Cleared Traditional

K040331 - SMITH AND NEPHEW TITANIUM INTERFERENCE ...

K040331 is the FDA 510(k) clearance for SMITH AND NEPHEW TITANIUM INTERFERENCE ... by Smith & Nephew, Inc.. It is a Class 2 Orthopedic device (product code HWC) cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K040331 · Smith & Nephew, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2004
Decision
63d
Days
Class 2
Risk

K040331 is an FDA 510(k) clearance for the SMITH AND NEPHEW TITANIUM INTERFERENCE SCREWS. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Andover, US). The FDA issued a Cleared decision on April 14, 2004 after a review of 63 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 Smith & Nephew, Inc. devices

Submission Details

510(k) Number K040331 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 2004
Decision Date April 14, 2004
Days to Decision 63 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
59d faster than avg
Panel avg: 122d · This submission: 63d
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 K040331.
SYNTHES (USA) HYDROXYAPATITE (HA) COATED SCHANZ SCREWS
K040701 · Synthes (Usa) · Jun 2004
MODIFICATION TO SMITH & NEPHEW INTRAMEDULLARY HIP SCREW
K040656 · Smith & Nephew, Inc. · May 2004
MICROMAX SUTURE ANCHOR
K040475 · Biomet, Inc. · May 2004
HERCULON SOFT TISSUE REATTACHMENT SYSTEM
K040594 · United States Surgical, A Division of Tyco Healthc · Mar 2004
SYNTHES 2.4 MM TITANIUM (TI.) LOCKING SCREWS
K033975 · Synthes (Usa) · Mar 2004
ACUMED LOWER EXTREMITY CONGRUENT PLATE SYSTEM
K033639 · Acumed, LLC · Jan 2004