510(k) · Cleared
ClearedFortiCore®
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 Jan 22, 2018 as substantially equivalent to K161485 (Nanovis, LLC, 2016) and 4 other predicates after a 263-day review. Its family tree reaches back 20 generations to 1984. 1 of the 221 devices in its family, counting itself, has a Class I recall. 3 later devices descend from it.
- Decided
- Jan 22, 2018
- Review
- 263 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 20 generations to K841189 (1984). 217 ancestors in all, the oldest K792352 (1979). 3 later devices descend from it, 1 citing it directly. 1 of the 221 devices in this family, counting this one, has a Class I recall.
- Root · 20 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 16 generations between
- 3 generations backK143616 AccuLIF TL and PL CageStryker Corporation · 2015 · Recalled
- 2 generations backK152304 Tritanium PL CageStryker · 2015 · Recalled
- 1 generation backK160125 Cascadia Interbody SystemK2m · 2016
- This deviceK171312 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
Show all 20 generations
- Root · 20 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 19 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 18 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 17 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 16 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 15 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 14 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 13 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 12 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 11 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 10 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 9 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 8 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 7 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 6 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 5 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 4 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 3 generations backK143616 AccuLIF TL and PL CageStryker Corporation · 2015 · Recalled
- 2 generations backK152304 Tritanium PL CageStryker · 2015 · Recalled
- 1 generation backK160125 Cascadia Interbody SystemK2m · 2016
- This deviceK171312 FortiCore®Nanovis, LLC · 2018
Class I recalls in this family
- K073202 Ardis Spacer3 generations back · 2008
Most influential descendants
Showing 3 of 3 · See all- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −20 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −19 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −18 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −17 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −16 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −15 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −14 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −13 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −12 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −11 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −10 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −9 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −8 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −7 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −6 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −5 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −4 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −3 | K143616 | AccuLIF TL and PL Cage | Stryker Corporation | 2015 | 4 |
| −2 | K152304 | Tritanium PL Cage | Stryker | 2015 | 1 |
| −1 | K160125 | Cascadia Interbody System | K2m | 2016 | — |
| 0 (this device) | 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 | — |
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 | 13 | 0 |
| 2004 | 20 | 0 |
| 2005 | 9 | 0 |
| 2006 | 6 | 0 |
| 2007 | 13 | 0 |
| 2008 | 36 | 1 |
| 2009 | 22 | 0 |
| 2010 | 10 | 0 |
| 2011 | 16 | 0 |
| 2012 | 8 | 0 |
| 2013 | 5 | 0 |
| 2014 | 9 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (5)
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 |
|---|---|---|---|
| * | K161485 | Nanovis Intervertebral Body Fusion System and Forticore (R)Summary page 4…Medical) is manufactured from CP titanium as described by ASTM F67. ® Primary Predicate: FortiCore (Nanovis LLC, K161485) ® Additional predicates: FortiCore (Nanovis LLC, K140280 & K160874), Lumbar I/F Cage® (DeP… | 2016 |
| * | K140280 | ForticoreSummary page 4…® Primary Predicate: FortiCore (Nanovis LLC, K161485) ® Additional predicates: FortiCore (Nanovis LLC, K140280 & K160874), Lumbar I/F Cage® (DePuy AcroMed, Inc. – P960025), Cascadia Interbody System (K2M, Inc. –… | 2014 |
| * | K160874 | Nanovis Intervertebral Body Fusion System and FortiCore®Summary page 4…® Primary Predicate: FortiCore (Nanovis LLC, K161485) ® Additional predicates: FortiCore (Nanovis LLC, K140280 & K160874), Lumbar I/F Cage® (DePuy AcroMed, Inc. – P960025), Cascadia Interbody System (K2M, Inc. –… | 2016 |
| * | P960025 | Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle ScrewsSummary page 4…® Additional predicates: FortiCore (Nanovis LLC, K140280 & K160874), Lumbar I/F Cage® (DePuy AcroMed, Inc. – P960025), Cascadia Interbody System (K2M, Inc. – K160125).… | 1999 |
| * | K160125 | Cascadia Interbody SystemSummary page 4…novis LLC, K140280 & K160874), Lumbar I/F Cage® (DePuy AcroMed, Inc. – P960025), Cascadia Interbody System (K2M, Inc. – K160125). ® Performance Data: Mechanical testing of the… | 2016 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K191822 | Nano FortiCore, FortiCore | 2019 | 2 |
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 · 3 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 34 years and passes through 14 companies; a new generation was cleared every 10 months on median.
- 26 of the 217 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K191822 (Nanovis, LLC, 2019) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K161485.
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. 2018, 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?
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…
Read the full statement (118 words)
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). Additionally, FortiCore® can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. FortiCore® 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K171312 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171312: FortiCore®.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171312
Report an extraction error
Are you the manufacturer?
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