Cleared Traditional

K262091 - FRAXION Spinal Fixation System

K262091 is an FDA 510(k) clearance for FRAXION Spinal Fixation System, manufactured by Ortler Global Tibbi Gerecler Anonim Sirketi. The device is a Class 2 Orthopedic device with product code NKB cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K262091 · Ortler Global Tibbi Gerecler Anonim Sirketi · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2026
Decision
87d
Days
Class 2
Risk

K262091 is an FDA 510(k) clearance for the FRAXION Spinal Fixation System. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Ortler Global Tibbi Gerecler Anonim Sirketi (Ankara, TR). The FDA issued a Cleared decision on September 17, 2026 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ortler Global Tibbi Gerecler Anonim Sirketi devices

FDA 510(k) Submission Details - K262091

510(k) Number K262091 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 2026
Decision Date September 17, 2026
Days to Decision 87 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 122d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NKB Device Classification - Class 2, Special Controls

Product Code NKB Thoracolumbosacral Pedicle Screw System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
Definition Intended To Provide Immobilization And Stabilization Of Spinal Segments In Thoracic, Lumbar, And Sacral Spine As An Adjunct To Fusion.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - NKB Thoracolumbosacral Pedicle Screw System

All 913
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K262091.
SAS MIS Pelvic Incidence Rods
K263172 · Spinal Alignment Solutions, Inc. · Sep 2026
Kentrospine Viktr-MIS® Pedicle screw system
K252139 · Rivarp Medical Pvt., Ltd. · Sep 2026
iFuse Granite Onyx™ Implant System
K262067 · SI-BONE, Inc. · Sep 2026
RIVA® Posterior Fixation System with NanoACTIV Surface Technology
K262193 · Xenix Medical · Sep 2026
KHEIRON® Spinal Fixation System, including patient specific K-ROD
K262828 · S.M.A.I.O · Sep 2026
Tiger 2 System
K253943 · Zavation Medical Products, LLC · Jul 2026