Cleared Traditional

K111253 - ARTHREX DISTAL EXTREMITY PLATE SYSTEM

K111253 is the FDA 510(k) clearance for ARTHREX DISTAL EXTREMITY PLATE SYSTEM by Arthrex, Inc.. It is a Class 2 Orthopedic device (product code HRS) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K111253 · Arthrex, Inc. · Orthopedic device
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Aug 2011
Decision
90d
Days
Class 2
Risk

K111253 is an FDA 510(k) clearance for the ARTHREX DISTAL EXTREMITY PLATE SYSTEM. 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 August 2, 2011 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.

View all Arthrex, Inc. devices

Submission Details

510(k) Number K111253 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 2011
Decision Date August 02, 2011
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
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 K111253.
EVOLVE (R) TRIAD (TM) PLATING SYSTEM AND EVOLVE (R) TRIAD (TM) BONE SCREWS
K111432 · Wrightmedicaltechnologyinc · Aug 2011
SYNTHES 3.5MM LCP CLAVICLE PLATE SYSTEM
K111540 · Synthes (Usa) · Aug 2011
ORTHOPEDIATRICS BLADE PLATE SYSTEM
K110959 · OrthoPediatrics Corp. · Aug 2011
MAESTRO WRIST PLATING SYSTEM
K110271 · Biomet Manufacturing Corp · Jul 2011
EXPLOR RADIAL HEAD PLATING SYSTEM
K110201 · Biomet, Inc. · Jul 2011
COMPREHENSIVEPROXIMAL HUMERAL PLATING SYSTEM
K110320 · Biomet Manufacturing Corp · Jul 2011