Cleared Special

K071807 - ORTHOMEND SOFT TISSUE MATRIX

K071807 is an FDA 510(k) clearance for ORTHOMEND SOFT TISSUE MATRIX, manufactured by Tei Biosciences, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FTM cleared through the Special 510(k) pathway after a 35-day FDA review.

K071807 · Tei Biosciences, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2007
Decision
35d
Days
Class 2
Risk

K071807 is an FDA 510(k) clearance for the ORTHOMEND SOFT TISSUE MATRIX. Classified as Mesh, Surgical (product code FTM), Class II - Special Controls.

Submitted by Tei Biosciences, Inc. (Boston, US). The FDA issued a Cleared decision on August 6, 2007 after a review of 35 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 Tei Biosciences, Inc. devices

FDA 510(k) Submission Details - K071807

510(k) Number K071807 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 2007
Decision Date August 06, 2007
Days to Decision 35 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
80d faster than avg
Panel avg: 115d · This submission: 35d
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 67
Devices cleared under the same product code (FTM) and FDA review panel - the closest regulatory comparables to K071807.
SURGISIS BIODESIGN TISSUE GRAFT
K073391 · Cook Biotech, Inc. · Mar 2008
MODIFICATION TO SURGISIS SLR STAPLE LINE REINFORCEMENT
K070405 · Cook Biotech, Inc. · Oct 2007
DEPUY RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT
K071016 · DePuy Orthopaedics, Inc. · Sep 2007
MESOSFOL SURGICAL FILM
K062558 · Biomet Manufacturing Corp · Jun 2007
SIS FACIAL CYLINDER, SIS FACIAL IMPLANT
K070738 · Cook Biotech, Inc. · Apr 2007
BARD COLLAMEND IMPLANT, MODELS 1175102, 1175103, 1175104, 1175105, 1175106
K063178 · C.R. Bard, Inc. · Nov 2006