510(k) · Cleared
ClearedNanovis Intervertebral Body Fusion System and Forticore (R)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nanovis, LLC · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Sep 6, 2016 as substantially equivalent to K110442 (Nanovis, LLC, 2011) and 2 other predicates after a 98-day review. Its family tree reaches back 15 generations to 2001. 1 of the 122 devices in its family, counting itself, has a Class I recall. 5 later devices descend from it.
- Decided
- Sep 6, 2016
- Review
- 98 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 15 generations to K003155 (2001). 116 ancestors in all, the oldest K792352 (1979). 5 later devices descend from it, 3 citing it directly. 1 of the 122 devices in this family, counting this one, has a Class I recall.
- Root · 15 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 11 generations between
- 3 generations backK100214 Cornerstone PSR Cervical Interbody Fusion DeviceMedtronic Sofamor Danek · 2010
- 2 generations backK110442 Nanovis Intervertebral Body Fusion SystemNanovis, LLC · 2011
- 1 generation backK140280 ForticoreNanovis, LLC · 2014
- This deviceK161485 Nanovis Intervertebral Body Fusion System and Forticore (R)Nanovis, LLC · 2016
- Descendant · cites it directly · 3 of its ownK171312 FortiCore®Nanovis, LLC · 2018
- Descendant · cites it directly · 2 of its ownK191822 Nano FortiCore, FortiCoreNanovis, LLC · 2019
- Descendant · 2 generations on · 0 of its ownK241605 Adaptix™ PEEK Interbody System with Nanotechnology; Capstone…Nanovis, LLC · 2024
- Descendant · 2 generations on · 0 of its ownK230936 Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC · 2023
- Descendant · cites it directly · 0 of its ownK173832 InTice™-C Porous Ti Cervical Interbody SystemX-Spine Systems, Inc. · 2018 · Recalled
Show all 15 generations
- Root · 15 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 14 generations backK012254 VBROsteotech, Inc. · 2001
- 13 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 12 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 11 generations backK030601 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 10 generations backK040536 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 9 generations backK041556 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 8 generations backK043561 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 7 generations backK060719 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
- 6 generations backK062133 Modification to Verte-Stack Spinal SystemMedtronic Spinal and Biologics Div · 2006
- 5 generations backK070173 Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc. · 2007
- 4 generations backK073285 Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek USA, Inc. · 2008
- 3 generations backK100214 Cornerstone PSR Cervical Interbody Fusion DeviceMedtronic Sofamor Danek · 2010
- 2 generations backK110442 Nanovis Intervertebral Body Fusion SystemNanovis, LLC · 2011
- 1 generation backK140280 ForticoreNanovis, LLC · 2014
- This deviceK161485 Nanovis Intervertebral Body Fusion System and Forticore (R)Nanovis, LLC · 2016
Class I recalls in this family
- K073202 Ardis Spacer2 generations back · 2008
Most influential descendants
Showing 5 of 5 · See all- K171312FortiCore®Nanovis, LLC · 2018 · cites it directly3descendants
- K191822Nano FortiCore, FortiCoreNanovis, LLC · 2019 · cites it directly2descendants
- K241605Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System…Nanovis, LLC · 2024 · 2 generations on0descendants
- K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC · 2023 · 2 generations on0descendants
- K173832InTice™-C Porous Ti Cervical Interbody SystemX-Spine Systems, Inc. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −14 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −13 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −12 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −11 | K030601 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −10 | K040536 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −9 | K041556 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −8 | K043561 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −7 | K060719 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −6 | K062133 | Modification to Verte-Stack Spinal System | Medtronic Spinal and Biologics Div | 2006 | — |
| −5 | K070173 | Verte-Stack Spinal System | Medtronic Sofamor Danek, Inc. | 2007 | — |
| −4 | K073285 | Peek Prevail Cervical Interbody Device | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −3 | K100214 | Cornerstone PSR Cervical Interbody Fusion Device | Medtronic Sofamor Danek | 2010 | — |
| −2 | K110442 | Nanovis Intervertebral Body Fusion System | Nanovis, LLC | 2011 | — |
| −1 | K140280 | Forticore | Nanovis, LLC | 2014 | — |
| 0 (this device) | K161485 | Nanovis Intervertebral Body Fusion System and Forticore (R) | Nanovis, LLC | 2016 | — |
| +1 | K171312 | FortiCore® | Nanovis, LLC | 2018 | — |
| +1 | K191822 | Nano FortiCore, FortiCore | Nanovis, LLC | 2019 | — |
| +2 | K241605 | Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK… | Nanovis, LLC | 2024 | — |
| +2 | K230936 | Anatomic PEEK™ Cervical Fusion System with Nanotechnology | Nanovis, LLC | 2023 | — |
| +1 | K173832 | InTice™-C Porous Ti Cervical Interbody System | X-Spine Systems, Inc. | 2018 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1984 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 3 | 0 |
| 2000 | 1 | 0 |
| 2001 | 8 | 0 |
| 2002 | 6 | 0 |
| 2003 | 13 | 0 |
| 2004 | 16 | 0 |
| 2005 | 6 | 0 |
| 2006 | 3 | 0 |
| 2007 | 10 | 0 |
| 2008 | 14 | 1 |
| 2009 | 8 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 2 | 0 |
| 2019 | 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.
