510(k) · Cleared
ClearedNano FortiFix® System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nanovis, LLC · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Dec 22, 2020 as substantially equivalent to K193211 (Nanovis Spine, LLC, 2020) and 2 other predicates after a 29-day review. Its family tree reaches back 17 generations to 1985.
- Decided
- Dec 22, 2020
- Review
- 29 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 17 generations to K853033 (1985). 240 ancestors in all, the oldest K841189 (1984). No later device cites it as a predicate yet.
- Root · 17 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 13 generations between
- 3 generations backK131250 Tiger Spine SystemCorelink, LLC · 2013
- 2 generations backK133369 Tiger Spine SystemCorelink, LLC · 2014
- 1 generation backK193211 Nano FortiFix® SystemNanovis Spine, LLC · 2020
- This deviceK203452 Nano FortiFix® SystemNanovis, LLC · 2020
Show all 17 generations
- Root · 17 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 16 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 15 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 14 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 13 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 12 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 11 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 10 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 9 generations backK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 8 generations backK063156 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 7 generations backK063741 Expedium Spine SystemDepuy Spine, Inc. · 2007
- 6 generations backK080313 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2008
- 5 generations backK111571 Viper SystemsJohnson & Johnson · 2011
- 4 generations backK120696 Tiger Spine SystemCorelink, LLC · 2012
- 3 generations backK131250 Tiger Spine SystemCorelink, LLC · 2013
- 2 generations backK133369 Tiger Spine SystemCorelink, LLC · 2014
- 1 generation backK193211 Nano FortiFix® SystemNanovis Spine, LLC · 2020
- This deviceK203452 Nano FortiFix® SystemNanovis, LLC · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −16 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −15 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −14 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −13 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −12 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −11 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −10 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −9 | K062174 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −8 | K063156 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −7 | K063741 | Expedium Spine System | Depuy Spine, Inc. | 2007 | — |
| −6 | K080313 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2008 | — |
| −5 | K111571 | Viper Systems | Johnson & Johnson | 2011 | — |
| −4 | K120696 | Tiger Spine System | Corelink, LLC | 2012 | — |
| −3 | K131250 | Tiger Spine System | Corelink, LLC | 2013 | — |
| −2 | K133369 | Tiger Spine System | Corelink, LLC | 2014 | — |
| −1 | K193211 | Nano FortiFix® System | Nanovis Spine, LLC | 2020 | — |
| 0 (this device) | K203452 | Nano FortiFix® System | Nanovis, LLC | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1990 | 2 | 0 |
| 1992 | 5 | 0 |
| 1993 | 3 | 0 |
| 1994 | 3 | 0 |
| 1995 | 8 | 0 |
| 1996 | 7 | 0 |
| 1997 | 8 | 0 |
| 1998 | 15 | 0 |
| 1999 | 15 | 0 |
| 2000 | 19 | 0 |
| 2001 | 19 | 0 |
| 2002 | 13 | 0 |
| 2003 | 12 | 0 |
| 2004 | 23 | 0 |
| 2005 | 18 | 0 |
| 2006 | 10 | 0 |
| 2007 | 9 | 0 |
| 2008 | 7 | 0 |
| 2009 | 8 | 0 |
| 2010 | 11 | 0 |
| 2011 | 3 | 0 |
| 2012 | 3 | 0 |
| 2018 | 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 NKB? 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 NKB device
- #1 K223494 CD Horizon Spinal Systemscore 40.4 · 30 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 |
|---|---|---|---|
| * | K193211 | Nano FortiFix® SystemSummary page 4…ed from cobalt chrome (ASTM F1537). ® Primary Predicate: Nano FortiFix System (Nanovis Spine, LLC – K193211) Additional Predicates: Nanovis Spinal System (Nanovis LLC – K113173) Altus Spine Pedicle Screw System… | 2020 |
| * | K113173 | Nanovis Spinal SystemSummary page 4…® Primary Predicate: Nano FortiFix System (Nanovis Spine, LLC – K193211) Additional Predicates: Nanovis Spinal System (Nanovis LLC – K113173) Altus Spine Pedicle Screw System (Altus Partners, LLC – K181339)… | 2012 |
| * | K181339 | Altus Spine Pedicle Screw SystemSummary page 4…e, LLC – K193211) Additional Predicates: Nanovis Spinal System (Nanovis LLC – K113173) Altus Spine Pedicle Screw System (Altus Partners, LLC – K181339) K203452… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
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 35 years and passes through 9 companies; a new generation was cleared every 1.3 years on median.
- 15 of the 240 ancestors have a recall of any class.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · NKB
24in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NKB
61in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NKB
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · NKB
1,171in 2025
MAUDE reports naming product code NKB, 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 | 38 | 87 | 4 | 34 |
| 2008 | 36 | 59 | 5 | 82 |
| 2009 | 44 | 71 | 33 | 171 |
| 2010 | 37 | 111 | 4 | 462 |
| 2011 | 48 | 84 | 3 | 577 |
| 2012 | 60 | 79 | 13 | 1,747 |
| 2013 | 35 | 73 | 0 | 1,962 |
| 2014 | 46 | 90 | 3 (1) | 1,671 |
| 2015 | 55 | 90 | 3 | 1,446 |
| 2016 | 50 | 84 | 1 | 1,585 |
| 2017 | 63 | 69 | 1 | 1,618 |
| 2018 | 56 | 61 | 3 | 1,684 |
| 2019 | 39 | 84 | 1 | 1,915 |
| 2020 | 48 | 68 | 1 | 2,076 |
| 2021 | 32 | 61 | 0 | 1,745 |
| 2022 | 34 | 88 | 5 | 1,339 |
| 2023 | 44 | 72 | 2 | 919 |
| 2024 | 39 | 57 | 3 | 1,614 |
| 2025 | 24 | 61 | 1 | 1,171 |
| 2026 | 30 | 91 | 3 | — |
What is it indicated for?
The Nano FortiFix® System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the non-cervical spine for the following indications: degenerative disc disease, spinal stenosis, spondylolisthesis, spinal deformities (i.e., scoliosis, kyphosis, and/ or lordosis), trauma (i.e., fracture or dislocation), tumor, pseudarthrosis and/or failed previous fusion. The Nano FortiFix® System can be used in an open approach or a percutaneous approach with MIS instrumentation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K203452 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203452: Nano FortiFix® System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203452
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