Cleared Special

K112786 - PROSERIES BIOIMPLANTS-PROANKLE/PROCUFF

K112786 is an FDA 510(k) clearance for PROSERIES BIOIMPLANTS-PROANKLE/PROCUFF, manufactured by Synovis Orthopedic and Woundcare, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FTM cleared through the Special 510(k) pathway after a 29-day FDA review.

K112786 · Synovis Orthopedic and Woundcare, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K112786

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 115d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

FTM Device Classification - Class 2, Special Controls

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 156
Devices cleared under the same product code (FTM) and FDA review panel - the closest regulatory comparables to K112786.
SYNERGY TISSUE MATRIX
K113460 · Synovis Orthopedic & Woundcare · Jan 2012
PROPATCH SOFT TISSUE REPAIR MATRIX
K110581 · Cryolife, Inc. · Jan 2012
COLLAGEN TENDON SHEET
K112423 · Rotation Medical, Inc. · Dec 2011
PORCINE SURGICAL MESH, PORCINE DERMAL MATRIX
K111436 · Brennen Medical, LLC · Oct 2011
XYLOS MACRO-POROUS SURGICAL MESH
K111584 · Xylos Corporation · Aug 2011
BIODESIGN NIPPLE RECONSTRUCTION CYLINDER
K110402 · Cook Biotech, Inc. · Jun 2011
K112786 · PROSERIES BIOIMPLANTS-PROANKLE/PROCUFF
Download PDF FDA Summary Synovis Orthopedic an…