Cleared Traditional

K150584 - Stryker Suture Tape

K150584 is the FDA 510(k) clearance for Stryker Suture Tape by Stryker. It is a Class 2 General & Plastic Surgery device (product code GAT) cleared through the Traditional 510(k) pathway after a 157-day FDA review.

K150584 · Stryker · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2015
Decision
157d
Days
Class 2
Risk

K150584 is an FDA 510(k) clearance for the Stryker 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 August 13, 2015 after a review of 157 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 Stryker devices

Submission Details

510(k) Number K150584 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 2015
Decision Date August 13, 2015
Days to Decision 157 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
42d slower than avg
Panel avg: 115d · This submission: 157d
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 81
Devices cleared under the same product code (GAT) and FDA review panel - the closest regulatory comparables to K150584.
XBraid TT Suture Tape
K162310 · Stryker · Nov 2016
SPEEDTRAP Graft Preparation System
K161638 · Medos International SARL · Nov 2016
ExpressBraid Graft Manipulation
K152868 · Biomet Manufacturing Corp · Feb 2016
ARTHREX BIOSUTURE
K140019 · Arthrex, Inc. · Jan 2014
TFCC FAST-FIX KIT
K132079 · Smith & Nephew, Inc. · Dec 2013
SMITH & NEPHEW ULTRATAPE
K132357 · Smith & Nephew, Inc. · Oct 2013