Cleared Traditional

K130590 - AAP CANNULATED SCREW 2.0

K130590 is an FDA 510(k) clearance for AAP CANNULATED SCREW 2.0, manufactured by Aap Implantate AG. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K130590 · Aap Implantate AG · Orthopedic device
Download Printable Device Report (PDF)
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Apr 2013
Decision
46d
Days
Class 2
Risk

K130590 is an FDA 510(k) clearance for the AAP CANNULATED SCREW 2.0. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Aap Implantate AG (Berlin, DE). The FDA issued a Cleared decision on April 22, 2013 after a review of 46 days - a notably fast clearance 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: 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 - K130590

510(k) Number K130590 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 2013
Decision Date April 22, 2013
Days to Decision 46 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
76d faster than avg
Panel avg: 122d · This submission: 46d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HWC Device Classification - Class 2, Special Controls

Product Code HWC Screw, Fixation, Bone
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 - HWC Screw, Fixation, Bone

All 923
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K130590.
OSTEOMED EXTREMIFUSE SYSTEM
K130412 · Osteomed · May 2013
ARS SCREW
K130954 · Advanced Interventional Technology, LLC · May 2013
MAXTORQUE SCREW SYSTEM
K131324 · Orthohelix Surgical Designs, Inc. · May 2013
EXTREMITY MEDICAL IP FUSION SYSTEM
K130120 · Extremity Medical, LLC · Apr 2013
MONSTER SCREW SYSTEM
K124027 · Apogee Orthosolutions · Apr 2013
MERETEC CS, CORTICAL SCREWS
K130400 · Merete Medical GmbH · Apr 2013