Cleared Traditional

K072411 - AAP BONE PLATES AND SCREW IMPLANTS

K072411 is an FDA 510(k) clearance for AAP BONE PLATES AND SCREW IMPLANTS, 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 206-day FDA review.

K072411 · Aap Implantate AG · Orthopedic device
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Mar 2008
Decision
206d
Days
Class 2
Risk

K072411 is an FDA 510(k) clearance for the AAP BONE PLATES AND SCREW IMPLANTS. 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 March 20, 2008 after a review of 206 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 - K072411

510(k) Number K072411 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 2007
Decision Date March 20, 2008
Days to Decision 206 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
84d slower than avg
Panel avg: 122d · This submission: 206d
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 1279
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K072411.
PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM VOLAR DISTAL RADIUS LOCKING PLATE FOR THE UPPER EXTREMITY-ASTM F139
K081106 · Smith & Nephew, Inc. · Jun 2008
SYNTHES 3.5 MM LCP DISTAL TIBIA T PLATES
K080522 · Synthes (Usa) · May 2008
DISTAL HUMERAL PLATES WITH ANGULAR STABILITY
K080184 · I.T.S. Implantat-Technologie-Systeme GmbH · Mar 2008
MODULAR FOOT SYSTEM
K073624 · Orthohelix Surgical Designs, Inc. · Mar 2008
VARIAX DISTAL RADIUS TORX SCREWS
K080667 · Howmedica Osteonics Corp. · Mar 2008
DC ULNAR SHORTENING SYSTEM
K073228 · Orthopro, LLC · Feb 2008