Cleared Traditional

K915315 - AAP BONE PLATE

K915315 is an FDA 510(k) clearance for AAP BONE PLATE, manufactured by Aap International, Ltd.. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K915315 · Aap International, Ltd. · Orthopedic device
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Feb 1992
Decision
90d
Days
Class 2
Risk

K915315 is an FDA 510(k) clearance for the AAP BONE PLATE. 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 International, Ltd. (Bedminster, US). The FDA issued a Cleared decision on February 20, 1992 after a review of 90 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K915315

510(k) Number K915315 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 1991
Decision Date February 20, 1992
Days to Decision 90 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 122d · This submission: 90d
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 1313
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K915315.
ALPHATEC COMPRESSION HIP SCREW SYSTEM
K921622 · Alphatec Mfg., Inc. · Jul 1992
RADIUS OSTEOTOMY PLATES
K914804 · Link America, Inc. · Apr 1992
SCHWABE RADIUS PLATES
K914803 · Link America, Inc. · Apr 1992
SYNTHES(R) TITANIUM SMALL RECONSTRUCTION PLATE
K915818 · Synthes (Usa) · Jan 1992
LUHR PAN FIXATION SYSTEM
K913355 · Howmedica Corp. · Dec 1991
SYNTHES MAXILLOFACIAL TITANIUM MICRO SET
K912932 · Synthes (Usa) · Sep 1991