Cleared Traditional

K162310 - XBraid TT Suture Tape

K162310 is an FDA 510(k) clearance for XBraid TT Suture Tape, manufactured by Stryker. The device is a Class 2 General & Plastic Surgery device with product code GAT cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K162310 · Stryker · General & Plastic Surgery device
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Nov 2016
Decision
85d
Days
Class 2
Risk

K162310 is an FDA 510(k) clearance for the XBraid TT Suture Tape. Classified as Suture, Nonabsorbable, Synthetic, Polyethylene (product code GAT), Class II - Special Controls.

Submitted by Stryker (Greenwood Village, US). The FDA issued a Cleared decision on November 10, 2016 after a review of 85 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Stryker devices

FDA 510(k) Submission Details - K162310

510(k) Number K162310 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 2016
Decision Date November 10, 2016
Days to Decision 85 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
30d faster than avg
Panel avg: 115d · This submission: 85d
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 113
Devices cleared under the same product code (GAT) and FDA review panel - the closest regulatory comparables to K162310.
ExpressBraid Graft Manipulation
K163651 · Biomet Manufacturing Corp · Feb 2017
SpeedStitch Suture Passer
K163142 · ArthroCare Corporation · Jan 2017
PERMATAPE
K162247 · Medos International SARL · Dec 2016
SPEEDTRAP Graft Preparation System
K161638 · Medos International SARL · Nov 2016
'cottony' II TAPE, PLEDGETS
K153089 · Teleflexmedical, Inc. · Aug 2016
silky II POLYDEK, cottony II, TEVDEK II, NextStitch, DEKLENE II, DEKLENE MAXX Gabbay-Frater, NYLON, SILK, STAINLESS STEEL
K153076 · Teleflexmedical, Inc. · Jun 2016