Cleared Special

PROSERIES BIOIMPLANTS-PROANKLE/PROCUFF (K112786) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K112786 · Synovis Orthopedic and Woundcare, Inc. · General & Plastic Surgery device
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Oct 2011
Decision
29d
Days
Class 2
Risk

K112786 is an FDA 510(k) clearance for the PROSERIES BIOIMPLANTS-PROANKLE/PROCUFF. Classified as Mesh, Surgical (product code FTM), Class II - Special Controls.

Submitted by Synovis Orthopedic and Woundcare, Inc. (Irvine, US). The FDA issued a Cleared decision on October 25, 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 878.3300 - 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.

View all Synovis Orthopedic and Woundcare, Inc. devices

Submission Details

510(k) Number K112786 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2011
Decision Date October 25, 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
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 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 162
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