Cleared Traditional

Force Fiber White and White/Blue, White/Black, Blue, and White/Green sutures (K181774) - FDA 510(k) Clearance

Also marketed or referenced as:
Force Fiber OrthoTape suture Bondek suture and Bondek Plus suture Monodek suture Polyglytone*6211 suture

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

K181774 · Teleflex Medical Incorporated · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2018
Decision
99d
Days
Class 2
Risk

K181774 is an FDA 510(k) clearance for the Force Fiber White and White/Blue, White/Black, Blue, and White/Green sutures. Classified as Suture, Nonabsorbable, Synthetic, Polyethylene (product code GAT), Class II - Special Controls.

Submitted by Teleflex Medical Incorporated (Mansfield, US). The FDA issued a Cleared decision on October 10, 2018 after a review of 99 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 Teleflex Medical Incorporated devices

Submission Details

510(k) Number K181774 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 2018
Decision Date October 10, 2018
Days to Decision 99 days
Submission Type Traditional
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
16d faster than avg
Panel avg: 115d · This submission: 99d
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 80
Devices cleared under the same product code (GAT) and FDA review panel - the closest regulatory comparables to K181774.
Force Fiber Suture
K191268 · Teleflex Medical Incorporated · Jun 2019
HS Fiber
K190817 · Riverpoint Medical · May 2019
MTF Pre-Sutured Tendon
K181633 · Musculoskeletal Transplant Foundation · Mar 2019
DYNACORD Suture
K181182 · Medos International SARL · Aug 2018
NovoStitch Pro Meniscal Repair System, CTX-A004 (size 0)
K181772 · Ceterix Orthopaedics, Inc. · Aug 2018
SuperBall Meniscal Repair System
K180191 · Arcuro Medical , Ltd. · Jun 2018