510(k) Report

510(k) · Cleared

Cleared

Aleutian Spacer, Model K2-07-1004-01, K2-07-1005-01

K080024510(k) SpecialCleared Jan 24, 200820-day reviewClass II21 CFR 888.3060

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

K2m, Inc. · MQP Spinal Vertebral Body Replacement Device

Cleared on Jan 24, 2008 after a 20-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 663 later devices descend from it.

Decided
Jan 24, 2008
Review
20 days
Class
Class II
Product code
MQP
Recalls
None
Predicates
0

663 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2009: 1 descendant cleared2011: 4 descendants cleared2013: 9 descendants cleared2016: 16 descendants cleared2012: 6 descendants cleared2015: 16 descendants cleared2014: 12 descendants cleared2010: 2 descendants cleared2020: 61 descendants cleared2019: 45 descendants cleared2017: 38 descendants cleared2018: 47 descendants cleared2021: 58 descendants cleared2024: 81 descendants cleared2025: 64 descendants cleared2023: 81 descendants cleared2022: 66 descendants cleared2026: 56 descendants cleared20052010201520202025
  1. This deviceK080024 Aleutian Spacer, Model K2-07-1004-01, K2-07-1005-01K2m, Inc. · 2008
  2. Descendant · cites it directly · 662 of its ownK082698 Aleutian Ibf SystemK2m, Inc. · 2009
  3. Descendant · 2 generations on · 595 of its ownK101302 Aleutian Ibf SystemK2m, Inc. · 2010
  4. Descendant · cites it directly · 589 of its ownK110843 Aleutian Spacer SystemK2m, Inc. · 2011
  5. Descendant · 2 generations on · 572 of its ownK103169 AleuttianK2m, Inc. · 2011
  6. Descendant · 2 generations on · 570 of its ownK130699 Aleutian Spinal SystemK2m, Inc. · 2013

Showing 5 of 663 descendants. See all descendants

Descendants cleared per year

2009: 12010: 22011: 42012: 62013: 92014: 122015: 162016: 162017: 382018: 472019: 452020: 612021: 582022: 662023: 812024: 812025: 642026: 56
2009high 81 (2023) · low 1 (2009)2026

Most influential descendants

Showing 5 of 663 · See all
  • K082698Aleutian Ibf SystemK2m, Inc. · 2009 · cites it directly662descendants
  • K101302Aleutian Ibf SystemK2m, Inc. · 2010 · 2 generations on595descendants
  • K110843Aleutian Spacer SystemK2m, Inc. · 2011 · cites it directly589descendants
  • K103169AleuttianK2m, Inc. · 2011 · 2 generations on572descendants
  • K130699Aleutian Spinal SystemK2m, Inc. · 2013 · 2 generations on570descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K080024Aleutian Spacer, Model K2-07-1004-01, K2-07-1005-01K2m, Inc.2008—
+1K082698Aleutian Ibf SystemK2m, Inc.2009—
+2K101302Aleutian Ibf SystemK2m, Inc.2010—
+1K110843Aleutian Spacer SystemK2m, Inc.2011—
+2K103169AleuttianK2m, Inc.2011—
+2K130699Aleutian Spinal SystemK2m, Inc.2013—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201020
201140
201260
201390
2014120
2015160
2016160
2017380
2018470
2019450
2020610
2021580
2022660
2023810
2024810
2025640
2026560
FIG. 1 — Lineage of K080024, 2008–2026Source: 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.

Planning a device in MQP? 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 MQP device

  1. #1 K261810 Vertiwedge® Intraosseous Systemscore 18.1 · 22 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? (663)

See all 663

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

NumberDeviceApplicantDecidedDescendants
K082698Aleutian Ibf SystemK2m, Inc.2009662
K110843Aleutian Spacer SystemK2m, Inc.2011589

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?

  • Of its descendants, K082698 (K2m, Inc., 2009) has gone furthest, with 662 descendants of its own.

How does its category compare?

All MQP devices

MQP Spinal Vertebral Body Replacement Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · MQP

4in 2024

2007: 302008: 172009: 112010: 62011: 82012: 72013: 32014: 52015: 82017: 92018: 62019: 82020: 32022: 12023: 12024: 42026 (partial year): 3
2007high 30 (2007) · low 0 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MQP

187in 2024

2007: 107 days median2008: 47 days median2009: 115 days median2010: 174 days median2011: 237 days median2012: 82 days median2013: 90 days median2014: 125 days median2015: 126 days median2017: 97 days median2018: 152 days median2019: 93 days median2020: 103 days median2024: 187 days median2026 (partial year): 102 days median
2007high 237 (2011) · low 47 (2008)2026

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

Recalls per year · MQP

1in 2022

2007: 22009: 142010: 22011: 12012: 22020: 152022: 1
2007high 15 (2020) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MQP

168in 2025

2007: 612008: 762009: 1112010: 1662011: 1212012: 1412013: 2072014: 2162015: 2582016: 1292017: 1412018: 1302019: 1172020: 1572021: 2082022: 1372023: 712024: 982025: 168
2007high 258 (2015) · low 61 (2007)2025

MAUDE reports naming product code MQP, 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
200730107261
20081747076
20091111514111
201061742166
201182371121
20127822141
20133900207
201451250216
201581260258
20160—0129
20179970141
201861520130
20198930117
2020310315157
20210—0208
20221—1137
20231—071
20244187098
20250—0168
202631020—

More from K2m, Inc.

100 FDA decisions under this applicant name. See the company

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  • K202528Cannulated Power Driver AttachmentK2m, Inc. · 2020

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The MQP category page

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https://510kreport.com/device/K080024 · printed Nov 5, 2026

Cite this page

510(k) Report. “K080024: Aleutian Spacer, Model K2-07-1004-01, K2-07-1005-01.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K080024

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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