510(k) · Cleared
ClearedNano FortiCore, FortiCore
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 Oct 11, 2019 as substantially equivalent to K171312 (Nanovis, LLC, 2018) and 7 other predicates after a 95-day review. Its family tree reaches back 21 generations to 1984. 1 of the 242 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it.
- Decided
- Oct 11, 2019
- Review
- 95 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 21 generations to K841189 (1984). 239 ancestors in all, the oldest K792352 (1979). 2 later devices descend from it, 2 citing it directly. 1 of the 242 devices in this family, counting this one, has a Class I recall.
- Root · 21 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 17 generations between
- 3 generations backK152304 Tritanium PL CageStryker · 2015 · Recalled
- 2 generations backK160125 Cascadia Interbody SystemK2m · 2016
- 1 generation backK171312 FortiCore®Nanovis, LLC · 2018
- This deviceK191822 Nano FortiCore, FortiCoreNanovis, LLC · 2019
- Descendant · cites it directly · 0 of its ownK241605 Adaptix™ PEEK Interbody System with Nanotechnology; Capstone…Nanovis, LLC · 2024
- Descendant · cites it directly · 0 of its ownK230936 Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC · 2023
Show all 21 generations
- Root · 21 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 20 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 19 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 18 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 17 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 16 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 15 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 14 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 13 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 12 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 11 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 10 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 9 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 8 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 7 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 6 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 5 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 4 generations backK143616 AccuLIF TL and PL CageStryker Corporation · 2015 · Recalled
- 3 generations backK152304 Tritanium PL CageStryker · 2015 · Recalled
- 2 generations backK160125 Cascadia Interbody SystemK2m · 2016
- 1 generation backK171312 FortiCore®Nanovis, LLC · 2018
- This deviceK191822 Nano FortiCore, FortiCoreNanovis, LLC · 2019
Class I recalls in this family
- K073202 Ardis Spacer2 generations back · 2008
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 |
|---|---|---|---|---|---|
| −21 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −20 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −19 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −18 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −17 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −16 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −15 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −14 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −13 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −12 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −11 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −10 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −9 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −8 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −7 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −6 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −5 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −4 | K143616 | AccuLIF TL and PL Cage | Stryker Corporation | 2015 | 4 |
| −3 | K152304 | Tritanium PL Cage | Stryker | 2015 | 1 |
| −2 | K160125 | Cascadia Interbody System | K2m | 2016 | — |
| −1 | K171312 | FortiCore® | Nanovis, LLC | 2018 | — |
| 0 (this device) | K191822 | Nano FortiCore, FortiCore | Nanovis, LLC | 2019 | — |
| +1 | K241605 | Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK… | Nanovis, LLC | 2024 | — |
| +1 | K230936 | Anatomic PEEK™ Cervical Fusion System with Nanotechnology | Nanovis, LLC | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 10 | 0 |
| 2002 | 8 | 0 |
| 2003 | 14 | 0 |
| 2004 | 24 | 0 |
| 2005 | 15 | 0 |
| 2006 | 7 | 0 |
| 2007 | 13 | 0 |
| 2008 | 38 | 1 |
| 2009 | 23 | 0 |
| 2010 | 11 | 0 |
| 2011 | 16 | 0 |
| 2012 | 9 | 0 |
| 2013 | 5 | 0 |
| 2014 | 10 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (8)
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 |
|---|---|---|---|
| * | K171312 | FortiCore®Summary page 6…to the nanotubes. Marker pins in the lumbar devices are manufactured from tantalum per ASTM F560. Primary FortiCore® (Nanovis LLC, K171312) predicate: Additional FortiCore® & Nanovis Interbody (Nanovis LLC, K140280, K160874 & K161485, predicates: K11044… | 2018 |
