Cleared Traditional

K945426 - ARTHREX CANCELLOUS SCREW AND WASHER

K945426 is the FDA 510(k) clearance for ARTHREX CANCELLOUS SCREW AND WASHER by Arthrex, Inc.. It is a Class 2 Orthopedic device (product code HWC) cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K945426 · Arthrex, Inc. · Orthopedic device
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Apr 1995
Decision
161d
Days
Class 2
Risk

K945426 is an FDA 510(k) clearance for the ARTHREX CANCELLOUS SCREW AND WASHER. 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 14, 1995 after a review of 161 days - an extended review cycle.

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 K945426 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received November 04, 1994
Decision Date April 14, 1995
Days to Decision 161 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d slower than avg
Panel avg: 122d · This submission: 161d
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 K945426.
IMPROVED PASSIVATION METHOD FOR METALLIC ORTHOPAEDIC IMPLANTS
K934590 · Smith & Nephew Richards, Inc. · Jun 1995
LINVATEC STASYS-PES FIXATION DEVICE
K934321 · Linvatec Corp. · May 1995
ACUTRAK PLUS FIXATION SYSTEM
K944330 · Acu Med, Inc. · May 1995
BONE MULCH SCREW
K941941 · Biomet, Inc. · Feb 1995
6.2 VITALLIUM ALLOY CANCELLOUS BONE SCREW
K944213 · Howmedica Corp. · Dec 1994
CORTICAL BONE SCREW
K942340 · Acu Med, Inc. · Dec 1994