Cleared Traditional

K032072 - LACTOSORB L15 SCREW ANCHOR WITH LACTOCA...

K032072 is the FDA 510(k) clearance for LACTOSORB L15 SCREW ANCHOR WITH LACTOCA... by Arthrotek, Inc.. It is a Class 2 Orthopedic device (product code HWC) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K032072 · Arthrotek, Inc. · Orthopedic device
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Oct 2003
Decision
90d
Days
Class 2
Risk

K032072 is an FDA 510(k) clearance for the LACTOSORB L15 SCREW ANCHOR WITH LACTOCARBONATE SUTURE. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Arthrotek, Inc. (Warsaw, US). The FDA issued a Cleared decision on October 1, 2003 after a review of 90 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 Arthrotek, Inc. devices

Submission Details

510(k) Number K032072 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 2003
Decision Date October 01, 2003
Days to Decision 90 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 122d · This submission: 90d
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 569
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K032072.
MODIFICATION TO STRYKER BIOABSORBABLE INTERFERENCE SCREW SYSTEM
K033252 · Stryker Endoscopy · Nov 2003
LACTOSORB TIBIAL L-15 SCREW AND WASHER
K033233 · Biomet, Inc. · Nov 2003
ARTHREX BIO-COMPRESSION SCREW, SMALL, ARTHREX BIO-COMPRESSION SCREW, LARGE, MODELS AR-5024B, AR-5025B
K032098 · Arthrex, Inc. · Oct 2003
ARTHREX TRIMIT SCREW, MODEL AR-4161B
K031945 · Arthrex, Inc. · Sep 2003
ALANTECH GRAFT FIXATION SCREW
K031937 · Arthrocare Corp. · Sep 2003
LORENZ 2.4 SELF DRILLING SCREWS
K032228 · Walter Lorenz Surgical, Inc. · Aug 2003