| * | K140280 | ForticoreSummary page 6…ured from tantalum per ASTM F560. Primary FortiCore® (Nanovis LLC, K171312) predicate: Additional FortiCore® & Nanovis Interbody (Nanovis LLC, K140280, K160874 & K161485, predicates: K110442), ALTA Anterior Cervical Interbody Spacer (Astura Medical, K173… | 2014 |
| * | K160874 | Nanovis Intervertebral Body Fusion System and FortiCore®Summary page 6…tantalum per ASTM F560. Primary FortiCore® (Nanovis LLC, K171312) predicate: Additional FortiCore® & Nanovis Interbody (Nanovis LLC, K140280, K160874 & K161485, predicates: K110442), ALTA Anterior Cervical Interbody Spacer (Astura Medical, K173324), MC+… | 2016 |
| * | K161485 | Nanovis Intervertebral Body Fusion System and Forticore (R)Summary page 6…per ASTM F560. Primary FortiCore® (Nanovis LLC, K171312) predicate: Additional FortiCore® & Nanovis Interbody (Nanovis LLC, K140280, K160874 & K161485, predicates: K110442), ALTA Anterior Cervical Interbody Spacer (Astura Medical, K173324), MC+ (LDR Hold… | 2016 |
| * | K110442 | Nanovis Intervertebral Body Fusion SystemSummary page 6…FortiCore® (Nanovis LLC, K171312) predicate: Additional FortiCore® & Nanovis Interbody (Nanovis LLC, K140280, K160874 & K161485, predicates: K110442), ALTA Anterior Cervical Interbody Spacer (Astura Medical, K173324), MC+ (LDR Holding, K091088), Lumbar I/F Ca… | 2011 |
| * | K173324 | ALTA Anterior Cervical Interbody SpacerSummary page 6…e® & Nanovis Interbody (Nanovis LLC, K140280, K160874 & K161485, predicates: K110442), ALTA Anterior Cervical Interbody Spacer (Astura Medical, K173324), MC+ (LDR Holding, K091088), Lumbar I/F Cage® (DePuy AcroMed, Inc., P960025) Performance Mechanical te… | 2018 |
| * | K091088 | LDR Spine Cervical Interbody Fusion SystemSummary page 6…vis LLC, K140280, K160874 & K161485, predicates: K110442), ALTA Anterior Cervical Interbody Spacer (Astura Medical, K173324), MC+ (LDR Holding, K091088), Lumbar I/F Cage® (DePuy AcroMed, Inc., P960025) Performance Mechanical testing of the worst case Fort… | 2009 |
| * | P960025 | Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle ScrewsSummary page 6…TA Anterior Cervical Interbody Spacer (Astura Medical, K173324), MC+ (LDR Holding, K091088), Lumbar I/F Cage® (DePuy AcroMed, Inc., P960025) Performance Mechanical testing of the worst case FortiCore® and Nano FortiCore® devices Data: was performed… | 1999 |
What descends from it? (2)
2 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 35 years and passes through 14 companies; a new generation was cleared every 10 months on median.
- 27 of the 239 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K241605 (Nanovis, LLC, 2024) has gone furthest, with 0 descendants of its own.
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. 2019, 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?
FortiCore® cervical devices are intended for anterior cervical spinal fusion procedures in skeletally mature patients for the treatment of cervical disc degeneration and/or cervical spinal instability as confirmed by imaging studies (radiographs, CT, MRI) that results in radiculopathy, myelopathy and/or pain at multiple contiguous levels from C2-T1. These patients should have had at least six weeks of nonoperative treatment. FortiCore® cervical devices…
Read the full statement (314 words)
FortiCore® cervical devices are intended for anterior cervical spinal fusion procedures in skeletally mature patients for the treatment of cervical disc degeneration and/or cervical spinal instability as confirmed by imaging studies (radiographs, CT, MRI) that results in radiculopathy, myelopathy and/or pain at multiple contiguous levels from C2-T1. These patients should have had at least six weeks of nonoperative treatment. FortiCore® cervical devices are to be used with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and in combination with supplemental fixation indicated for cervical fusion procedures.
Nano FortiCore® cervical devices are intended for anterior cervical spinal fusion procedures in skeletally mature patients for the treatment of cervical disc degeneration and/or cervical spinal instability as confirmed by imaging studies (radiographs, CT, MRI) that results in radiculopathy, myelopathy and/or pain at multiple contiguous levels from C2-T1. These patients should have had at least six weeks of non-operative treatment. Nano FortiCore® cervical devices are to be used with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and in combination with supplemental fixation indicated for cervical fusion procedures.
Nano FortiCore® lumbar devices are 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). Additionally, Nano FortiCore® lumbar devices can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. Nano FortiCore® lumbar devices are to be used with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and with supplemental fixation indicated for lumbar spinal fusion procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191822 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191822: Nano FortiCore, FortiCore.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191822
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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