Cleared Traditional

K040542 - SMITH & NEPHEW GTS SLEEVE AND GTS TAPER...

K040542 is the FDA 510(k) clearance for SMITH & NEPHEW GTS SLEEVE AND GTS TAPER... by Smith & Nephew, Inc.. It is a Class 2 Orthopedic device (product code HWC) cleared through the Traditional 510(k) pathway after a 170-day FDA review.

K040542 · Smith & Nephew, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

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 K040542.
SYNTHES 1.0/1.2 MM PLUSDRIVE SCREWS
K042356 · Synthes (Usa) · Oct 2004
BIOPRO SUBTALAR IMPLANT
K041936 · Biopro, Inc. · Sep 2004
SYNTHES (USA) [SYNTHES} PERI-PROSTHETIC SCREWS
K041533 · Synthes (Usa) · Sep 2004
LACTOSCREW SCREW ANCHOR
K033355 · Biomet Orthopedics, Inc. · Jun 2004
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