510(k) Report

510(k) · Cleared

Cleared

Aleutian Spacer System

K051454510(k) TraditionalCleared Jul 27, 200555-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, LLC · MQP Spinal Vertebral Body Replacement Device

Cleared on Jul 27, 2005 as substantially equivalent to K043405 (Nuvasive, Inc., 2005) and 2 other predicates after a 55-day review. Its family tree reaches back 7 generations to 1984. 666 later devices descend from it.

Decided
Jul 27, 2005
Review
55 days
Class
Class II
Product code
MQP
Recalls
None
Predicates
4

Its longest line of descent runs back 7 generations to K841189 (1984). 26 ancestors in all. 666 later devices descend from it, 8 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2005: 1 other ancestor2001: 3 other ancestors2004: 6 other ancestors2003: 4 other ancestors2002: 4 other ancestors2000: 1 other ancestor2009: 1 descendant cleared2007: 2 descendants cleared2011: 4 descendants cleared2010: 2 descendants cleared2008: 1 descendant cleared2014: 12 descendants cleared2013: 9 descendants cleared2016: 16 descendants cleared2012: 6 descendants cleared2015: 16 descendants cleared2020: 61 descendants cleared2019: 45 descendants cleared2017: 38 descendants cleared2018: 47 descendants cleared2021: 58 descendants cleared2023: 81 descendants cleared2024: 81 descendants cleared2025: 64 descendants cleared2022: 66 descendants cleared2026: 56 descendants clearedK841189 · Oec/Rezaian Spinal Fixator · Orthopedic Equipment Co., Inc. · 1984K990148 · Stackable Cage System · Depuy Motech Acromed · 1999K003043 · Surgical Titanium Mesh System · Depuyacromed · 2001×2: 2 generations cleared close together, K022793 (2003), K031757 (2003) ×2: 2 generations cleared close together, K041888 (2004), K042930 (2004) 19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 6 other ancestors3 generations back: 4 other ancestors4 generations back: 6 other ancestors5 generations back: 1 other ancestor 1 generation forward: 8 descendants2 generations forward: 27 descendants3 generations forward: 101 descendants4 generations forward: 154 descendants5 generations forward: 155 descendants6 generations forward: 125 descendants7 generations forward: 60 descendants8 generations forward: 26 descendants9 generations forward: 8 descendants10 generations forward: 1 descendant11 generations forward: 1 descendant K042930 · Spacevision Cage System · Spine Vision, Inc. · 2004K041888 · Curved Peek Tetris Spinal Implant · Signus Medizintechnik GmbH · 2004K031757 · Peek Tetris Spinal Implant · Signus Medical, LLC · 2003K022793 · Tetris Spinal Implant · Signus Medical, LLC · 2003K003043 · Surgical Titanium Mesh System · Depuyacromed · 2001K990148 · Stackable Cage System · Depuy Motech Acromed · 1999K841189 · Oec/Rezaian Spinal Fixator · Orthopedic Equipment Co., Inc. · 1984−50+5+10
  1. Root · 7 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 6 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
  3. 5 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
  4. 4 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
  5. 3 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
  6. 2 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
  7. 1 generation backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
  8. This deviceK051454 Aleutian Spacer SystemK2m, LLC · 2005
  9. Descendant · cites it directly · 663 of its ownK063399 Aleutian Spacer SystemK2m, Inc. · 2007
  10. Descendant · cites it directly · 662 of its ownK082698 Aleutian Ibf SystemK2m, Inc. · 2009
  11. Descendant · 2 generations on · 595 of its ownK101302 Aleutian Ibf SystemK2m, Inc. · 2010
  12. Descendant · cites it directly · 589 of its ownK110843 Aleutian Spacer SystemK2m, Inc. · 2011
  13. Descendant · 2 generations on · 572 of its ownK103169 AleuttianK2m, Inc. · 2011

Showing 5 of 666 descendants. See all descendants

Descendants cleared per year

2007: 22008: 12009: 12010: 22011: 42012: 62013: 92014: 122015: 162016: 162017: 382018: 472019: 452020: 612021: 582022: 662023: 812024: 812025: 642026: 56
2007high 81 (2023) · low 1 (2008)2026

Most influential descendants

Showing 5 of 666 · See all
  • K063399Aleutian Spacer SystemK2m, Inc. · 2007 · cites it directly663descendants
  • 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
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−7K841189Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc.1984—
−6K990148Stackable Cage SystemDepuy Motech Acromed1999—
−5K003043Surgical Titanium Mesh SystemDepuyacromed2001—
−4K022793Tetris Spinal ImplantSignus Medical, LLC2003—
−3K031757Peek Tetris Spinal ImplantSignus Medical, LLC2003—
−2K041888Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH2004—
−1K042930Spacevision Cage SystemSpine Vision, Inc.2004—
0 (this device)K051454Aleutian Spacer SystemK2m, LLC2005—
+1K063399Aleutian Spacer SystemK2m, Inc.2007—
+1K082698Aleutian Ibf SystemK2m, Inc.2009—
+2K101302Aleutian Ibf SystemK2m, Inc.2010—
+1K110843Aleutian Spacer SystemK2m, Inc.2011—
+2K103169AleuttianK2m, Inc.2011—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200010
200130
200240
200340
200460
200510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200720
200810
200910
201020
201140
201260
201390
2014120
2015160
2016160
2017380
2018470
2019450
2020610
2021580
2022660
2023810
2024810
2025640
2026560
FIG. 1 — Lineage of K051454, 1984–2026Source: 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), 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 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? (4)

