Cleared Traditional

K130510 - ARTHREX COMPRESSION PLATES

K130510 is the FDA 510(k) clearance for ARTHREX COMPRESSION PLATES by Arthrex, Inc.. It is a Class 2 Orthopedic device (product code HRS) cleared through the Traditional 510(k) pathway after a 210-day FDA review.

K130510 · Arthrex, Inc. · Orthopedic device
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Sep 2013
Decision
210d
Days
Class 2
Risk

K130510 is an FDA 510(k) clearance for the ARTHREX COMPRESSION PLATES. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Arthrex, Inc. (Naples, US). The FDA issued a Cleared decision on September 25, 2013 after a review of 210 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 Arthrex, Inc. devices

Submission Details

510(k) Number K130510 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 2013
Decision Date September 25, 2013
Days to Decision 210 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
88d slower than avg
Panel avg: 122d · This submission: 210d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 905
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K130510.
2.5MM INLINE FUSION PLATE
K131867 · Biomet, Inc. · Oct 2013
SYNTHES 2.7MM AND 3.5MM VARIABLE ANGLE LCP MIDFOOT/HINDFOOT SYSTEM
K131186 · Synthes USA Products, LLC · Oct 2013
AAP LOQTEQ PROXIMAL MEDIAL TIBIA PLATE 3.5
K132554 · Aap Implantate AG · Oct 2013
ARIX FOOT SYSTEM
K131311 · Jeil Medical Corporation · Sep 2013
ACUMED WRIST SPANNING PLATE
K131764 · Acumed, LLC · Sep 2013
ARTHREX DISTAL RADIUS PLATE SYSTEM
K131474 · Arthrex, Inc. · Jul 2013