Cleared Traditional

K261830 - FRAXION 3.5 Plate System (Various - See Catalog)

Also marketed or referenced as:
FRAXION 4.5 Plate System (Various - See Catalog) FRAXION Mini Plate System (Various - See Catalog) FRAXION Bone Screw System (Various - See Catalog)

K261830 is an FDA 510(k) clearance for FRAXION 3.5 Plate System (Various - See..., manufactured by Ortler Global Tibbi Gerecler Anonim Sirketi. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K261830 · Ortler Global Tibbi Gerecler Anonim Sirketi · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2026
Decision
87d
Days
Class 2
Risk

K261830 is an FDA 510(k) clearance for the FRAXION 3.5 Plate System (Various - See Catalog). Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Ortler Global Tibbi Gerecler Anonim Sirketi (Ankara, TR). The FDA issued a Cleared decision on August 28, 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 888.3030 - 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 - K261830

510(k) Number K261830 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 2026
Decision Date August 28, 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.

HRS Device Classification - Class 2, Special Controls

Product Code HRS Plate, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - HRS Plate, Fixation, Bone

All 1073
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K261830.
Versalock Sterile Plating System
K262537 · GM Dos Reis Industria e Comercio Ltda. · Aug 2026
MIKRON TRAUMA BONE PLATE& SCREW SYSTEM
K260277 · Mikron Makina San. ve Tic. Ltd. Sti. · Aug 2026
Xpert Ankle
K261511 · Newclip Technics · Jul 2026
Versalock Proximal Tibial Plating System
K261406 · GM Dos Reis Industria e Comercio Ltda. · Jul 2026
TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD)
K262032 · TriMed, Inc. · Jul 2026
Alians Elbow S
K261191 · Newclip Technics · Jul 2026