Cleared Traditional

K033749 - TITANIUM CANNULATED INTERFERENCE SCREW

K033749 is an FDA 510(k) clearance for TITANIUM CANNULATED INTERFERENCE SCREW, manufactured by Advanced Biomaterials. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K033749 · Advanced Biomaterials · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2004
Decision
84d
Days
Class 2
Risk

K033749 is an FDA 510(k) clearance for the TITANIUM CANNULATED INTERFERENCE SCREW. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Advanced Biomaterials (St. Jeannet, FR). The FDA issued a Cleared decision on February 23, 2004 after a review of 84 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 Biomaterials devices

FDA 510(k) Submission Details - K033749

510(k) Number K033749 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 2003
Decision Date February 23, 2004
Days to Decision 84 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
38d faster than avg
Panel avg: 122d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HWC Device Classification - Class 2, Special Controls

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 827
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K033749.
BILOK ST SCREW
K033792 · Biocomposites, Ltd. · Mar 2004
SYNTHES 2.4 MM TITANIUM (TI.) LOCKING SCREWS
K033975 · Synthes (Usa) · Mar 2004
KOMPRESSOR SCREW SYSTEM
K040356 · Kinetikos Medical, Inc. · Mar 2004
ACUMED LOWER EXTREMITY CONGRUENT PLATE SYSTEM
K033639 · Acumed, LLC · Jan 2004
BIOANCHOR WITH DISPOSABLE DRIVER
K033804 · Linvatec Corp. · Dec 2003
COAPT ENDOTINE CHIN 3.5 DEVICE
K033524 · Coapt Systems, Inc. · Dec 2003