Cleared Traditional

K041553 - ARTHREX SUTURE GRAFTING KIT

K041553 is an FDA 510(k) clearance for ARTHREX SUTURE GRAFTING KIT, manufactured by Arthrex, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GAT cleared through the Traditional 510(k) pathway after a 184-day FDA review.

K041553 · Arthrex, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2004
Decision
184d
Days
Class 2
Risk

K041553 is an FDA 510(k) clearance for the ARTHREX SUTURE GRAFTING KIT. Classified as Suture, Nonabsorbable, Synthetic, Polyethylene (product code GAT), Class II - Special Controls.

Submitted by Arthrex, Inc. (Naples, US). The FDA issued a Cleared decision on December 10, 2004 after a review of 184 days - an extended review 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 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 General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Arthrex, Inc. devices

FDA 510(k) Submission Details - K041553

510(k) Number K041553 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 2004
Decision Date December 10, 2004
Days to Decision 184 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
69d slower than avg
Panel avg: 115d · This submission: 184d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GAT Device Classification - Class 2, Special Controls

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 147
Devices cleared under the same product code (GAT) and FDA review panel - the closest regulatory comparables to K041553.
SMITH & NEPHEW CONTINUOUS LOOP FIXATION DEVICE
K052652 · Smith & Nephew, Inc. · Oct 2005
NONABSORBABLE (POLYETHYLENE TEREPHTHALATE) SURGICAL SUTURE
K041512 · Sutures India Private Limited · Jun 2005
MTF ALLOGRAFT ANCHOR
K042038 · Musculoskeletal Transplant Foundation · Dec 2004
UNIESTER C
K042286 · United Medical Industries Co. , Ltd. · Dec 2004
OPUS SPEEDSTITCH SUTURE DEVICE
K042031 · Opus Medical, Inc. · Oct 2004
ORTHOFIBER
K041894 · Cp Medical · Sep 2004