Cleared Traditional

K071852 - AAP APS SYSTEM

K071852 is an FDA 510(k) clearance for AAP APS SYSTEM, manufactured by Aap Implantate AG. The device is a Class 2 Orthopedic device with product code KTT cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K071852 · Aap Implantate AG · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2007
Decision
55d
Days
Class 2
Risk

K071852 is an FDA 510(k) clearance for the AAP APS SYSTEM. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (product code KTT), Class II - Special Controls.

Submitted by Aap Implantate AG (Berlin, DE). The FDA issued a Cleared decision on August 29, 2007 after a review of 55 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Aap Implantate AG devices

FDA 510(k) Submission Details - K071852

510(k) Number K071852 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 2007
Decision Date August 29, 2007
Days to Decision 55 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
67d faster than avg
Panel avg: 122d · This submission: 55d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KTT Device Classification - Class 2, Special Controls

Product Code KTT Appliance, Fixation, Nail/blade/plate Combination, Multiple Component
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 - KTT Appliance, Fixation, Nail/blade/plate Combination, Multiple Component

All 371
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K071852.
VARIAX ELBOW SYSTEM
K073527 · Howmedica Osteonics Corp. · Feb 2008
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K080071 · Wrightmedicaltechnologyinc · Feb 2008
SUPERCABLE GRIP AND PLATE SYSTEM
K072250 · Kinamed, Inc. · Nov 2007
BIOMET VISION FOOTRING SYSTEM
K071395 · Biomet Manufacturing Corp · Jul 2007
MODIFICATION TO:SBI RINGFIX
K071394 · Small Bone Innovations, Inc. · Jun 2007
IOS EXTERNAL FIXATOR, MODEL 2-0-0
K070724 · Intelligent Orthopaedics, Ltd. · May 2007