Cleared Traditional

K040542 - SMITH & NEPHEW GTS SLEEVE AND GTS TAPERED SCREW

K040542 is an FDA 510(k) clearance for SMITH & NEPHEW GTS SLEEVE AND GTS TAPER..., 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 170-day FDA review.

K040542 · Smith & Nephew, Inc. · Orthopedic device
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Aug 2004
Decision
170d
Days
Class 2
Risk

K040542 is an FDA 510(k) clearance for the SMITH & NEPHEW GTS SLEEVE AND GTS TAPERED SCREW. 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 August 19, 2004 after a review of 170 days - an extended review 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: 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 Smith & Nephew, Inc. devices

FDA 510(k) Submission Details - K040542

510(k) Number K040542 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 2004
Decision Date August 19, 2004
Days to Decision 170 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 slower than avg
Panel avg: 122d · This submission: 170d
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 927
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K040542.
SYNTHES (USA) [SYNTHES} PERI-PROSTHETIC SCREWS
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INION TRINION BIODEGRADABLE MENISCUS SCREW
K031714 · Inion , Ltd. · Aug 2004
VILEX BONE PLATE SYSTEM
K041287 · Vilex, Inc. · Aug 2004
TALUS OF VILEX (TOV)
K041289 · Vilex, Inc. · Aug 2004