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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

TypeNumberDeviceApplicantDecidedRecalls
*K043405Nuvasive Coroent System
Summary page 1
…tervertebral Body Fixation Orthosis ( 888.3060) 3. Predicate or legally marketed devices which are substantially equivalent * NuVasive, Inc. CoRoent system (K043405) * SpineVision, Inc. Spacevision"" Cage system (K042930) * Signus Medizintechnik GMBH RabeaTM(K()433 16)…
Nuvasive, Inc.20051
*K042930Spacevision Cage System
Summary page 1
…legally marketed devices which are substantially equivalent * NuVasive, Inc. CoRoent system (K043405) * SpineVision, Inc. Spacevision"" Cage system (K042930) * Signus Medizintechnik GMBH RabeaTM(K()433 16) TM Mesh Cage System (K003709) *…
Spine Vision, Inc.2004—
Kept off the family treeK043316FDA’s K043316 is Rabea Spinal Implant
Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
Signus Medizintechnik GmbH2005—
*K003709Surgical Dynamics Mesh Cage System
Summary page 1
…* SpineVision, Inc. Spacevision"" Cage system (K042930) * Signus Medizintechnik GMBH RabeaTM(K()433 16) TM Mesh Cage System (K003709) * Surgical Dynamnics 4. Description of the device:…
United States Surgical, A Division of Tyco Healthc2001—

Also cleared against K043405: 3 other devices →

What descends from it? (666)

See all 666

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

NumberDeviceApplicantDecidedDescendants
K063399Aleutian Spacer SystemK2m, Inc.2007663
K082698Aleutian Ibf SystemK2m, Inc.2009662
K110843Aleutian Spacer SystemK2m, Inc.2011589
K092211Chesapeake Spinal SystemK2m, Inc.2010450
K111439Chesapeake (Cervical Components)K2m, Inc.2011345
K140142Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon)Choicespine, LP2014172
K063637Reliance VBS SystemReliance Medical Systems, LLC20071
K081383Reliance VBS SystemReliance Medical Systems, LLC20080

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?

  • The line of descent spans 21 years and passes through 7 companies; a new generation was cleared every 1.0 years on median.
  • 3 of the 26 ancestors have a recall of any class.
  • Of its descendants, K063399 (K2m, Inc., 2007) has gone furthest, with 663 descendants of its own.
  • 3 other devices also cite its predicate K043405.

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.

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—

What is it indicated for?

The Aleutian Spacer System is indicated for use in the thoracolumbar spine (T1 to L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body, resected or excised for the treatment of tumors or trauma/fracture in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Aleutian Spacer System is designed to restore the biomechanical integrity of…

Read the full statement (118 words)

The Aleutian Spacer System is indicated for use in the thoracolumbar spine (T1 to L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body, resected or excised for the treatment of tumors or trauma/fracture in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Aleutian Spacer System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period.

The Aleutian Spacer System is intended to be used with supplemental internal fixation. The supplemental fixation system that may be used with this implant is the K2M Denali Spinal System.

Indications for use as stated in the FDA summary.

Also cleared against K043405

3 other devices cite the same predicate.

  • K121567Oracle Lumbar Intervertebral Body Fusion Cage SystemAccel Spine · 2012
  • K121096Venus Lumbar Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd. · 2012
  • K052210Nuvasive Coroent Extensure SystemNuvasive, Inc. · 2005

More from K2m, LLC

8 FDA decisions under this applicant name. See the company

  • K180665SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystemK2m, LLC · 2018
  • K140529Everest Spinal SystemK2m, LLC · 2014
  • K052404Denali Deformity SystemK2m, LLC · 2006
  • K060442Pyrenees Cervical Plate SystemK2m, LLC · 2006
  • K052398Mesa Spinal SystemK2m, LLC · 2005

Recent decisions in MQP

The MQP category page

  • K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group · 2026
  • K261031Poseidon STSignus Medinzintechnik GmbH · 2026
  • K253158VyBrate™ VBR SystemVy Spine, LLC · 2026
  • K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc. · 2024
  • K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG · 2024

https://510kreport.com/device/K051454 · printed Nov 6, 2026

Cite this page

510(k) Report. “K051454: Aleutian Spacer System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051454

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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