Cleared Traditional

K161747 - LOQTEQ VA Distal Tibia Plate System: LO...

Also marketed or referenced as:
LOQTEQ® VA Distal Anterolateral Tibia Plate 3.5 LOQTEQ® VA Distal Fibula Plate 2.7/3.5

K161747 is the FDA 510(k) clearance for LOQTEQ VA Distal Tibia Plate System: LO... by Aap Implantate AG. It is a Class 2 Orthopedic device (product code HRS) cleared through the Traditional 510(k) pathway after a 151-day FDA review.

K161747 · Aap Implantate AG · Orthopedic device
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Nov 2016
Decision
151d
Days
Class 2
Risk

K161747 is an FDA 510(k) clearance for the LOQTEQ® VA Distal Tibia Plate System: LOQTEQ® VA Distal Medial Tibia Plate 3.5. 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 November 22, 2016 after a review of 151 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 Aap Implantate AG devices

Submission Details

510(k) Number K161747 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 2016
Decision Date November 22, 2016
Days to Decision 151 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
29d slower than avg
Panel avg: 122d · This submission: 151d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 902
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K161747.
VLP MINI-MOD 2.0mm Column Plates
K163086 · Smith & Nephew, Inc. · Dec 2016
Medline UNITE® Ankle Fracture Plating System
K162829 · Medline Industries, Inc. · Dec 2016
aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5
K161696 · Aap Implantate AG · Nov 2016
EVOS Small Fragment Plating System
K162078 · Smith & Nephew, Inc. · Nov 2016
VLP Wrist Fracture System
K161665 · Smith & Nephew, Inc. · Nov 2016
LOQTEQ Distal Fibula Plate 3.5, Cancellous Screw 4.0, Washer
K161703 · Aap Implantate AG · Nov 2016