Cleared Traditional

K042038 - MTF ALLOGRAFT ANCHOR

K042038 is the FDA 510(k) clearance for MTF ALLOGRAFT ANCHOR by Musculoskeletal Transplant Foundation. It is a Class 2 General & Plastic Surgery device (product code GAT) cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K042038 · Musculoskeletal Transplant Foundation · General & Plastic Surgery device
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Dec 2004
Decision
147d
Days
Class 2
Risk

K042038 is an FDA 510(k) clearance for the MTF ALLOGRAFT ANCHOR. Classified as Suture, Nonabsorbable, Synthetic, Polyethylene (product code GAT), Class II - Special Controls.

Submitted by Musculoskeletal Transplant Foundation (Potomac, US). The FDA issued a Cleared decision on December 23, 2004 after a review of 147 days - within the typical 510(k) review window.

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 Musculoskeletal Transplant Foundation devices

Submission Details

510(k) Number K042038 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 2004
Decision Date December 23, 2004
Days to Decision 147 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d slower than avg
Panel avg: 115d · This submission: 147d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 95
Devices cleared under the same product code (GAT) and FDA review panel - the closest regulatory comparables to K042038.
FORCE FIBER BLACK CO-BRAID POLYETHYLENE NON-ABSORBABLE SURGICAL SUTURE
K070673 · Teleflexmedical, Inc. · Apr 2007
FORCE FIBER POLYETHYLENE NONABSORBABLE SUTURE
K063778 · Teleflex Medical · Feb 2007
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
SMITH & NEPHEW ULTRABRAID SUTURE
K041216 · Smith & Nephew, Inc. · Jun 2004