Cleared Traditional

K172213 - MECRON Cannulated Screw System (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K172213 · Merete GmbH · Orthopedic device
Oct 2017
Decision
91d
Days
Class 2
Risk

K172213 is an FDA 510(k) clearance for the MECRON Cannulated Screw System. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Merete GmbH (Berlin, DE). The FDA issued a Cleared decision on October 23, 2017 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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.

Submission Details

510(k) Number K172213 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 2017
Decision Date October 23, 2017
Days to Decision 91 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 116d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HWC Screw, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 - HWC Screw, Fixation, Bone

All 45
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K172213.
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K250536 · Extremity Medical, LLC · Oct 2025