Cleared Traditional

K260277 - MIKRON TRAUMA BONE PLATE& SCREW SYSTEM

K260277 is an FDA 510(k) clearance for MIKRON TRAUMA BONE PLATE& SCREW SYSTEM, manufactured by Mikron Makina San. ve Tic. Ltd. Sti.. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 196-day FDA review.

K260277 · Mikron Makina San. ve Tic. Ltd. Sti. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Aug 2026
Decision
196d
Days
Class 2
Risk

K260277 is an FDA 510(k) clearance for the MIKRON TRAUMA BONE PLATE& SCREW SYSTEM. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Mikron Makina San. ve Tic. Ltd. Sti. (Yenimahalle, TR). The FDA issued a Cleared decision on August 13, 2026 after a review of 196 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Mikron Makina San. ve Tic. Ltd. Sti. devices

FDA 510(k) Submission Details - K260277

510(k) Number K260277 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 2026
Decision Date August 13, 2026
Days to Decision 196 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
74d slower than avg
Panel avg: 122d · This submission: 196d
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 K260277.
FRAXION 3.5 Plate System (Various - See Catalog)
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