Cleared Traditional

K123347 - NORMED ANKLE FIX SYSTEM 4.0 AND NORMED ...

K123347 is an FDA 510(k) clearance for NORMED ANKLE FIX SYSTEM 4.0 AND NORMED ..., manufactured by Normed Medizin-Technik GmbH. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 275-day FDA review.

K123347 · Normed Medizin-Technik GmbH · Orthopedic device
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Aug 2013
Decision
275d
Days
Class 2
Risk

K123347 is an FDA 510(k) clearance for the NORMED ANKLE FIX SYSTEM 4.0 AND NORMED ANKLE FIX PLUS SYSTEM 4.0. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Normed Medizin-Technik GmbH (Austin, US). The FDA issued a Cleared decision on August 2, 2013 after a review of 275 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 Normed Medizin-Technik GmbH devices

FDA 510(k) Submission Details - K123347

510(k) Number K123347 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 2012
Decision Date August 02, 2013
Days to Decision 275 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
153d slower than avg
Panel avg: 122d · This submission: 275d
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 1044
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K123347.
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