Cleared Traditional

TISSUE FIXATION SYSTEM (K050418) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K050418 · Tfs Manufacturing Pty, Ltd. · General & Plastic Surgery device
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May 2005
Decision
87d
Days
Class 2
Risk

K050418 is an FDA 510(k) clearance for the TISSUE FIXATION SYSTEM. Classified as Mesh, Surgical, Polymeric (product code FTL), Class II - Special Controls.

Submitted by Tfs Manufacturing Pty, Ltd. (North Plympton Sa, AU). The FDA issued a Cleared decision on May 16, 2005 after a review of 87 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.3300 - the FDA general and plastic surgery device 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 Tfs Manufacturing Pty, Ltd. devices

Submission Details

510(k) Number K050418 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 2005
Decision Date May 16, 2005
Days to Decision 87 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 115d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FTL Mesh, Surgical, Polymeric
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3300
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - FTL Mesh, Surgical, Polymeric

All 96
Devices cleared under the same product code (FTL) and FDA review panel - the closest regulatory comparables to K050418.
OPTILENE MESH LP
K053158 · Aesculap, Inc. · Jan 2006
BARD LARGE PORE SOFT MESH AND SOFT MESH PRESHAPED
K052155 · C.R. Bard, Inc. · Oct 2005
VICRYL * MESH BAG
K051701 · Ethicon, Inc. · Sep 2005
BARD CK PARASTOMAL HERNIA PATCH, MODELS 0118001, 0118002, 0118003, 0118004
K042026 · C.R. Bard, Inc. · Sep 2004
ULTRAPRO MESH
K033337 · Ethicon, Inc. · Apr 2004
BARD SOFT MESH, MODELS 0117001, 0117002, 0117003, 0117004, 0117005, 0117006, 0117007
K033814 · C.R. Bard, Inc. · Mar 2004