Cleared Traditional

K130590 - AAP CANNULATED SCREW 2.0

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

K130590 · Aap Implantate AG · Orthopedic device
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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

Submission Details

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.

Device Classification

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 563
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K130590.
ARTHREX COMPRESSION FT SCREWS
K132217 · Arthrex, Inc. · Nov 2013
ZIMMER MOTIONLOC SCREW FOR PERIARTICULAR LOCKING PLATE SYSTEM
K130810 · Zimmer, Inc. · Sep 2013
MEDLINE CANNULATED SCREW
K130319 · Medline Industries, Inc. · May 2013
ACUMED CANNULATED SCREW SYSTEM
K123890 · Acumed, LLC · Mar 2013
MILAGRO ADVANCE INTERFERENCE SCREW
K123362 · Depuy Mitek, A Johnson & Johnson Company · Feb 2013
ARTHROSCOPIC SURGICAL INSTRUMENTS - INTERFERENCE SCREW SYSTEMS
K122596 · Smith & Nephew, Inc. · Nov 2012