Cleared Traditional

K053215 - SURGICAL MESH SYSTEM

K053215 is an FDA 510(k) clearance for SURGICAL MESH SYSTEM, manufactured by Nuvasive, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FTL cleared through the Traditional 510(k) pathway after a 242-day FDA review.

K053215 · Nuvasive, Inc. · General & Plastic Surgery device
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Jul 2006
Decision
242d
Days
Class 2
Risk

K053215 is an FDA 510(k) clearance for the SURGICAL MESH SYSTEM. Classified as Mesh, Surgical, Polymeric (product code FTL), Class II - Special Controls.

Submitted by Nuvasive, Inc. (San Diego, US). The FDA issued a Cleared decision on July 17, 2006 after a review of 242 days - an extended review 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. 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 Nuvasive, Inc. devices

FDA 510(k) Submission Details - K053215

510(k) Number K053215 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 2005
Decision Date July 17, 2006
Days to Decision 242 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
127d slower than avg
Panel avg: 115d · This submission: 242d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 276
Devices cleared under the same product code (FTL) and FDA review panel - the closest regulatory comparables to K053215.
ENDOFAST RELIANT SYSTEM
K060329 · Endogun Medical Systems · Sep 2006
TRULENE MESH
K060018 · Sutures India Pvt., Ltd. · Jul 2006
OPTILENE MESH
K061704 · Aesculap, Inc. · Jul 2006
TYRX ANTIMICROBIAL MESH
K053656 · Tyrx Pharma, Inc. · Jul 2006
BARD EXTRA LARGE COMPOSIX KUGEL HERNIA PATCH
K061314 · Davol Inc., Sub. C. R. Bard, Inc. · Jun 2006
PROCEED SURGICAL MESH
K060713 · Ethicon, Inc. · May 2006