Cleared Abbreviated

K031188 - ORTHOMEND

K031188 is an FDA 510(k) clearance for ORTHOMEND, manufactured by Tei Biosciences, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FTL cleared through the Abbreviated 510(k) pathway after a 73-day FDA review.

K031188 · Tei Biosciences, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2003
Decision
73d
Days
Class 2
Risk

K031188 is an FDA 510(k) clearance for the ORTHOMEND. Classified as Mesh, Surgical, Polymeric (product code FTL), Class II - Special Controls.

Submitted by Tei Biosciences, Inc. (Boston, US). The FDA issued a Cleared decision on June 27, 2003 after a review of 73 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Tei Biosciences, Inc. devices

FDA 510(k) Submission Details - K031188

510(k) Number K031188 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 2003
Decision Date June 27, 2003
Days to Decision 73 days
Submission Type Abbreviated
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 115d · This submission: 73d
Pathway characteristics
Standards-based clearance path.

FTL Device Classification - Class 2, Special Controls

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 Peers - FTL Mesh, Surgical, Polymeric

All 200
Devices cleared under the same product code (FTL) and FDA review panel - the closest regulatory comparables to K031188.
GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL
K032865 · W.L. Gore & Associates, Inc. · Nov 2003
PROCEED TRILAMINATE SURGICAL MESH
K031925 · Ethicon, Inc. · Sep 2003
GORE-TEX DUALMESH EMERGE PLUS BIOMATERIAL
K032168 · W.L. Gore & Associates, Inc. · Aug 2003
V.A.C. ABDOMINAL DRESSING
K022011 · Kinetic Concepts, Inc. · Feb 2003
SMALL BARD VENTRALEX PATCH
K024008 · C.R. Bard, Inc. · Feb 2003
DUALMESH EMERGE & EMERGE PLUS BIOMATERIAL
K022782 · W.L. Gore & Associates, Inc. · Sep 2002