Cleared Traditional

K053543 - ARTHREX ARTHOERESIS IMPLANT

K053543 is the FDA 510(k) clearance for ARTHREX ARTHOERESIS IMPLANT by Arthrex, Inc.. It is a Class 2 Orthopedic device (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

Submission Details

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.

Device Classification

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 564
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K053543.
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SMITH & NEPHEW 6.5MM AND 8.0MM CANNULATED SCREWS
K060736 · Smith & Nephew, Inc. · Apr 2006
BIORAPTOR SUTURE ANCHOR, TWINFIX 2.8 MM SUTURE ANCHOR, TWINFIX 3.5 MM SUTURE ANCHOR
K053344 · Smith & Nephew, Inc. · Feb 2006
ARTHREX TITANIUM AND BIO-DEGRADABLE (POLYMER) IMPLANTS
K053338 · Arthrex, Inc. · Jan 2006
5TH METATARSAL FRACTURE SCREW
K053136 · Wrightmedicaltechnologyinc · Jan 2006