Cleared Traditional

K170278 - OptiFix AT Absorbable Fixation System w...

K170278 is an FDA 510(k) clearance for OptiFix AT Absorbable Fixation System w..., manufactured by C.R. Bard, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GDW cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K170278 · C.R. Bard, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2017
Decision
121d
Days
Class 2
Risk

K170278 is an FDA 510(k) clearance for the OptiFix AT Absorbable Fixation System with Articulating Technology - 30 Faste.... Classified as Staple, Implantable (product code GDW), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Warwick, US). The FDA issued a Cleared decision on May 31, 2017 after a review of 121 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4750 - 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 C.R. Bard, Inc. devices

FDA 510(k) Submission Details - K170278

510(k) Number K170278 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 2017
Decision Date May 31, 2017
Days to Decision 121 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
6d slower than avg
Panel avg: 115d · This submission: 121d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GDW Device Classification - Class 2, Special Controls

Product Code GDW Staple, Implantable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4750
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 - GDW Staple, Implantable

All 183
Devices cleared under the same product code (GDW) and FDA review panel - the closest regulatory comparables to K170278.
Tri-Staple 2.0 Reinforced Reload
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AEON Endoscopic Stapler
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ECHELON CIRCULAR Powered Stapler
K163523 · Ethicon Endo-Surgery, LLC · Apr 2017
OptiFix Open Absorbable Fixation System - 20 absorbable fasteners
K163698 · C.R. Bard, Inc. · Apr 2017
Signia Four-Bay Smart Charger (to be used with Signia Stapler)
K170348 · Covidien · Mar 2017