Cleared Special

K191287 - OptiFix AT Absorbable Fixation System w...

K191287 is the FDA 510(k) clearance for OptiFix AT Absorbable Fixation System w... by Davol Inc., Subsidiary of C.R. Bard. It is a Class 2 General & Plastic Surgery device (product code GDW) cleared through the Special 510(k) pathway after a 64-day FDA review.

K191287 · Davol Inc., Subsidiary of C.R. Bard · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2019
Decision
64d
Days
Class 2
Risk

K191287 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 Davol Inc., Subsidiary of C.R. Bard (Warwick, US). The FDA issued a Cleared decision on July 16, 2019 after a review of 64 days - a notably fast clearance cycle.

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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Davol Inc., Subsidiary of C.R. Bard devices

Submission Details

510(k) Number K191287 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 2019
Decision Date July 16, 2019
Days to Decision 64 days
Submission Type Special
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
51d faster than avg
Panel avg: 115d · This submission: 64d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 157
Devices cleared under the same product code (GDW) and FDA review panel - the closest regulatory comparables to K191287.
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Signia Circular Adapters (for use with Signia Staplers), Tri-Staple 2.0 Circular Reloads (for use with Signia Circular Adapters)
K182475 · Covidien · Mar 2019
FasTouch Absorbable Fixation System
K181668 · Via Surgical , Ltd. · Mar 2019