510(k) · Cleared
ClearedNanovis Intervertebral Body Fusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nanovis, LLC · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on Nov 9, 2011 as substantially equivalent to K091088 (Ldr Spine USA, 2009) and 11 other predicates after a 266-day review. Its family tree reaches back 13 generations to 2001. 1 of the 95 devices in its family, counting itself, has a Class I recall. 10 later devices descend from it.
- Decided
- Nov 9, 2011
- Review
- 266 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 12
Its longest line of descent runs back 13 generations to K003155 (2001). 84 ancestors in all, the oldest K792352 (1979). 10 later devices descend from it, 4 citing it directly. 1 of the 95 devices in this family, counting this one, has a Class I recall.
- Root · 13 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 9 generations between
- 3 generations backK070173 Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc. · 2007
- 2 generations backK073285 Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek USA, Inc. · 2008
- 1 generation backK100214 Cornerstone PSR Cervical Interbody Fusion DeviceMedtronic Sofamor Danek · 2010
- This deviceK110442 Nanovis Intervertebral Body Fusion SystemNanovis, LLC · 2011
- Descendant · cites it directly · 9 of its ownK140280 ForticoreNanovis, LLC · 2014
- Descendant · cites it directly · 5 of its ownK161485 Nanovis Intervertebral Body Fusion System and Forticore (R)Nanovis, LLC · 2016
- Descendant · cites it directly · 4 of its ownK160874 Nanovis Intervertebral Body Fusion System and FortiCore®Nanovis, LLC · 2016
- Descendant · 2 generations on · 3 of its ownK171312 FortiCore®Nanovis, LLC · 2018
- Descendant · cites it directly · 2 of its ownK191822 Nano FortiCore, FortiCoreNanovis, LLC · 2019
Show all 13 generations
- Root · 13 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 12 generations backK012254 VBROsteotech, Inc. · 2001
- 11 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 10 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 9 generations backK030601 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 8 generations backK040536 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 7 generations backK041556 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 6 generations backK043561 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 5 generations backK060719 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
- 4 generations backK062133 Modification to Verte-Stack Spinal SystemMedtronic Spinal and Biologics Div · 2006
- 3 generations backK070173 Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc. · 2007
- 2 generations backK073285 Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek USA, Inc. · 2008
- 1 generation backK100214 Cornerstone PSR Cervical Interbody Fusion DeviceMedtronic Sofamor Danek · 2010
- This deviceK110442 Nanovis Intervertebral Body Fusion SystemNanovis, LLC · 2011
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K073202 Ardis Spacerdirect predicate · 2008
Most influential descendants
Showing 5 of 10 · See all- K140280ForticoreNanovis, LLC · 2014 · cites it directly9descendants
- K161485Nanovis Intervertebral Body Fusion System and Forticore (R)Nanovis, LLC · 2016 · cites it directly5descendants
- K160874Nanovis Intervertebral Body Fusion System and FortiCore®Nanovis, LLC · 2016 · cites it directly4descendants
- K171312FortiCore®Nanovis, LLC · 2018 · 2 generations on3descendants
- K191822Nano FortiCore, FortiCoreNanovis, LLC · 2019 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −12 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −11 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −10 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −9 | K030601 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −8 | K040536 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −7 | K041556 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −6 | K043561 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −5 | K060719 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −4 | K062133 | Modification to Verte-Stack Spinal System | Medtronic Spinal and Biologics Div | 2006 | — |
| −3 | K070173 | Verte-Stack Spinal System | Medtronic Sofamor Danek, Inc. | 2007 | — |
| −2 | K073285 | Peek Prevail Cervical Interbody Device | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −1 | K100214 | Cornerstone PSR Cervical Interbody Fusion Device | Medtronic Sofamor Danek | 2010 | — |
| 0 (this device) | K110442 | Nanovis Intervertebral Body Fusion System | Nanovis, LLC | 2011 | — |
| +1 | K140280 | Forticore | Nanovis, LLC | 2014 | — |
| +1 | K161485 | Nanovis Intervertebral Body Fusion System and Forticore (R) | Nanovis, LLC | 2016 | — |
| +1 | K160874 | Nanovis Intervertebral Body Fusion System and FortiCore® | Nanovis, LLC | 2016 | — |
| +2 | K171312 | FortiCore® | Nanovis, LLC | 2018 | — |
| +1 | K191822 | Nano FortiCore, FortiCore | Nanovis, LLC | 2019 | — |
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 | 5 | 0 |
| 2003 | 6 | 0 |
| 2004 | 13 | 0 |
| 2005 | 3 | 0 |
| 2006 | 3 | 0 |
| 2007 | 7 | 0 |
| 2008 | 10 | 1 |
| 2009 | 6 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 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 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? (12)
