510(k) · Cleared
ClearedArtFX Spinal Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Artfx Medical, LLC · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Apr 20, 2023 after a 643-day review. The FDA summary names its predicate without a number. 5 later devices descend from it.
- Decided
- Apr 20, 2023
- Review
- 643 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK212220 ArtFX Spinal Fixation SystemArtfx Medical, LLC · 2023
- Descendant · cites it directly · 3 of its ownK241657 MSFX Mikron Spinal Fixation SystemMikron Makina Sanayi VE Ticaret Ltd. Sti. · 2024
- Descendant · 2 generations on · 1 of its ownK243946 EffortMed Spinal Fixation SystemEffortmed, LLC · 2025
- Descendant · cites it directly · 0 of its ownK262091 FRAXION Spinal Fixation SystemOrtler Global Tibbi Gerecler Anonim Sirketi · 2026
- Descendant · 3 generations on · 0 of its ownK254247 Osteomni Spinal Fixation SystemOsteomni, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK250092 HC Biologics Osteopoint Spinal Fixation SystemHC Biologics, LLC · 2025
Most influential descendants
Showing 5 of 5 · See all- K241657MSFX Mikron Spinal Fixation SystemMikron Makina Sanayi VE Ticaret Ltd. Sti. · 2024 · cites it directly3descendants
- K243946EffortMed Spinal Fixation SystemEffortmed, LLC · 2025 · 2 generations on1descendant
- K262091FRAXION Spinal Fixation SystemOrtler Global Tibbi Gerecler Anonim Sirketi · 2026 · cites it directly0descendants
- K254247Osteomni Spinal Fixation SystemOsteomni, Inc. · 2026 · 3 generations on0descendants
- K250092HC Biologics Osteopoint Spinal Fixation SystemHC Biologics, LLC · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K212220 | ArtFX Spinal Fixation System | Artfx Medical, LLC | 2023 | — |
| +1 | K241657 | MSFX Mikron Spinal Fixation System | Mikron Makina Sanayi VE Ticaret Ltd. Sti. | 2024 | — |
| +2 | K243946 | EffortMed Spinal Fixation System | Effortmed, LLC | 2025 | — |
| +1 | K262091 | FRAXION Spinal Fixation System | Ortler Global Tibbi Gerecler Anonim Sirketi | 2026 | — |
| +3 | K254247 | Osteomni Spinal Fixation System | Osteomni, Inc. | 2026 | — |
| +2 | K250092 | HC Biologics Osteopoint Spinal Fixation System | HC Biologics, LLC | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 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? (4)
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 |
|---|---|---|---|
| * | — | Mikron Spinal Fixation System Named without a submission number | |
| * | — | CD HORIZON Spinal System Named without a submission number | |
| * | — | USS Small Stature Named without a submission number | |
| * | — | VIA Spinal System Named without a submission number |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K241657 (Mikron Makina Sanayi VE Ticaret Ltd. Sti., 2024) has gone furthest, with 3 descendants of its own.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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?
ARTFX SPINAL FIX/\ TTON SYSTEM is intended for use in the noncervical spine. When used as an anterior/anterolateral and posterior, noncervical pedicle and non-pedicle fixation system, the ARTFX SPINAL FIXATION SYSTEM is intended to provide additional support during fusian using autograft or allograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities: -Degenerative disc disease (DDD) (defined as…
Read the full statement (104 words)
ARTFX SPINAL FIX/\ TTON SYSTEM is intended for use in the noncervical spine. When used as an anterior/anterolateral and posterior, noncervical pedicle and non-pedicle fixation system, the ARTFX SPINAL FIXATION SYSTEM is intended to provide additional support during fusian using autograft or allograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities:
-Degenerative disc disease (DDD) (defined as back pain of discogenie origin with degeneration of the disc confirmed by history and radiographic studies);
-Spondylolisthesis;
- Trauma (i.e. f racture or dislocation);
-Spinal stenosis;
-Curvatures (i.e. scoliosis, kyphosis, and/or lordosis)
- Tumor:
-Pseudoarthrosis; and Failed previous fusion
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212220 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212220: ArtFX Spinal Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212220
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