Cleared Traditional

K123875 - AAP RADIUS SET 2.5

K123875 is an FDA 510(k) clearance for AAP RADIUS SET 2.5, 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 84-day FDA review.

K123875 · Aap Implantate AG · Orthopedic device
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Mar 2013
Decision
84d
Days
Class 2
Risk

K123875 is an FDA 510(k) clearance for the AAP RADIUS SET 2.5. 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 11, 2013 after a review of 84 days - a notably fast clearance 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: 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 - K123875

510(k) Number K123875 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 2012
Decision Date March 11, 2013
Days to Decision 84 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
38d faster than avg
Panel avg: 122d · This submission: 84d
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 1222
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K123875.
VARIAX 2 COMPRESSION PLATING SYSTEM
K130009 · Stryker Trauma AG · Mar 2013
AXSOS PROXIMAL LATERAL TIBIA LONG PLATES
K123403 · Stryker Trauma AG · Mar 2013
OIC DISTAL RADIUS PLATING SYSTEM, OIC PROXIMAL HUMERUS PLATING SYSTEM, OIC CLAVICLE PLATING SYSTEM, THE OIC SMALL FRAGME
K123832 · The Orthopaedic Implant Company (Oic) · Mar 2013
SUPERIOR LATERAL VARIAX CLAVICLE PLATE
K130116 · Stryker Trauma AG · Mar 2013
ANKLE TRAUMA SYSTEM
K122936 · Orthopro, LLC · Feb 2013
PICCOLO COMPOSITE PLATE SYSTEM
K130061 · CarboFix Orthopedics , Ltd. · Feb 2013