Cleared Traditional

K131459 - AAP K-WIRE, STEINMANN PIN, CERCLAGE WIRE

K131459 is an FDA 510(k) clearance for AAP K-WIRE, manufactured by Aap Implantate AG. The device is a Class 2 Orthopedic device with product code JDW cleared through the Traditional 510(k) pathway after a 150-day FDA review.

K131459 · Aap Implantate AG · Orthopedic device
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Optimized for regulatory review, auditing and printing
Oct 2013
Decision
150d
Days
Class 2
Risk

K131459 is an FDA 510(k) clearance for the AAP K-WIRE, STEINMANN PIN, CERCLAGE WIRE. Classified as Pin, Fixation, Threaded (product code JDW), Class II - Special Controls.

Submitted by Aap Implantate AG (Berlin, DE). The FDA issued a Cleared decision on October 17, 2013 after a review of 150 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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 - K131459

510(k) Number K131459 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 2013
Decision Date October 17, 2013
Days to Decision 150 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 slower than avg
Panel avg: 122d · This submission: 150d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDW Device Classification - Class 2, Special Controls

Product Code JDW Pin, Fixation, Threaded
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 - JDW Pin, Fixation, Threaded

All 82
Devices cleared under the same product code (JDW) and FDA review panel - the closest regulatory comparables to K131459.
ST.A.R. 90 F4 External Fixation Screws With Hydroxyapatite
K150661 · Citieffe S.R.L. · Jul 2015
VILEX ULTIMA EXTERNAL FIXATION SYSTEM WITH HA COATED PINS AND WIRES
K132820 · Vilex, Inc. · Jul 2014
OPTOSSOL COMPRESSION DEVICE SYSTEM
K140875 · Genossis, LLC · May 2014
BIOPRO KWICK-WIRE UNIVERSAL SCREW SYSTEM
K130298 · Biopro, Inc. · Jun 2013
SMITH & NEPHEW, INC. EXTERNAL FIXATION SYSTEM INSTRUMENTATION
K120871 · Smith & Nephew, Inc. · Jun 2012
ROCKWOOD CLAVICLE PINS
K103001 · DePuy Orthopaedics, Inc. · Feb 2011