510(k) · Cleared
ClearedValeo Spacer System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Amedica Corp. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Jan 28, 2010 after a 272-day review. The FDA summary names no predicate by number. 1 of the 602 devices in its family, counting itself, has a Class I recall. 601 later devices descend from it.
- Decided
- Jan 28, 2010
- Review
- 272 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 0
601 later devices descend from it, 4 citing it directly. 1 of the 602 devices in this family, counting this one, has a Class I recall.
- This deviceK091278 Valeo Spacer SystemAmedica Corp. · 2010
- Descendant · cites it directly · 595 of its ownK131082 Interform Interbody Cage SystemNext Orthosurgical · 2013
- Descendant · 2 generations on · 588 of its ownK141665 NuVasive CoRoent SystemNuvasive, Inc. · 2015
- Descendant · 3 generations on · 479 of its ownK151472 NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated · 2015
- Descendant · 3 generations on · 402 of its ownK150994 NuVasive CoRoent Thoracolumbar ImplantsNu Vasive, Incorporated · 2015
- Descendant · 4 generations on · 400 of its ownK153419 NuVasive CoRoent Thoracolumbar SystemNu Vasive, Incorporated · 2016
Showing 5 of 601 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub5 generations on · 2021
Most influential descendants
Showing 5 of 601 · See all- K131082Interform Interbody Cage SystemNext Orthosurgical · 2013 · cites it directly595descendants
- K141665NuVasive CoRoent SystemNuvasive, Inc. · 2015 · 2 generations on588descendants
- K151472NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated · 2015 · 3 generations on479descendants
- K150994NuVasive CoRoent Thoracolumbar ImplantsNu Vasive, Incorporated · 2015 · 3 generations on402descendants
- K153419NuVasive CoRoent Thoracolumbar SystemNu Vasive, Incorporated · 2016 · 4 generations on400descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K091278 | Valeo Spacer System | Amedica Corp. | 2010 | — |
| +1 | K131082 | Interform Interbody Cage System | Next Orthosurgical | 2013 | — |
| +2 | K141665 | NuVasive CoRoent System | Nuvasive, Inc. | 2015 | — |
| +3 | K151472 | NuVasive CoRoent Lumbar System | Nu Vasive, Incorporated | 2015 | — |
| +3 | K150994 | NuVasive CoRoent Thoracolumbar Implants | Nu Vasive, Incorporated | 2015 | — |
| +4 | K153419 | NuVasive CoRoent Thoracolumbar System | Nu Vasive, Incorporated | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 10 | 0 |
| 2016 | 18 | 0 |
| 2017 | 29 | 0 |
| 2018 | 31 | 0 |
| 2019 | 44 | 0 |
| 2020 | 64 | 0 |
| 2021 | 51 | 1 |
| 2022 | 61 | 0 |
| 2023 | 76 | 0 |
| 2024 | 83 | 0 |
| 2025 | 73 | 0 |
| 2026 | 58 | 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.
1 device in this family has a Class I recall. 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?
The FDA summary names no predicate by number.
What descends from it? (601)
See all 6014 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 5 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K131082 (Next Orthosurgical, 2013) has gone furthest, with 595 descendants of its own.
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. 2010, 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 Valeo® Spacer System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device system is designed for use with autograft to facilitate fusion. The device must be used with additional anterior or posterior instrumentation to augment stability. The Valeo® Spacer System -C is intended for use at one level in the cervical spine, from C3 to T1, for the treatment of cervical disc disease (defined as neck pain of…
Read the full statement (191 words)
The Valeo® Spacer System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device system is designed for use with autograft to facilitate fusion. The device must be used with additional anterior or posterior instrumentation to augment stability.
The Valeo® Spacer System -C is intended for use at one level in the cervical spine, from C3 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 Valeo® Spacer System -C is to be used in patients who have had six weeks of non-operative treatment.
The Valeo® Spacer System -AL, -TL, -PL, -XT 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 Valeo® Spacer System -AL, -TL, -PL, -XT is to be used in patients who have had six months of non-operative treatment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091278 · printed Nov 5, 2026
Cite this page
510(k) Report. “K091278: Valeo Spacer System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K091278
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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