Cleared Traditional

K160854 - MaxBraid BroadBand Suture and Expressbr...

K160854 is an FDA 510(k) clearance for MaxBraid BroadBand Suture and Expressbr..., manufactured by Biomet Manafacturing Corp.. The device is a Class 2 General & Plastic Surgery device with product code GAT cleared through the Traditional 510(k) pathway after a 266-day FDA review.

K160854 · Biomet Manafacturing Corp. · General & Plastic Surgery device
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Dec 2016
Decision
266d
Days
Class 2
Risk

K160854 is an FDA 510(k) clearance for the MaxBraid BroadBand Suture and Expressbraid BroadBand Graft Manipulation Suture. Classified as Suture, Nonabsorbable, Synthetic, Polyethylene (product code GAT), Class II - Special Controls.

Submitted by Biomet Manafacturing Corp. (Warsaw, US). The FDA issued a Cleared decision on December 19, 2016 after a review of 266 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 Biomet Manafacturing Corp. devices

FDA 510(k) Submission Details - K160854

510(k) Number K160854 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 2016
Decision Date December 19, 2016
Days to Decision 266 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
151d slower than avg
Panel avg: 115d · This submission: 266d
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 114
Devices cleared under the same product code (GAT) and FDA review panel - the closest regulatory comparables to K160854.
SutureTape
K171296 · Arthrex, Inc. · May 2017
ExpressBraid Graft Manipulation
K163651 · Biomet Manufacturing Corp · Feb 2017
SpeedStitch Suture Passer
K163142 · ArthroCare Corporation · Jan 2017
PERMATAPE
K162247 · Medos International SARL · Dec 2016
XBraid TT Suture Tape
K162310 · Stryker · Nov 2016
SPEEDTRAP Graft Preparation System
K161638 · Medos International SARL · Nov 2016