Cleared Traditional

K053543 - ARTHREX ARTHOERESIS IMPLANT

K053543 is an FDA 510(k) clearance for ARTHREX ARTHOERESIS IMPLANT, manufactured by Arthrex, Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K053543 · Arthrex, Inc. · Orthopedic device
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Apr 2006
Decision
104d
Days
Class 2
Risk

K053543 is an FDA 510(k) clearance for the ARTHREX ARTHOERESIS IMPLANT. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Arthrex, Inc. (Naples, US). The FDA issued a Cleared decision on April 3, 2006 after a review of 104 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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 - K053543

510(k) Number K053543 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 2005
Decision Date April 03, 2006
Days to Decision 104 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
18d faster than avg
Panel avg: 122d · This submission: 104d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HWC Device Classification - Class 2, Special Controls

Product Code HWC Screw, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 - HWC Screw, Fixation, Bone

All 931
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K053543.
UNIVERSAL LOCKING SYSTEM, 3.5MM PLATES AND SCREWS-4936 PLATES,4835 SCREWS
K060710 · Zimmer, Inc. · Apr 2006
SMITH & NEPHEW 6.5MM AND 8.0MM CANNULATED SCREWS
K060736 · Smith & Nephew, Inc. · Apr 2006
HI-FI ULTRAFIX KNOTLESS MINIMITE SUTURE ANCHOR
K060714 · Conmed Linvatec · Apr 2006
INION HEXALON BIODEGRADABLE ACL/PCL SCREW
K060393 · Inion , Ltd. · Mar 2006
CSS CANNULATED SCREW SYSTEM
K060428 · Orthohelix Surgical Designs, Inc. · Mar 2006
BIORAPTOR SUTURE ANCHOR, TWINFIX 2.8 MM SUTURE ANCHOR, TWINFIX 3.5 MM SUTURE ANCHOR
K053344 · Smith & Nephew, Inc. · Feb 2006