Cleared Special

K111153 - SORBAFIX (TM) ABSORBABLE FIXATION SYSTEM

K111153 is the FDA 510(k) clearance for SORBAFIX (TM) ABSORBABLE FIXATION SYSTEM by C.R. Bard, Inc.. It is a Class 2 General & Plastic Surgery device (product code GDW) cleared through the Special 510(k) pathway after a 29-day FDA review.

K111153 · C.R. Bard, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2011
Decision
29d
Days
Class 2
Risk

K111153 is an FDA 510(k) clearance for the SORBAFIX (TM) ABSORBABLE FIXATION SYSTEM, PERMAFIX (TM) FIXATION SYSTEM. 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 24, 2011 after a review of 29 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 C.R. Bard, Inc. devices

Submission Details

510(k) Number K111153 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 2011
Decision Date May 24, 2011
Days to Decision 29 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
86d faster than avg
Panel avg: 115d · This submission: 29d
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 156
Devices cleared under the same product code (GDW) and FDA review panel - the closest regulatory comparables to K111153.
ECHELON 60 ENDOSCOPIC LINEAR CUTTER RELOAD, BLACK MODEL ECR60T, ECHELON 45 ENDOSCOPIC LINEAR CUTTER RELOAD, BLACK MODEL
K112056 · Ethicon Endo-Surgery, LLC · Dec 2011
VALUTRUS REUSABLE CIRCULAR STAPLER AND DISPOSABLE RELOADS
K111195 · Ethicon Endo-Surgery, Inc. · Aug 2011
ENDOPATH ETS 35MM ENDOSCOPIC LINEAR CUTTER AND RELOADS, AND ETS-FLEX 35MM ENDOSCOPIC ARTICULATING LINEAR CUTTER AND RELO
K111111 · Ethicon Endo-Surgery, LLC · Jun 2011
REUSABLE PPH CIRCULAR STAPLER HANDLE, PPH CIRCULAR STAPLER RELOAD & ACCESSORY SET
K103672 · Ethicon Endo-Surgery, LLC · Apr 2011
ECHELON FLEX 45 / 60 POWERED ARTICULATING ENDOSCOPIC LINEAR CUTTER
K110385 · Ethicon Endo-Surgery, Inc. · Mar 2011
REUSABLE LINEAR STAPLER HANDLE
K110049 · Ethicon Endo-Surgery, LLC · Feb 2011