Cleared Traditional

K181633 - MTF Pre-Sutured Tendon

K181633 is the FDA 510(k) clearance for MTF Pre-Sutured Tendon 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 268-day FDA review.

K181633 · Musculoskeletal Transplant Foundation · General & Plastic Surgery device
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Mar 2019
Decision
268d
Days
Class 2
Risk

K181633 is an FDA 510(k) clearance for the MTF Pre-Sutured Tendon. Classified as Suture, Nonabsorbable, Synthetic, Polyethylene (product code GAT), Class II - Special Controls.

Submitted by Musculoskeletal Transplant Foundation (Edison, US). The FDA issued a Cleared decision on March 15, 2019 after a review of 268 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 Musculoskeletal Transplant Foundation devices

Submission Details

510(k) Number K181633 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 2018
Decision Date March 15, 2019
Days to Decision 268 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
153d slower than avg
Panel avg: 115d · This submission: 268d
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 Consultant

Musculoskeletal Clinical Reulatory Advisers, LLC
Katrina Carroll

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K181633.
DemeTECH DemeFORCE Nonabsorbable Surgical Suture
K190777 · Demetech Corporation · Jul 2019
Force Fiber Suture
K191268 · Teleflex Medical Incorporated · Jun 2019
HS Fiber
K190817 · Riverpoint Medical · May 2019
Force Fiber White and White/Blue, White/Black, Blue, and White/Green sutures
K181774 · Teleflex Medical Incorporated · Oct 2018
DYNACORD Suture
K181182 · Medos International SARL · Aug 2018
NovoStitch Pro Meniscal Repair System, CTX-A004 (size 0)
K181772 · Ceterix Orthopaedics, Inc. · Aug 2018