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 |
|---|---|---|---|
| * | K091088 | LDR Spine Cervical Interbody Fusion SystemSummary page 2…were the subject of approved PMA applications and were subsequently reclassified as Class 11 devices: LDR Spine Cervical Interbody Fusion System from LDR Spine USA, K09 1088; Novel® Spinal Spacer System from Alphatec Spine, Inc., K081730; Choice Spine Cervical Interbody Spacer System from Choic… | 2009 |
| * | K081730 | Novel Cervical Spinal Spacer SystemSummary page 2…reclassified as Class 11 devices: LDR Spine Cervical Interbody Fusion System from LDR Spine USA, K09 1088; Novel® Spinal Spacer System from Alphatec Spine, Inc., K081730; Choice Spine Cervical Interbody Spacer System from Choice Spine, LP, K09153 1; CORNERSTONE" PSR Spinal System from Medtr… | 2008 |
| * | K091531 | Choice Spine Cervical Interbody Spacer System Choice Spine Cervical Interbody SpacerSummary page 2…rom LDR Spine USA, K09 1088; Novel® Spinal Spacer System from Alphatec Spine, Inc., K081730; Choice Spine Cervical Interbody Spacer System from Choice Spine, LP, K09153 1; CORNERSTONE" PSR Spinal System from Medtronic Sofamor Danek, K100214; Synthes Oracle Spacer from Synthes Spine, K072791;… | 2009 |
| * | K100214 | Cornerstone PSR Cervical Interbody Fusion DeviceSummary page 2…Spine, Inc., K081730; Choice Spine Cervical Interbody Spacer System from Choice Spine, LP, K09153 1; CORNERSTONE" PSR Spinal System from Medtronic Sofamor Danek, K100214; Synthes Oracle Spacer from Synthes Spine, K072791;… | 2010 |
| * | K072791 | Oracle Spacer, Opal SpacerSummary page 2…dy Spacer System from Choice Spine, LP, K09153 1; CORNERSTONE" PSR Spinal System from Medtronic Sofamor Danek, K100214; Synthes Oracle Spacer from Synthes Spine, K072791; Page 97 of 9S… | 2007 |
| * | K080537 | L-VarlockSummary page 3…KIO'4Z P~ 510(k) Summary Nanovis Intervertebral Body Fusion System KI 10442 L-Varlock Lumbar Cage from Kiscomedica, S.A., K080537; WAVE and LOOP Cages from Advanced Medical Technologies AG, K080401; Ardis Spacer from Abbot Spine, Inc. (now Zimmer Spine)… | 2008 |
| * | K080401 | Shell Cage, Wave Cage, Loop CageSummary page 3…ovis Intervertebral Body Fusion System KI 10442 L-Varlock Lumbar Cage from Kiscomedica, S.A., K080537; WAVE and LOOP Cages from Advanced Medical Technologies AG, K080401; Ardis Spacer from Abbot Spine, Inc. (now Zimmer Spine), K073202; Lumbar I/F Cage with VSP Spine System from DePuy AcroMed,… | 2008 |
| * | K073202 | Ardis SpacerSummary page 3…r Cage from Kiscomedica, S.A., K080537; WAVE and LOOP Cages from Advanced Medical Technologies AG, K080401; Ardis Spacer from Abbot Spine, Inc. (now Zimmer Spine), K073202; Lumbar I/F Cage with VSP Spine System from DePuy AcroMed, P960025; and Spinal USA Intervertebral Body Fusion Device from S… | 2008 |
| * | P960025 | Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle ScrewsSummary page 3…vanced Medical Technologies AG, K080401; Ardis Spacer from Abbot Spine, Inc. (now Zimmer Spine), K073202; Lumbar I/F Cage with VSP Spine System from DePuy AcroMed, P960025; and Spinal USA Intervertebral Body Fusion Device from Spinal USA, K0803 14, K081 196, and K092 193. The subject device an… | 1999 |
| * | K080314 | Spinal Usa Interbody Fusion DeviceSummary page 3…. (now Zimmer Spine), K073202; Lumbar I/F Cage with VSP Spine System from DePuy AcroMed, P960025; and Spinal USA Intervertebral Body Fusion Device from Spinal USA, K0803 14, K081 196, and K092 193. The subject device and the predicate devices have the same intended use and have the same technologi… | 2008 |
| * | K081196 | Spinal Usa VBR SystemSummary page 3…mer Spine), K073202; Lumbar I/F Cage with VSP Spine System from DePuy AcroMed, P960025; and Spinal USA Intervertebral Body Fusion Device from Spinal USA, K0803 14, K081 196, and K092 193. The subject device and the predicate devices have the same intended use and have the same technological charac… | 2008 |
| * | K092193 | Spinal Usa Interbody CagesSummary page 3…02; Lumbar I/F Cage with VSP Spine System from DePuy AcroMed, P960025; and Spinal USA Intervertebral Body Fusion Device from Spinal USA, K0803 14, K081 196, and K092 193. The subject device and the predicate devices have the same intended use and have the same technological characteristics. The su… | 2009 |
What descends from it? (10)
4 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 · Direct predicate · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 10 years and passes through 6 companies; a new generation was cleared every 9 months on median.
- 10 of the 84 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K140280 (Nanovis, LLC, 2014) has gone furthest, with 9 descendants of its own.
- 50 other devices also cite its predicate K091088.
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. 2011, 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 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 (205 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110442 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110442: Nanovis Intervertebral Body Fusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110442
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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