Cleared Traditional

K262126 - Cerclage Wires

Also marketed or referenced as:
K-wires Steinmann Pins

K262126 is an FDA 510(k) clearance for Cerclage Wires, manufactured by MK Medical GmbH. The device is a Class 2 Orthopedic device with product code HTY cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K262126 · MK Medical GmbH · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
120d
Days
Class 2
Risk

K262126 is an FDA 510(k) clearance for the Cerclage Wires. Classified as Pin, Fixation, Smooth (product code HTY), Class II - Special Controls.

Submitted by MK Medical GmbH (Emmingen-Liptingen, DE). The FDA issued a Cleared decision on October 22, 2026 after a review of 120 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.

FDA 510(k) Submission Details - K262126

510(k) Number K262126 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 2026
Decision Date October 22, 2026
Days to Decision 120 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
2d faster than avg
Panel avg: 122d · This submission: 120d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HTY Device Classification - Class 2, Special Controls

Product Code HTY Pin, Fixation, Smooth
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 Consultant

Medagent GmbH
Anaga Nayak

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HTY Pin, Fixation, Smooth

All 205
Devices cleared under the same product code (HTY) and FDA review panel - the closest regulatory comparables to K262126.
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K250646 · Nvision Biomedical Technologies · Jun 2025
K262126 · Cerclage Wires
Download PDF FDA Summary MK Medical GmbH