Cleared Special

K060989 - TISSUEMEND SOFT TISSUE REPAIR MATRIX

K060989 is an FDA 510(k) clearance for TISSUEMEND SOFT TISSUE REPAIR 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.

K060989 · Tei Biosciences, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2006
Decision
35d
Days
Class 2
Risk

K060989 is an FDA 510(k) clearance for the TISSUEMEND SOFT TISSUE REPAIR 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 May 15, 2006 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 - K060989

510(k) Number K060989 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 2006
Decision Date May 15, 2006
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
Combination Product No
PCCP Authorized No
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 152
Devices cleared under the same product code (FTM) and FDA review panel - the closest regulatory comparables to K060989.
ZIMMER COLLAGEN REPAIR PATCH
K053562 · Tissue Science Laboratories, Plc · Jun 2006
COSMATRIX
K060829 · Tei Biosciences, Inc. · May 2006
XENFORM SOFT TISSUE REPAIR MATRIX
K060984 · Tei Biosciences, Inc. · May 2006
BIOBLANKET SURGICAL MESH
K061030 · Kensey Nash Corporation · May 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