Cleared Traditional

K183472 - DePuy Synthes Porous Polyethylene Impla...

K183472 is the FDA 510(k) clearance for DePuy Synthes Porous Polyethylene Impla... by Synthes USA Products, LLC. It is a Class 2 General & Plastic Surgery device (product code FTM) cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K183472 · Synthes USA Products, LLC · General & Plastic Surgery device
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Mar 2019
Decision
89d
Days
Class 2
Risk

K183472 is an FDA 510(k) clearance for the DePuy Synthes Porous Polyethylene Implants and Titanium Wires Portfolio – MR .... Classified as Mesh, Surgical (product code FTM), Class II - Special Controls.

Submitted by Synthes USA Products, LLC (West Chester, US). The FDA issued a Cleared decision on March 13, 2019 after a review of 89 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Synthes USA Products, LLC devices

Submission Details

510(k) Number K183472 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 2018
Decision Date March 13, 2019
Days to Decision 89 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
26d faster than avg
Panel avg: 115d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FTM Mesh, Surgical
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 - FTM Mesh, Surgical

All 44
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