510(k) · Cleared
ClearedFuselox Lumbar Interbody Fusion Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Captiva Spine · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Oct 25, 2012 as substantially equivalent to K092017 (Captiva Spine, Inc., 2009) and 2 other predicates after a 30-day review. Its family tree reaches back 11 generations to 1984. 2 later devices descend from it.
- Decided
- Oct 25, 2012
- Review
- 30 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 11 generations to K841189 (1984). 53 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 11 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 7 generations between
- 3 generations backK063399 Aleutian Spacer SystemK2m, Inc. · 2007
- 2 generations backK082698 Aleutian Ibf SystemK2m, Inc. · 2009
- 1 generation backK113138 Aleutian SystemK2m, Inc. · 2012
- This deviceK122956 Fuselox Lumbar Interbody Fusion DeviceCaptiva Spine · 2012
- Descendant · cites it directly · 1 of its ownK180990 TirboLOX-L Lumbar IBFDCaptiva Spine, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK181229 TirboLOX-C Cervical IBFDCaptiva Spine, Inc. · 2018
Show all 11 generations
- Root · 11 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 10 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 9 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 8 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 7 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 6 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 5 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 4 generations backK051454 Aleutian Spacer SystemK2m, LLC · 2005
- 3 generations backK063399 Aleutian Spacer SystemK2m, Inc. · 2007
- 2 generations backK082698 Aleutian Ibf SystemK2m, Inc. · 2009
- 1 generation backK113138 Aleutian SystemK2m, Inc. · 2012
- This deviceK122956 Fuselox Lumbar Interbody Fusion DeviceCaptiva Spine · 2012
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −10 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −9 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −8 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −7 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −6 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −5 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −4 | K051454 | Aleutian Spacer System | K2m, LLC | 2005 | — |
| −3 | K063399 | Aleutian Spacer System | K2m, Inc. | 2007 | — |
| −2 | K082698 | Aleutian Ibf System | K2m, Inc. | 2009 | — |
| −1 | K113138 | Aleutian System | K2m, Inc. | 2012 | — |
| 0 (this device) | K122956 | Fuselox Lumbar Interbody Fusion Device | Captiva Spine | 2012 | — |
| +1 | K180990 | TirboLOX-L Lumbar IBFD | Captiva Spine, Inc. | 2018 | — |
| +2 | K181229 | TirboLOX-C Cervical IBFD | Captiva Spine, Inc. | 2018 | — |
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 | 4 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 2 | 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 |
|---|---|---|---|
| * | K092017 | Pivotec Lumbar Interbody Fusion Device (Lifd)Summary page 1…Intervertebral Body Fusion Device Product Codes: MAX Panel Code: 87 Predicate Device(s): Pivotec Lumbar Interbody Fusion System (K0920 17), Aleutian IBF System (KI 13138), and Lumbar I/F Cage (P960025) Reason for this Submission: This Sp… | 2009 |
| * | K113138 | Aleutian System | 2012 |
| * | P960025 | Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle ScrewsSummary page 1…87 Predicate Device(s): Pivotec Lumbar Interbody Fusion System (K0920 17), Aleutian IBF System (KI 13138), and Lumbar I/F Cage (P960025) Reason for this Submission: This Special 5 10(k) involves several changes to the previously cleared Pivotec System that allow f… | 1999 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K180990 | TirboLOX-L Lumbar IBFD | 2018 | 1 |
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 9 companies; a new generation was cleared every 1.6 years on median.
- 8 of the 53 ancestors have a recall of any class.
- Of its descendants, K180990 (Captiva Spine, Inc., 2018) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K092017.
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?
The FuseLOX Lumbar Interbody Fusion Device is an intervertebral body fusion device indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients…
Read the full statement (115 words)
The FuseLOX Lumbar Interbody Fusion Device is an intervertebral body fusion device indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.
The FuseLOX Lumbar Interbody Fusion Device is designed for use with autograft to facilitate fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122956 · printed Nov 5, 2026
Cite this page
510(k) Report. “K122956: Fuselox Lumbar Interbody Fusion Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K122956
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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