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? (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 |
|---|---|---|---|
| * | K110442 | Nanovis Intervertebral Body Fusion SystemSummary page 6…Core® devices also incorporate a tantalum marker per ASTM F560. Primary Predicate: Nanovis Intervertebral Body Fusion System (Nanovis LLC, K110442) Additional Predicates: FortiCore® (Nanovis LLC, K140280) Aleutian® IBF System (K2M, Inc., K133614) Pe… | 2011 |
| * | K140280 | ForticoreSummary page 6…marker per ASTM F560. Primary Predicate: Nanovis Intervertebral Body Fusion System (Nanovis LLC, K110442) Additional Predicates: FortiCore® (Nanovis LLC, K140280) Aleutian® IBF System (K2M, Inc., K133614) Performance Data: Static and dynamic compression testi… | 2014 |
| * | K133614 | Aleutian Ibf SystemSummary page 6…rvertebral Body Fusion System (Nanovis LLC, K110442) Additional Predicates: FortiCore® (Nanovis LLC, K140280) Aleutian® IBF System (K2M, Inc., K133614) Performance Data: Static and dynamic compression testing per ASTM F2077 and/or dimensional analy… | 2014 |
What descends from it? (5)
3 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.
- K073202Ardis SpacerAbbott Spine, Inc. · 2008 · 2 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 15 years and passes through 6 companies; a new generation was cleared every 10 months on median.
- 12 of the 116 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K171312 (Nanovis, LLC, 2018) has gone furthest, with 3 descendants of its own.
- 3 other devices also cite its predicate K110442.
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?
When used as a cervical intervertebral body fusion device, the Nanovis Intervertebral Body Fusion System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) at one spinal level from C2-T1. These patients should have had at least six weeks of non-operative treatment. Nanovis…
Read the full statement (392 words)
When used as a cervical intervertebral body fusion device, the Nanovis Intervertebral Body Fusion System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) at one spinal level from C2-T1. These patients should have had at least six weeks of non-operative treatment. Nanovis Intervertebral Body Fusion System implants are to be used with autogenous bone graft and in combination with supplemental fixation indicated for cervical fusion procedures.
When used as a lumbar intervertebral body fusion device, the Nanovis Intervertebral Body Fusion System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies) at one or two contiguous spinal levels from L2-S1. These patients should have had six months of nonoperative treatment. These patients may have had a previous non-fusion spinal surgery and/or may have up to Grade I spondylolisthesis or retrolisthesis at the involved spinal level(s). Nanovis Intervertebral Body Fusion System implants are to be used with autogenous bone graft and in combination with supplemental fixation indicated for lumbar spinal fusion procedures.
When used as a cervical intervertebral body fusion device, FortiCore® is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) at one spinal level from C2-T1. These patients should have had at least six weeks of non-operative treatment. FortiCore® devices are to be used with autogenous bone graft and in combination with supplemental fixation indicated for cervical fusion procedures.
When used as a lumbar intervertebral body fusion device, FortiCore® is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies) at one or two contiguous spinal levels from L2-S1. These patients should have had six months of nonoperative treatment. These patients may have had a previous non-fusion spinal surgery and/or may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved spinal level(s). FortiCore® devices are to be used with autogenous bone graft and in combination with supplemental fixation indicated for lumbar spinal fusion procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161485 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161485: Nanovis Intervertebral Body Fusion System and Forticore (R).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161485
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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