Cleared Traditional

K123241 - ARTHREX FRACTURE PLATES

K123241 is an FDA 510(k) clearance for ARTHREX FRACTURE PLATES, manufactured by Arthrex, Inc.. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 170-day FDA review.

K123241 · Arthrex, Inc. · Orthopedic device
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Apr 2013
Decision
170d
Days
Class 2
Risk

K123241 is an FDA 510(k) clearance for the ARTHREX FRACTURE 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 April 5, 2013 after a review of 170 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

FDA 510(k) Submission Details - K123241

510(k) Number K123241 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 2012
Decision Date April 05, 2013
Days to Decision 170 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
48d slower than avg
Panel avg: 122d · This submission: 170d
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 1225
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K123241.
ORTHOLOC(R) 3DI ANKLE PLATING SYSTEM
K131093 · Wrightmedicaltechnologyinc · May 2013
GRIDLOCK PLATING SYSTEM
K130964 · Trilliant Surgical, Ltd. · May 2013
DOUBLE ENGINE BONE PLATE AND SCREW SYSTEMS
K130108 · Xiamen Double Engine Medical Material Co., Ltd. · Apr 2013
LOCKING BONE PLATES AND SCREWS
K130340 · Weigao Orthopaedic Device Co., Ltd. · Apr 2013
FLOWER SMALL AND MEDIUM BONE IMPLANTS
K123562 · Flower Orthopedics Corporation · Mar 2013
BIOMET RECONSTRUCTIVE WEDGES MODEL 110003660-99, 110003797-831
K122770 · Biomet Manufacturing Corp · Mar 2013