510(k) · Cleared
ClearedValeo II Interbody Fusion Device 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 Aug 19, 2016 as substantially equivalent to K121892 (Amedica Corp., 2012) and 2 other predicates after a 91-day review. Its family tree reaches back 12 generations to 1984. 4 later devices descend from it.
- Decided
- Aug 19, 2016
- Review
- 91 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 12 generations to K841189 (1984). 46 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 12 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 8 generations between
- 3 generations backK080401 Shell Cage, Wave Cage, Loop CageAdvanced Medical Technologies AG · 2008
- 2 generations backK082801 Phantom Plus Cage SystemUs Spine · 2008
- 1 generation backK121892 Phantom Plus Ceramic Cage SystemAmedica Corp. · 2012
- This deviceK161405 Valeo II Interbody Fusion Device SystemAmedica Corp. · 2016
- Descendant · cites it directly · 3 of its ownK192863 MONDRIAN Lumbar Interbody Fusion Cage SystemCtl Medical Corporation · 2020
- Descendant · 2 generations on · 1 of its ownK213641 MONDRIAN ALIF Cage with Supplementary Fixation PlateCtl Medical Corporation · 2022
- Descendant · 3 generations on · 0 of its ownK231715 MONDRIAN™ Anterior Lumbar Plate SystemCtl Medical Corporation · 2024
- Descendant · cites it directly · 0 of its ownK220513 NITRO Interbody Fusion Cage System FamilyCtl Medical Corporation · 2023
Show all 12 generations
- Root · 12 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 11 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 10 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 9 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 8 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 7 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 6 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 5 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 4 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 3 generations backK080401 Shell Cage, Wave Cage, Loop CageAdvanced Medical Technologies AG · 2008
- 2 generations backK082801 Phantom Plus Cage SystemUs Spine · 2008
- 1 generation backK121892 Phantom Plus Ceramic Cage SystemAmedica Corp. · 2012
- This deviceK161405 Valeo II Interbody Fusion Device SystemAmedica Corp. · 2016
Most influential descendants
Showing 4 of 4 · See all- K192863MONDRIAN Lumbar Interbody Fusion Cage SystemCtl Medical Corporation · 2020 · cites it directly3descendants
- K213641MONDRIAN ALIF Cage with Supplementary Fixation PlateCtl Medical Corporation · 2022 · 2 generations on1descendant
- K231715MONDRIAN™ Anterior Lumbar Plate SystemCtl Medical Corporation · 2024 · 3 generations on0descendants
- K220513NITRO Interbody Fusion Cage System FamilyCtl Medical Corporation · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −11 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −10 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −9 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −8 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −7 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −6 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −5 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −4 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −3 | K080401 | Shell Cage, Wave Cage, Loop Cage | Advanced Medical Technologies AG | 2008 | — |
| −2 | K082801 | Phantom Plus Cage System | Us Spine | 2008 | — |
| −1 | K121892 | Phantom Plus Ceramic Cage System | Amedica Corp. | 2012 | — |
| 0 (this device) | K161405 | Valeo II Interbody Fusion Device System | Amedica Corp. | 2016 | — |
| +1 | K192863 | MONDRIAN Lumbar Interbody Fusion Cage System | Ctl Medical Corporation | 2020 | — |
| +2 | K213641 | MONDRIAN ALIF Cage with Supplementary Fixation Plate | Ctl Medical Corporation | 2022 | — |
| +3 | K231715 | MONDRIAN™ Anterior Lumbar Plate System | Ctl Medical Corporation | 2024 | — |
| +1 | K220513 | NITRO Interbody Fusion Cage System Family | Ctl Medical Corporation | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 5 | 0 |
| 2002 | 4 | 0 |
| 2003 | 5 | 0 |
| 2004 | 5 | 0 |
| 2005 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 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 |
|---|---|---|---|
| * | K121892 | Phantom Plus Ceramic Cage SystemSummary page 4…ntervertebral body fusion device Class: II Product Codes: MAX, ODP Primary Predicate: Valeo II™ Interbody Fusion Device (K121892) Additional Predicates: Globus PATRIOT® TransContinental® Llif Spacer (K093242) Valeo IITM In… | 2012 |
| * | K093242 | Patriot Transcontinental Llif SpacerSummary page 4…MAX, ODP Primary Predicate: Valeo II™ Interbody Fusion Device (K121892) Additional Predicates: Globus PATRIOT® TransContinental® Llif Spacer (K093242) Valeo IITM Interbody Fusion Device (K143518) Indications For Use: Valeo II Interbody Fusion Devic… | 2009 |
| * | K143518 | Valeo Spacer System and Valeo II Interbody Fusion Device SystemSummary page 4…n Device (K121892) Additional Predicates: Globus PATRIOT® TransContinental® Llif Spacer (K093242) Valeo IITM Interbody Fusion Device (K143518) Indications For Use: Valeo II Interbody Fusion Devices - Cervical are indicated for use in skeletally mature patients with deg… | 2015 |
What descends from it? (4)
2 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 32 years and passes through 10 companies; a new generation was cleared every 1.7 years on median.
- 2 of the 46 ancestors have a recall of any class.
- Of its descendants, K192863 (Ctl Medical Corporation, 2020) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K121892.
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. 2016, 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?
Valeo II Interbody Fusion Devices - Cervical are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level or two contiguous levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Valeo II Interbody Fusion Devices-Cervical are used to facilitate intervertebral body fusion in the…
Read the full statement (239 words)
Valeo II Interbody Fusion Devices - Cervical are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level or two contiguous levels.
DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Valeo II Interbody Fusion Devices-Cervical are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach from the C2-C3 disc space to C7-T1 disc space using autograft or allogenicbone graft comprised of cancellous and/or corticocancelous bone graft.
Valeo II Interbody Fusion Devices-Cervical are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.
Valeo II Interbody Fusion Devices-Lumbar are indicated for use with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.
DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s).
Valeo II Interbody Fusion Devices-Lumbar are intended to be used with supplemental spinal fixation systems. Patients should be skeletally mature and have six months of non-operative therapy prior to treatment with an intervertebral cage.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161405 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161405: Valeo II Interbody Fusion Device System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161405
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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