Cleared Traditional

K161747 - LOQTEQ® VA Distal Tibia Plate System: LOQTEQ® VA Distal Medial Tibia Plate 3.5

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

K161747 is an FDA 510(k) clearance for LOQTEQ VA Distal Tibia Plate System: LO..., 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 151-day FDA review.

K161747 · Aap Implantate AG · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K161747

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.

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 K161747.
Biomet Microfixation RibFix Blu Thoracic Fixation System
K162974 · Biomet Microfixation · Dec 2016
aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5
K161696 · Aap Implantate AG · Nov 2016
Biomet Microfixation SternaLock 360 Sternal Closure System
K163007 · Biomet Microfixation · 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