510(k) · Cleared
ClearedAleutian Spacer System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
K2m, Inc. · MQP Spinal Vertebral Body Replacement Device
Cleared on Feb 23, 2007 as substantially equivalent to K051454 (K2m, LLC, 2005) after a 106-day review. Its family tree reaches back 8 generations to 1984. 663 later devices descend from it.
- Decided
- Feb 23, 2007
- Review
- 106 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K841189 (1984). 27 ancestors in all. 663 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 7 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 6 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 5 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 4 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 3 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 2 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 1 generation backK051454 Aleutian Spacer SystemK2m, LLC · 2005
- This deviceK063399 Aleutian Spacer SystemK2m, Inc. · 2007
- Descendant · cites it directly · 662 of its ownK082698 Aleutian Ibf SystemK2m, Inc. · 2009
- Descendant · 2 generations on · 595 of its ownK101302 Aleutian Ibf SystemK2m, Inc. · 2010
- Descendant · cites it directly · 589 of its ownK110843 Aleutian Spacer SystemK2m, Inc. · 2011
- Descendant · 2 generations on · 572 of its ownK103169 AleuttianK2m, Inc. · 2011
- 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
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
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −7 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −6 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −5 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −4 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −3 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −2 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −1 | K051454 | Aleutian Spacer System | K2m, LLC | 2005 | — |
| 0 (this device) | K063399 | Aleutian Spacer System | K2m, Inc. | 2007 | — |
| +1 | K082698 | Aleutian Ibf System | K2m, Inc. | 2009 | — |
| +2 | K101302 | Aleutian Ibf System | K2m, Inc. | 2010 | — |
| +1 | K110843 | Aleutian Spacer System | K2m, Inc. | 2011 | — |
| +2 | K103169 | Aleuttian | K2m, Inc. | 2011 | — |
| +2 | K130699 | Aleutian Spinal System | K2m, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 4 | 0 |
| 2003 | 4 | 0 |
| 2004 | 6 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 4 | 0 |
| 2012 | 6 | 0 |
| 2013 | 9 | 0 |
| 2014 | 12 | 0 |
| 2015 | 16 | 0 |
| 2016 | 16 | 0 |
| 2017 | 38 | 0 |
| 2018 | 47 | 0 |
| 2019 | 45 | 0 |
| 2020 | 61 | 0 |
| 2021 | 58 | 0 |
| 2022 | 66 | 0 |
| 2023 | 81 | 0 |
| 2024 | 81 | 0 |
| 2025 | 64 | 0 |
| 2026 | 56 | 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.
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 K261810 Vertiwedge® Intraosseous Systemscore 18.1 · 22 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K051454 | Aleutian Spacer SystemSummary page 1…e subject Aleutian Spacer System components are substantially equivalent to the components previously cleared in the Aleutian Spacer System 5 10(k) KO051454 (SE 07/27/2005). 6. Comparison of the technological characteristics of the device to predicate and legally marketed devices:… | 2005 |
What descends from it? (663)
See all 6632 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 23 years and passes through 8 companies; a new generation was cleared every 1.6 years on median.
- 3 of the 27 ancestors have a recall of any class.
- Of its descendants, K082698 (K2m, Inc., 2009) has gone furthest, with 662 descendants of its own.
- 7 other devices also cite its predicate K051454.
How does its category compare?
All MQP devicesMQP Spinal Vertebral Body Replacement Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · MQP
4in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MQP
187in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MQP
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQP
168in 2025
MAUDE reports naming product code MQP, 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 | 30 | 107 | 2 | 61 |
| 2008 | 17 | 47 | 0 | 76 |
| 2009 | 11 | 115 | 14 | 111 |
| 2010 | 6 | 174 | 2 | 166 |
| 2011 | 8 | 237 | 1 | 121 |
| 2012 | 7 | 82 | 2 | 141 |
| 2013 | 3 | 90 | 0 | 207 |
| 2014 | 5 | 125 | 0 | 216 |
| 2015 | 8 | 126 | 0 | 258 |
| 2016 | 0 | — | 0 | 129 |
| 2017 | 9 | 97 | 0 | 141 |
| 2018 | 6 | 152 | 0 | 130 |
| 2019 | 8 | 93 | 0 | 117 |
| 2020 | 3 | 103 | 15 | 157 |
| 2021 | 0 | — | 0 | 208 |
| 2022 | 1 | — | 1 | 137 |
| 2023 | 1 | — | 0 | 71 |
| 2024 | 4 | 187 | 0 | 98 |
| 2025 | 0 | — | 0 | 168 |
| 2026 | 3 | 102 | 0 | — |
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 (123 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 Denali Spinal System, Denali Deformity and Mesa Spinal system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063399 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063399: 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/K063399
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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