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. · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on Jul 22, 2010 as substantially equivalent to K082698 (K2m, Inc., 2009) and 1 other predicate after a 73-day review. Its family tree reaches back 10 generations to 1984. 595 later devices descend from it.
- Decided
- Jul 22, 2010
- Review
- 73 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K841189 (1984). 42 ancestors in all. 595 later devices descend from it, 8 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 deviceK101302 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 · 527 of its ownK133614 Aleutian Ibf SystemK2m, Inc. · 2014
- Descendant · 2 generations on · 459 of its ownK150481 Cascadia Interbody SystemK2m, Inc. · 2015 · Recalled
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 deviceK101302 Aleutian Ibf SystemK2m, Inc. · 2010
Showing 5 of 595 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 595 · See all- K110843Aleutian Spacer SystemK2m, Inc. · 2011 · cites it directly589descendants
- K103169AleuttianK2m, Inc. · 2011 · cites it directly572descendants
- K130699Aleutian Spinal SystemK2m, Inc. · 2013 · cites it directly570descendants
- K133614Aleutian Ibf SystemK2m, Inc. · 2014 · cites it directly527descendants
- K150481Cascadia Interbody SystemK2m, Inc. · 2015 · 2 generations on459descendants
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) | 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 | K133614 | Aleutian Ibf System | K2m, Inc. | 2014 | — |
| +2 | K150481 | Cascadia Interbody System | K2m, Inc. | 2015 | 3 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 4 | 0 |
| 2002 | 6 | 0 |
| 2003 | 7 | 0 |
| 2004 | 7 | 0 |
| 2005 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 3 | 0 |
| 2012 | 3 | 0 |
| 2013 | 3 | 0 |
| 2014 | 6 | 0 |
| 2015 | 8 | 0 |
| 2016 | 12 | 0 |
| 2017 | 32 | 0 |
| 2018 | 35 | 0 |
| 2019 | 41 | 0 |
| 2020 | 55 | 0 |
| 2021 | 57 | 0 |
| 2022 | 64 | 0 |
| 2023 | 79 | 0 |
| 2024 | 77 | 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 ODP? 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 ODP device
- #1 K222276 CONDUIT Cages; FIBERGRAFT BG Puttyscore 53.4 · 25 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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…components are made of the same materials with similar dimensions and configurations as components previously cleared in the Aleutian IBF System 5 10(k) K082698 and to the DePuy AcroMed Bengal (KOS81917). 6. Comparison of the technological characteristics of the device to predicate and l… | 2009 |
| * | K081917 | Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard Systems Our reading of the summary gave K051917, FDA’s number for Diver C.E. Catheter (Invatec Innovative Technologies, S.R.L.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “DePuy AcroMed Bengal”. | 2009 |
What descends from it? (595)
See all 5958 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K110843 | Aleutian Spacer System | 2011 | 589 |
| K103169 | Aleuttian | 2011 | 572 |
| K130699 | Aleutian Spinal System | 2013 | 570 |
| K133614 | Aleutian Ibf System | 2014 | 527 |
| K181347 | Aries® Lumbar Interbodies | 2018 | 24 |
| K122366 | Tryptik CC Anterior Intersomatic Cervical Cage | 2012 | 5 |
| K133126 | K7 Lumbar Spacers | 2013 | 1 |
| K123388 | K7C Spacer | 2013 | 0 |
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 26 years and passes through 8 companies; a new generation was cleared every 1.6 years on median.
- 3 of the 42 ancestors have a recall of any class.
- Of its descendants, K110843 (K2m, Inc., 2011) has gone furthest, with 589 descendants of its own.
- 21 other devices also cite its predicate K082698.
How does its category compare?
All ODP devicesODP Intervertebral Fusion Device With Bone Graft, Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · ODP
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ODP
87in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ODP
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ODP
57in 2025
MAUDE reports naming product code ODP, 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 | 0 | — | 0 | 0 |
| 2008 | 8 | 89 | 0 | 2 |
| 2009 | 12 | 127 | 1 | 21 |
| 2010 | 9 | 151 | 0 | 54 |
| 2011 | 25 | 113 | 1 | 38 |
| 2012 | 17 | 93 | 0 | 92 |
| 2013 | 18 | 187 | 1 | 78 |
| 2014 | 26 | 118 | 0 | 43 |
| 2015 | 24 | 180 | 0 | 51 |
| 2016 | 17 | 112 | 0 | 37 |
| 2017 | 33 | 104 | 0 | 39 |
| 2018 | 25 | 133 | 0 | 51 |
| 2019 | 22 | 92 | 0 | 141 |
| 2020 | 14 | 89 | 1 | 86 |
| 2021 | 18 | 121 | 0 | 161 |
| 2022 | 12 | 92 | 0 | 50 |
| 2023 | 34 | 165 | 0 | 36 |
| 2024 | 10 | 76 | 0 | 55 |
| 2025 | 11 | 87 | 2 | 57 |
| 2026 | 19 | 117 | 0 | — |
What is it indicated for?
When used as a cervical inter-vertebral 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 inter-vertebral 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/K101302 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101302: Aleutian Ibf System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101302
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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