Cleared Special

K141394 - X-REPAIR

K141394 is an FDA 510(k) clearance for X-REPAIR, manufactured by Synthasome. The device is a Class 2 General & Plastic Surgery device with product code FTL cleared through the Special 510(k) pathway after a 70-day FDA review.

K141394 · Synthasome · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2014
Decision
70d
Days
Class 2
Risk

K141394 is an FDA 510(k) clearance for the X-REPAIR. Classified as Mesh, Surgical, Polymeric (product code FTL), Class II - Special Controls.

Submitted by Synthasome (San Diego, US). The FDA issued a Cleared decision on August 6, 2014 after a review of 70 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.3300 - 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.

FDA 510(k) Submission Details - K141394

510(k) Number K141394 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 2014
Decision Date August 06, 2014
Days to Decision 70 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
45d faster than avg
Panel avg: 115d · This submission: 70d
Pathway characteristics
Modification to existing cleared device.

FTL Device Classification - Class 2, Special Controls

Product Code FTL Mesh, Surgical, Polymeric
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3300
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 - FTL Mesh, Surgical, Polymeric

All 335
Devices cleared under the same product code (FTL) and FDA review panel - the closest regulatory comparables to K141394.
ETHICON PHYSIOMESH OPEN FLEXIBLE COMPOSITE MESH DEVICE
K141560 · Ethicon, Inc. · Oct 2014
PARIETENE MACROPOROUS MESH
K142091 · Sofradim Production · Oct 2014
PREMIUM
K133889 · Cousin Biotech Sas · Sep 2014
X-REPAIRSL
K141499 · Synthasome, Inc. · Jul 2014
FREEDOM INGUINAL HERNIA REPAIR IMPLANT-25MM/40MM/40MM WITH EXTENDED DISK
K140967 · Insightra Medical · Jun 2014
ULTRAPRO COMFORT PLUG
K133198 · Ethicon, Inc. · May 2014
K141394 · X-REPAIR
Download PDF FDA Summary Synthasome