510(k) · Cleared
ClearedAleutian Ibf System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
K2m, Inc. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Apr 21, 2009 as substantially equivalent to K051454 (K2m, LLC, 2005) and 2 other predicates after a 218-day review. Its family tree reaches back 9 generations to 1984. 662 later devices descend from it.
- Decided
- Apr 21, 2009
- Review
- 218 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K841189 (1984). 29 ancestors in all. 662 later devices descend from it, 22 citing it directly.
- 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 backK051454 Aleutian Spacer SystemK2m, LLC · 2005
- 1 generation backK063399 Aleutian Spacer SystemK2m, Inc. · 2007
- This deviceK082698 Aleutian Ibf SystemK2m, Inc. · 2009
- Descendant · cites it directly · 595 of its ownK101302 Aleutian Ibf SystemK2m, Inc. · 2010
- Descendant · cites it directly · 589 of its ownK110843 Aleutian Spacer SystemK2m, Inc. · 2011
- Descendant · cites it directly · 572 of its ownK103169 AleuttianK2m, Inc. · 2011
- Descendant · cites it directly · 570 of its ownK130699 Aleutian Spinal SystemK2m, Inc. · 2013
- Descendant · cites it directly · 549 of its ownK113138 Aleutian SystemK2m, Inc. · 2012
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 backK051454 Aleutian Spacer SystemK2m, LLC · 2005
- 1 generation backK063399 Aleutian Spacer SystemK2m, Inc. · 2007
- This deviceK082698 Aleutian Ibf SystemK2m, Inc. · 2009
Showing 5 of 662 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 662 · See all- K101302Aleutian Ibf SystemK2m, Inc. · 2010 · cites it directly595descendants
- K110843Aleutian Spacer SystemK2m, Inc. · 2011 · cites it directly589descendants
- K103169AleuttianK2m, Inc. · 2011 · cites it directly572descendants
- K130699Aleutian Spinal SystemK2m, Inc. · 2013 · cites it directly570descendants
- K113138Aleutian SystemK2m, Inc. · 2012 · cites it directly549descendants
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 | K051454 | Aleutian Spacer System | K2m, LLC | 2005 | — |
| −1 | K063399 | Aleutian Spacer System | K2m, Inc. | 2007 | — |
| 0 (this device) | K082698 | Aleutian Ibf System | K2m, Inc. | 2009 | — |
| +1 | K101302 | Aleutian Ibf System | K2m, Inc. | 2010 | — |
| +1 | K110843 | Aleutian Spacer System | K2m, Inc. | 2011 | — |
| +1 | K103169 | Aleuttian | K2m, Inc. | 2011 | — |
| +1 | K130699 | Aleutian Spinal System | K2m, Inc. | 2013 | — |
| +1 | K113138 | Aleutian System | K2m, Inc. | 2012 | — |
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 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 MAX? 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K051454 | Aleutian Spacer SystemSummary page 2…that the subject Aleutian IBF System components are substantially equivalent to the components previously cleared in the Aleutian Spacer System 510(k)'s K051454, K063399, and K080024 and to the Pioneer Intervertebral Fusion Device System. 6. Comparison of the technological characteristic… | 2005 |
| * | K063399 | Aleutian Spacer SystemSummary page 2…subject Aleutian IBF System components are substantially equivalent to the components previously cleared in the Aleutian Spacer System 510(k)'s K051454, K063399, and K080024 and to the Pioneer Intervertebral Fusion Device System. 6. Comparison of the technological characteristics of the… | 2007 |
| * | K080024 | Aleutian Spacer, Model K2-07-1004-01, K2-07-1005-01Summary page 2…tian IBF System components are substantially equivalent to the components previously cleared in the Aleutian Spacer System 510(k)'s K051454, K063399, and K080024 and to the Pioneer Intervertebral Fusion Device System. 6. Comparison of the technological characteristics of the device to pre… | 2008 |
| * | — | Pioneer Intervertebral Fusion Device System Named without a submission number |
What descends from it? (662)
See all 66222 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101302 | Aleutian Ibf System | 2010 | 595 |
| K110843 | Aleutian Spacer System | 2011 | 589 |
| K103169 | Aleuttian | 2011 | 572 |
| K130699 | Aleutian Spinal System | 2013 | 570 |
| K113138 | Aleutian System | 2012 | 549 |
| K133614 | Aleutian Ibf System | 2014 | 527 |
| K150481 | Cascadia Interbody System | 2015 | 459 |
| K092211 | Chesapeake Spinal System | 2010 | 450 |
| K111439 | Chesapeake (Cervical Components) | 2011 | 345 |
| K120031 | Chesapeake Spinal System | 2012 | 334 |
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 25 years and passes through 8 companies; a new generation was cleared every 1.6 years on median.
- 3 of the 29 ancestors have a recall of any class.
- Of its descendants, K101302 (K2m, Inc., 2010) has gone furthest, with 595 descendants of its own.
- 7 other devices also cite its predicate K051454.
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. 2009, 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?
When used as a cervical intervertebral body fusion device, the Aleutian implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. Cervical IBF implants are intended for use at one level in the cervical spine, from C2 to T1, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The…
Read the full statement (322 words)
When used as a cervical intervertebral body fusion device, the Aleutian implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. Cervical IBF implants are intended for use at one level in the cervical spine, from C2 to T1, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is intended to be used in patients who have had six weeks of non-operative treatment.
When used as a lumbar intervertebral body fusion device, the Aleutian implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. The lumbar IBF implants are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is intended to be used in patients who have had six months of non-operative treatment.
When used as vertebral body replacement devices the Aleutian implants are 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 implants are designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period. For all the above indications the Aleutian implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including K2M Pedicle Screw and Hook Systems, and K2M Spinal Plate Systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082698 · printed Nov 5, 2026
Cite this page
510(k) Report. “K082698: Aleutian Ibf System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K082698
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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