Device With Bone Graft, Lumbar

Cleared on Jun 29, 2012 after a 57-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 160 devices in its family, counting itself, has a Class I recall. 159 later devices descend from it.

Decided
Jun 29, 2012
Review
57 days
Class
Class II
Product code
MAX
Recalls
None
Predicates
0

159 later devices descend from it, 3 citing it directly. 1 of the 160 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 2015: 1 descendant cleared2021: 13 descendants cleared, 1 with a Class I recall12017: 3 descendants cleared2020: 7 descendants cleared2022: 14 descendants cleared2024: 35 descendants cleared2019: 6 descendants cleared2026: 33 descendants cleared2023: 14 descendants cleared2025: 33 descendants cleared2010201520202025
  1. This deviceK121333 Wave D CageAdvanced Medical Technologies AG · 2012
  2. Descendant · cites it directly · 130 of its ownK142559 ELEVATE Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2015
  3. Descendant · cites it directly · 109 of its ownK171689 ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti…Medtronic Sofamor Danek USA, Inc. · 2017
  4. Descendant · 2 generations on · 108 of its ownK190959 ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti…Medtronic Sofamor Danek USA, Inc. · 2019
  5. Descendant · 2 generations on · 103 of its ownK163581 Navigated ELEVATE Inserter, Navigated Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc. · 2017
  6. Descendant · 3 generations on · 102 of its ownK192018 Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS…Titan Spine, Inc. · 2019 · Recalled

Showing 5 of 159 descendants. See all descendants

Descendants cleared per year

2015: 12017: 32019: 62020: 72021: 132022: 142023: 142024: 352025: 332026: 33
2015high 35 (2024) · low 0 (2016)2026

Class I recalls in this family

  • K211616 ExcelsiusHub4 generations on · 2021

Most influential descendants

Showing 5 of 159 · See all
  • K142559ELEVATE Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2015 · cites it directly130descendants
  • K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc. · 2017 · cites it directly109descendants
  • K190959ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc. · 2019 · 2 generations on108descendants
  • K163581Navigated ELEVATE Inserter, Navigated Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc. · 2017 · 2 generations on103descendants
  • K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc. · 2019 · 3 generations on102descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K121333Wave D CageAdvanced Medical Technologies AG2012—
+1K142559ELEVATE Spinal SystemMedtronic Sofamor Danek USA, Inc.2015—
+1K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal…Medtronic Sofamor Danek USA, Inc.2017—
+2K190959ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal…Medtronic Sofamor Danek USA, Inc.2019—
+2K163581Navigated ELEVATE Inserter, Navigated Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.2017—
+3K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS…Titan Spine, Inc.20194

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201510
201730
201960
202070
2021131
2022140
2023140
2024350
2025330
2026330
FIG. 1 — Lineage of K121333, 2012–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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. #1 K203714 NuVasive Thoracolumbar Interbody Systems…score 102.5 · 24 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (159)

See all 159

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K142559ELEVATE Spinal SystemMedtronic Sofamor Danek USA, Inc.2015130
K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2017109
K212050NGM WAVE PLIF CageNGMedical GmbH20210

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, K142559 (Medtronic Sofamor Danek USA, Inc., 2015) has gone furthest, with 130 descendants of its own.

How does its category compare?

All MAX devices

MAX 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

2007: 72008: 352009: 312010: 292011: 492012: 482013: 582014: 582015: 532016: 642017: 762018: 642019: 602020: 562021: 532022: 412023: 302024: 382025: 292026 (partial year): 18
2007high 76 (2017) · low 7 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MAX

85in 2025

2007: 86 days median2008: 88 days median2009: 102 days median2010: 137 days median2011: 98 days median2012: 69 days median2013: 102 days median2014: 115 days median2015: 113 days median2016: 124 days median2017: 116 days median2018: 114 days median2019: 131 days median2020: 106 days median2021: 109 days median2022: 95 days median2023: 87 days median2024: 91 days median2025: 85 days median2026 (partial year): 95 days median
2007high 137 (2010) · low 69 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MAX

5in 2025

2008: 22009: 92011: 32012: 11, 1 Class I2014: 32015: 12016: 62017: 12018: 42019: 12022: 12024: 12025: 5
2007high 11 (2012) · low 0 (2007)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · MAX

811in 2025

2007: 122008: 192009: 902010: 1542011: 2012012: 3272013: 3802014: 3662015: 5242016: 6472017: 5962018: 6162019: 6992020: 6402021: 6222022: 6182023: 5762024: 7292025: 811
2007high 811 (2025) · low 12 (2007)2025

MAUDE reports naming product code MAX, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007786012
20083588219
200931102990
2010291370154
201149983201
2012486911 (1)327
2013581020380
2014581153366
2015531131524
2016641246647
2017761161596
2018641144616
2019601311699
2020561060640
2021531090622
202241951618
202330870576
202438911729
202529855811
202618950—

More from Advanced Medical Technologies AG

8 FDA decisions under this applicant name. See the company

  • K121332Loop CageAdvanced Medical Technologies AG · 2012
  • K121330Wave O CageAdvanced Medical Technologies AG · 2012
  • K121288Fuse CageAdvanced Medical Technologies AG · 2012
  • K100945Fuse Plif CafeAdvanced Medical Technologies AG · 2011
  • K080401Shell Cage, Wave Cage, Loop CageAdvanced Medical Technologies AG · 2008

Recent decisions in MAX

The MAX category page

  • K262646Calibrate MAX System; Calibrate NanoTec MAX System; Calibrate CCX Interbody System; Calibrate NanoTec CCX…Alphatec Spine, Inc. · 2026
  • K261049Scala® TLSpineart SA · 2026
  • K261430TruLift Expandable SystemLife Spine, Inc. · 2026
  • K253011Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc. · 2026
  • K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2026

https://510kreport.com/device/K121333 · printed Nov 6, 2026

Cite this page

510(k) Report. “K121333: Wave D Cage.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121333

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026