Cleared Abbreviated

K060829 - COSMATRIX

K060829 is an FDA 510(k) clearance for COSMATRIX, manufactured by Tei Biosciences, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FTM cleared through the Abbreviated 510(k) pathway after a 51-day FDA review.

K060829 · Tei Biosciences, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2006
Decision
51d
Days
Class 2
Risk

K060829 is an FDA 510(k) clearance for the COSMATRIX. 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 May 17, 2006 after a review of 51 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 - K060829

510(k) Number K060829 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 2006
Decision Date May 17, 2006
Days to Decision 51 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
64d faster than avg
Panel avg: 115d · This submission: 51d
Pathway characteristics
Standards-based clearance path.

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 K060829.
SURGISIS, SURGISIS ES
K062696 · Cook Biotech, Inc. · Oct 2006
SURGISIS RVP RECTO-VAGINAL FISTULA PLUG
K062729 · Cook Biotech, Inc. · Oct 2006
SURGISIS PEYRONIE'S REPAIR GRAFT, MODEL SPR-100
K062320 · Cook Biotech, Inc. · Oct 2006
BARD COLLAMEND IMPLANT, MODELS 1175101, 1175102, 1175103, 1175104, 1175105
K052322 · C.R. Bard, Inc. · Apr 2006
TENDON WRAP TENDON PROTECTOR
K053655 · Integra LifeSciences Corporation · Feb 2006
SYNTHES (USA) POROUS POLYETHYLENE IMPLANTS
K051879 · Synthes (Usa) · Oct 2005