Cleared Abbreviated

K051766 - ORTHOMEND

K051766 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 42-day FDA review.

K051766 · Tei Biosciences, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2005
Decision
42d
Days
Class 2
Risk

K051766 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 August 11, 2005 after a review of 42 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 - K051766

510(k) Number K051766 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 2005
Decision Date August 11, 2005
Days to Decision 42 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
73d faster than avg
Panel avg: 115d · This submission: 42d
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 K051766.
GORE SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL
K053200 · W.L. Gore & Associates, Inc. · Dec 2005
BARD LARGE PORE SOFT MESH AND SOFT MESH PRESHAPED
K052155 · C.R. Bard, Inc. · Oct 2005
VICRYL * MESH BAG
K051701 · Ethicon, Inc. · Sep 2005
PARIETEX COMPOSITE PCO-OS AND PCO-OB MESHES
K050187 · Sofradim Production · Feb 2005
GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL
K043056 · W.L. Gore & Associates, Inc. · Dec 2004
GORE POLYPROPYLENE HERNIA MESH
K043081 · W.L. Gore & Associates, Inc. · Dec 2004