510(k) · Cleared

Cleared

FRAXION Spinal Fixation System

K262091510(k) TraditionalCleared Sep 17, 202687-day reviewClass II21 CFR 888.3070

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Ortler Global Tibbi Gerecler Anonim Sirketi · NKB Thoracolumbosacral Pedicle Screw System

Cleared on Sep 17, 2026 as substantially equivalent to K212220 (Artfx Medical, LLC, 2023) after an 87-day review. Its family tree reaches back 1 generation to 2023.

Decided: Sep 17, 2026
Review: 87 days
Class: Class II
Product code: NKB
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K212220 (2023). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK212220 ArtFX Spinal Fixation SystemArtfx Medical, LLC · 2023
This deviceK262091 FRAXION Spinal Fixation SystemOrtler Global Tibbi Gerecler Anonim Sirketi · 2026

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K212220	ArtFX Spinal Fixation System	Artfx Medical, LLC	2023	—
0 (this device)	K262091	FRAXION Spinal Fixation System	Ortler Global Tibbi Gerecler Anonim Sirketi	2026	—

FIG. 1 — Lineage of K262091, 2023–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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What was it cleared against? (1)

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	Applicant	Decided	Recalls
*	K212220	ArtFX Spinal Fixation System Summary page 5 …Product Code(s) NKB, KWP, KWQ I Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K212220 ArtFX Spinal Fixation System NKB Device Description Summary 21 CFR 807.92(a)(4) The FRAXION Spinal Fixation System is a top-load…	Artfx Medical, LLC	2023	—

Also cleared against K212220: 1 other device →

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?

Its one ancestor has no recall.
1 other device also cites its predicate K212220.

How does its category compare?

All NKB devices

NKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.

FDA decisions per year · NKB

24in 2025

2007high 63 (2017) · low 24 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NKB

61in 2025

2007high 111 (2010) · low 57 (2024)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · NKB

1in 2025

2007high 33 (2009) · low 0 (2013)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · NKB

1,171in 2025

2007high 2,076 (2020) · low 34 (2007)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?

FRAXION SPINAL FIXATION SYSTEM is intended for use in the non-cervical spine. When used as an anterior/anterolateral and posterior, non-cervical pedicle and non-pedicle fixation system, the FRAXION SPINAL FIXATION SYSTEM is intended to provide additional support during fusion using autograft or allograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities: * Degenerative disc disease (DDD)…

Read the full statement (108 words)

FRAXION SPINAL FIXATION SYSTEM is intended for use in the non-cervical spine. When used as an anterior/anterolateral and posterior, non-cervical pedicle and non-pedicle fixation system,

the FRAXION SPINAL FIXATION SYSTEM is intended to provide additional support during fusion 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 discogenic origin with degeneration of the disc confirmed by history and radiographic studies;

* Spondylolisthesis;

* Trauma, including fracture or dislocation;

* Spinal stenosis;

* Curvatures, including scoliosis, kyphosis, and/or lordosis;

* Tumor;

* Pseudoarthrosis; and

* Failed previous fusion.

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/K262091 · printed Nov 6, 2026

Cite this page

510(k) Report. “K262091: FRAXION 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/K262091

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Record history

FDA decision record loaded Oct 30, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026