Cleared Abbreviated

K041216 - SMITH & NEPHEW ULTRABRAID SUTURE

K041216 is the FDA 510(k) clearance for SMITH & NEPHEW ULTRABRAID SUTURE by Smith & Nephew, Inc.. It is a Class 2 General & Plastic Surgery device (product code GAT) cleared through the Abbreviated 510(k) pathway after a 28-day FDA review.

K041216 · Smith & Nephew, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2004
Decision
28d
Days
Class 2
Risk

K041216 is an FDA 510(k) clearance for the SMITH & NEPHEW ULTRABRAID SUTURE. Classified as Suture, Nonabsorbable, Synthetic, Polyethylene (product code GAT), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Mansfield, US). The FDA issued a Cleared decision on June 7, 2004 after a review of 28 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.5000 - the FDA general and plastic surgery device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Smith & Nephew, Inc. devices

Submission Details

510(k) Number K041216 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 2004
Decision Date June 07, 2004
Days to Decision 28 days
Submission Type Abbreviated
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 115d · This submission: 28d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code GAT Suture, Nonabsorbable, Synthetic, Polyethylene
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5000
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 - GAT Suture, Nonabsorbable, Synthetic, Polyethylene

All 94
Devices cleared under the same product code (GAT) and FDA review panel - the closest regulatory comparables to K041216.
SMITH & NEPHEW CONTINUOUS LOOP FIXATION DEVICE
K052652 · Smith & Nephew, Inc. · Oct 2005
ARTHREX SUTURE GRAFTING KIT
K041553 · Arthrex, Inc. · Dec 2004
ARTHREX FIBERWIRE WITH SILK
K041589 · Arthrex, Inc. · Aug 2004
DURABRAID SUTURE
K040789 · Smith & Nephew, Inc. · Jun 2004
FORCE FIBER BLUE CO-BRAIDED POLYETHYLENE NONABSORBABLE SURGICAL SUTURE
K040472 · Teleflex Medical · Mar 2004
FORCE FIBER
K033654 · Teleflex Medical · Jan 2004