Cleared Traditional

K132554 - AAP LOQTEQ PROXIMAL MEDIAL TIBIA PLATE 3.5

K132554 is an FDA 510(k) clearance for AAP LOQTEQ PROXIMAL MEDIAL TIBIA PLATE 3.5, 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 50-day FDA review.

K132554 · Aap Implantate AG · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2013
Decision
50d
Days
Class 2
Risk

K132554 is an FDA 510(k) clearance for the AAP LOQTEQ PROXIMAL MEDIAL TIBIA PLATE 3.5. 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 October 3, 2013 after a review of 50 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 - K132554

510(k) Number K132554 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 2013
Decision Date October 03, 2013
Days to Decision 50 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
72d faster than avg
Panel avg: 122d · This submission: 50d
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 K132554.
2.5MM INLINE FUSION PLATE
K131867 · Biomet, Inc. · Oct 2013
VARIAX 2 SYSTEM
K132502 · Stryker Trauma AG · Oct 2013
SYNTHES 2.7MM AND 3.5MM VARIABLE ANGLE LCP MIDFOOT/HINDFOOT SYSTEM
K131186 · Synthes USA Products, LLC · Oct 2013
LOCKING PLATE SYSTEM
K132642 · Beijing Libeier Bio-Engineering Institute Co., Ltd. · Oct 2013
ARTHREX COMPRESSION PLATES
K130510 · Arthrex, Inc. · Sep 2013
MAXLOCK EXTREME SYSTEM
K132591 · Orthohelix Surgical Designs, Inc. · Sep 2013