Cleared Traditional

K040656 - MODIFICATION TO SMITH & NEPHEW INTRAMEDULLARY HIP SCREW

K040656 is an FDA 510(k) clearance for MODIFICATION TO SMITH & NEPHEW INTRAMED..., manufactured by Smith & Nephew, Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K040656 · Smith & Nephew, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2004
Decision
74d
Days
Class 2
Risk

K040656 is an FDA 510(k) clearance for the MODIFICATION TO SMITH & NEPHEW INTRAMEDULLARY HIP SCREW. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Memphis, US). The FDA issued a Cleared decision on May 25, 2004 after a review of 74 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

FDA 510(k) Submission Details - K040656

510(k) Number K040656 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 2004
Decision Date May 25, 2004
Days to Decision 74 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
48d faster than avg
Panel avg: 122d · This submission: 74d
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 929
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K040656.
BIO-EUROLIG INTERFERENCE SCREW
K031939 · Fournitures Hospitalieres Industrie · Jun 2004
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LITTLE GRAFTER SCREW
K040265 · Biocomposites, Ltd. · May 2004
MICROMAX SUTURE ANCHOR
K040475 · Biomet, Inc. · May 2004
ENDOTINE TRANSBLEPH DEVICE
K040740 · Coapt Systems, Inc. · May 2004
SMITH AND NEPHEW TITANIUM INTERFERENCE SCREWS
K040331 · Smith & Nephew, Inc. · Apr 2004