Cleared Traditional

Polydioxanone Surgical Scaffold (K181094) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K181094 · Lntegra Lifesciences · General & Plastic Surgery device
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Aug 2018
Decision
99d
Days
Class 2
Risk

K181094 is an FDA 510(k) clearance for the Polydioxanone Surgical Scaffold. Classified as Mesh, Surgical, Polymeric (product code FTL), Class II - Special Controls.

Submitted by Lntegra Lifesciences (Princeton, US). The FDA issued a Cleared decision on August 2, 2018 after a review of 99 days - within the typical 510(k) review window.

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 Lntegra Lifesciences devices

Submission Details

510(k) Number K181094 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 2018
Decision Date August 02, 2018
Days to Decision 99 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
16d faster than avg
Panel avg: 115d · This submission: 99d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Consultant

Hogan Lovells US LLP
Janice Hogan

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FTL Mesh, Surgical, Polymeric

All 132
Devices cleared under the same product code (FTL) and FDA review panel - the closest regulatory comparables to K181094.
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PROLENE (Polypropylene) 3D Patch
K181268 · Ethicon, Inc. · Jul 2018
ULTRAPRO Mesh and ULTRAPRO ADVANCED
K180910 · Ethicon, Inc. · Jul 2018
PROLENE Polypropylene Mesh Non-Absorbable Synthetic Surgical Mesh, PROLENE (Polypropylene) Hernia System, Non-absorbable Synthetic Surgical Mesh
K180829 · Ethicon, Inc. · Jun 2018