Cleared Traditional

4.0 MM ARTHREX BIO-TENDOESIS SCREW, MODEL AR-1540B (K020043) - FDA 510(k) Clearance

Also marketed or referenced as:
5.5 MM ARTHREX BIO-TENODESIS SCREW, MODELS AR-1555B

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K020043 · Arthrex, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2002
Decision
85d
Days
Class 2
Risk

K020043 is an FDA 510(k) clearance for the 4.0 MM ARTHREX BIO-TENDOESIS SCREW, MODEL AR-1540B. 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 2, 2002 after a review of 85 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Arthrex, Inc. devices

Submission Details

510(k) Number K020043 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 07, 2002
Decision Date April 02, 2002
Days to Decision 85 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
37d faster than avg
Panel avg: 122d · This submission: 85d
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 400
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K020043.
SYNTHES 2.4 MM CANNULATED COMPRESSION SCREW
K021556 · Synthes (Usa) · Aug 2002
SMALL HAMMER TOE PIN
K021828 · Biomet, Inc. · Jul 2002
ARTHROTEK RESORBABLE NO-PROFILE LACTOSORB L-15 SCREW & WASHER
K021832 · Biomet, Inc. · Jun 2002
SMITH & NEPHEW TWINFIX TI QUICK T
K020159 · Smith & Nephew, Inc. · Mar 2002
SURGICAL DYNAMICS MENISCAL STAPLE
K013890 · United States Surgical, A Division of Tyco Healthc · Dec 2001
REUNITE FUSION SCREW
K011451 · Biomet, Inc. · Dec 2001