Cleared Traditional

K153034 - aap LOQTEQ VA Radius Set 2.5

K153034 is an FDA 510(k) clearance for aap LOQTEQ VA Radius Set 2.5, manufactured by Aap Implantate AG. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K153034 · Aap Implantate AG · Orthopedic device
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Jan 2016
Decision
94d
Days
Class 2
Risk

K153034 is an FDA 510(k) clearance for the aap LOQTEQ VA Radius Set 2.5. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Aap Implantate AG (Berlin, DE). The FDA issued a Cleared decision on January 21, 2016 after a review of 94 days - within the typical 510(k) review window.

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 Aap Implantate AG devices

FDA 510(k) Submission Details - K153034

510(k) Number K153034 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 2015
Decision Date January 21, 2016
Days to Decision 94 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
28d faster than avg
Panel avg: 122d · This submission: 94d
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 1222
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K153034.
Epic Extremity Plate System
K153340 · Epic Extremity, LLC · Feb 2016
TriMed Humeral Supracondylar Fixation System
K151735 · TriMed, Inc. · Jan 2016
Cable-Ready Cable Grip System: Cable-Ready Bone Plate System
K151716 · Zimmer, Inc. · Jan 2016
ARIX Wrist System
K151468 · Jeil Medical Corporation · Jan 2016
Treace Medical Concepts (TMC) Plating System
K153531 · Treace Medical Concepts, Inc. · Jan 2016
OsteoMed ExtremiLOCK Wrist Plating System
K152145 · Osteomed · Dec 2015