Cleared Traditional

K014185 - AOS CANNULATED BONE SCREW SYSTEM

K014185 is the FDA 510(k) clearance for AOS CANNULATED BONE SCREW SYSTEM by Advanced Orthopaedic Solutions, Inc.. It is a Class 2 Orthopedic device (product code HWC) cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K014185 · Advanced Orthopaedic Solutions, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2002
Decision
55d
Days
Class 2
Risk

K014185 is an FDA 510(k) clearance for the AOS CANNULATED BONE SCREW SYSTEM. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Advanced Orthopaedic Solutions, Inc. (San Pedro, US). The FDA issued a Cleared decision on February 13, 2002 after a review of 55 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 Advanced Orthopaedic Solutions, Inc. devices

Submission Details

510(k) Number K014185 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 2001
Decision Date February 13, 2002
Days to Decision 55 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
67d faster than avg
Panel avg: 122d · This submission: 55d
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 553
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K014185.
MODIFICATION TO STRAIGHT-IN BONE SCREW FIXATION SYSTEM
K020446 · American Medical Systems, Inc. · Mar 2002
LORENZ SELF DRILLING SCREWS
K013954 · Walter Lorenz Surgical, Inc. · Feb 2002
BIOABSORBABLE INTERFERENCE SCREW MEGAFIX
K013107 · Karl Storz Endoscopy · Feb 2002
SURGICAL DYNAMICS MENISCAL STAPLE
K013890 · United States Surgical, A Division of Tyco Healthc · Dec 2001
REUNITE FUSION SCREW
K011451 · Biomet, Inc. · Dec 2001
SOFT TISSUE SCREW AND WASHER
K012572 · Biomet, Inc. · Dec 2001