510(k) · Cleared
ClearedAleutian 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 Jan 10, 2012 as substantially equivalent to K082698 (K2m, Inc., 2009) and 2 other predicates after a 77-day review. Its family tree reaches back 10 generations to 1984. 549 later devices descend from it.
- Decided
- Jan 10, 2012
- Review
- 77 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 10 generations to K841189 (1984). 47 ancestors in all. 549 later devices descend from it, 6 citing it directly.
- Root · 10 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 6 generations between
- 3 generations backK051454 Aleutian Spacer SystemK2m, LLC · 2005
- 2 generations backK063399 Aleutian Spacer SystemK2m, Inc. · 2007
- 1 generation backK082698 Aleutian Ibf SystemK2m, Inc. · 2009
- This deviceK113138 Aleutian SystemK2m, Inc. · 2012
- Descendant · cites it directly · 527 of its ownK133614 Aleutian Ibf SystemK2m, Inc. · 2014
- Descendant · cites it directly · 459 of its ownK150481 Cascadia Interbody SystemK2m, Inc. · 2015 · Recalled
- Descendant · 2 generations on · 315 of its ownK160125 Cascadia Interbody SystemK2m · 2016
- Descendant · 2 generations on · 276 of its ownK163230 NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated · 2017
- Descendant · 2 generations on · 237 of its ownK143126 Renovis S141 Lumbar Interbody Cage SystemRenovis Surgical Technologies · 2015
Show all 10 generations
- Root · 10 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 9 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 8 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 7 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 6 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 5 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 4 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 3 generations backK051454 Aleutian Spacer SystemK2m, LLC · 2005
- 2 generations backK063399 Aleutian Spacer SystemK2m, Inc. · 2007
- 1 generation backK082698 Aleutian Ibf SystemK2m, Inc. · 2009
- This deviceK113138 Aleutian SystemK2m, Inc. · 2012
Showing 5 of 549 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 549 · See all- K133614Aleutian Ibf SystemK2m, Inc. · 2014 · cites it directly527descendants
- K150481Cascadia Interbody SystemK2m, Inc. · 2015 · cites it directly459descendants
- K160125Cascadia Interbody SystemK2m · 2016 · 2 generations on315descendants
- K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated · 2017 · 2 generations on276descendants
- K143126Renovis S141 Lumbar Interbody Cage SystemRenovis Surgical Technologies · 2015 · 2 generations on237descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −9 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −8 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −7 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −6 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −5 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −4 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −3 | K051454 | Aleutian Spacer System | K2m, LLC | 2005 | — |
| −2 | K063399 | Aleutian Spacer System | K2m, Inc. | 2007 | — |
| −1 | K082698 | Aleutian Ibf System | K2m, Inc. | 2009 | — |
| 0 (this device) | K113138 | Aleutian System | K2m, Inc. | 2012 | — |
| +1 | K133614 | Aleutian Ibf System | K2m, Inc. | 2014 | — |
| +1 | K150481 | Cascadia Interbody System | K2m, Inc. | 2015 | 3 |
| +2 | K160125 | Cascadia Interbody System | K2m | 2016 | — |
| +2 | K163230 | NuVasive Modulus XLIF Interbody System | Nu Vasive, Incorporated | 2017 | — |
| +2 | K143126 | Renovis S141 Lumbar Interbody Cage System | Renovis Surgical Technologies | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 8 | 0 |
| 2002 | 5 | 0 |
| 2003 | 4 | 0 |
| 2004 | 8 | 0 |
| 2005 | 3 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 2 | 0 |
| 2015 | 6 | 0 |
| 2016 | 9 | 0 |
| 2017 | 29 | 0 |
| 2018 | 31 | 0 |
| 2019 | 39 | 0 |
| 2020 | 56 | 0 |
| 2021 | 51 | 0 |
| 2022 | 57 | 0 |
| 2023 | 76 | 0 |
| 2024 | 76 | 0 |
| 2025 | 59 | 0 |
| 2026 | 54 | 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? (3)
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 |
|---|---|---|---|
| * | K082698 | Aleutian Ibf SystemSummary page 2…which demonstrated that the subject Aleutian Spinal System components are substantially equivalent to devices previously cleared in K2M's Aleutian Spinal System (K082698), NuVasive's CoRoent System (KO71795) and DiFusion Technology's (K 100042). 6. Comparison of the technological characte… | 2009 |
| * | K071795 | Nuvasive Coroent System | 2007 |
| * | K100042 | Difusion Technologies Xiphos Interbody Fusion SystemSummary page 2…substantially equivalent to devices previously cleared in K2M's Aleutian Spinal System (K082698), NuVasive's CoRoent System (KO71795) and DiFusion Technology's (K 100042). 6. Comparison of the technological characteristics of the device to predicate and legally marketed devices: Finite e… | 2010 |
What descends from it? (549)
See all 5496 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 28 years and passes through 8 companies; a new generation was cleared every 1.7 years on median.
- 7 of the 47 ancestors have a recall of any class.
- Of its descendants, K133614 (K2m, Inc., 2014) has gone furthest, with 527 descendants of its own.
- 21 other devices also cite its predicate K082698.
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. 2012, 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 fuision device, the Aleutian implants are indicated for spinal fusion, procedures to be used with autogenous bone grail in skeletally mature patients. Cervical IBF implants are intended for use at one level in the cervical spine, from C2 to T I, 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 (323 words)
When used as a cervical intervertebral body fuision device, the Aleutian implants are indicated for spinal fusion, procedures to be used with autogenous bone grail in skeletally mature patients. Cervical IBF implants are intended for use at one level in the cervical spine, from C2 to T I, 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 IBE 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 1 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 intefided 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 (TI 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/K113138 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113138: Aleutian System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113138
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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