FTM · Class II · 21 CFR 878.3300

FDA Product Code FTM: Mesh, Surgical

Leading manufacturers include C.R. Bard, Inc., Aziyo Biologics, Inc. and Alafair Biosciences, Inc..

163
Total
163
Cleared
111d
Avg days
1982
Since
Declining activity - 2 submissions in the last 2 years vs 4 in the prior period
Review times improving: avg 62d recently vs 112d historically

FDA 510(k) Cleared Mesh, Surgical Devices (Product Code FTM)

163 devices
1–24 of 163
Cleared Jun 03, 2025
Endoform Reconstructive Template - PLGA
K250598
Aroa Biosurgery , Ltd.
General & Plastic Surgery · 95d
Cleared Dec 19, 2024
OviTex PRS (Long-Term Resorbable)
K243595
TELA Bio, Inc.
General & Plastic Surgery · 29d
Cleared Jun 14, 2024
CanGaroo RM Antibacterial Envelope
K233991
Elutia, Inc.
General & Plastic Surgery · 179d
Cleared May 22, 2024
OviTex PRS
K241126
TELA Bio, Inc.
General & Plastic Surgery · 29d
Cleared Apr 07, 2023
Peri-Guard and Supple Peri-Guard
K223052
Synovis Life Technologies, Inc.
General & Plastic Surgery · 190d
Cleared Mar 21, 2023
OviTex PRS (Long Term Resorbable)
K214070
Tela Bio
General & Plastic Surgery · 449d
Cleared Oct 29, 2021
VersaWrap
K213163
Alafair Biosciences, Inc.
General & Plastic Surgery · 31d
Cleared Oct 27, 2021
PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology
K213125
Synovis Life Technologies. Inc. (A Subsidiary of Baxter
General & Plastic Surgery · 30d
Cleared Jul 14, 2021
Nexo-Gide Bilayer Collagen Membrane
K203496
Geistlich Pharma AG
General & Plastic Surgery · 229d
Cleared Mar 09, 2021
VersaWrap
K203600
Alafair Biosciences, Inc.
General & Plastic Surgery · 90d
Cleared Sep 03, 2020
Lyograft
K192452
B. Bruan Surgical, SA
General & Plastic Surgery · 360d
Cleared Jul 13, 2020
Biodesign Staple Line Reinforcement
K201000
Cook Biotech Incorporated
General & Plastic Surgery · 88d
Cleared Jun 15, 2020
CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large), CanGaroo Enevlope (extra extra large) (SubQ)
K201313
Aziyo Biologics, Inc.
General & Plastic Surgery · 28d
Cleared Mar 06, 2020
VersaWrap Tendon Protector
K200311
Alafair Biosciences, Inc.
General & Plastic Surgery · 29d
Cleared Dec 17, 2019
Peri-Strips Dry with Veritas Collagen Matrix with Secure Grip Technology (PSDV-SG)
K192615
Synovis Life Technologies, Inc. (Baxter International Inc.)
General & Plastic Surgery · 85d
Cleared Oct 21, 2019
CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large), CanGaroo Envelope (extra extra large) (SubQ)
K192616
Aziyo Biologics, Inc.
General & Plastic Surgery · 28d
Cleared Jun 18, 2019
Bovine Pericardial Tissue Patch
K182493
Tisgenx
General & Plastic Surgery · 280d
Cleared Apr 11, 2019
Endoform Restella
K183398
Aroa Biosurgery , Ltd.
General & Plastic Surgery · 125d
Cleared Mar 13, 2019
DePuy Synthes Porous Polyethylene Implants and Titanium Wires Portfolio – MR Conditional
K183472
Synthes USA Products, LLC
General & Plastic Surgery · 89d
Cleared Feb 07, 2019
Gentrix Surgical Matrix, Gentrix Surgical Matrix Hiatal
K182259
Acell, Inc.
General & Plastic Surgery · 170d
Cleared Nov 15, 2018
CanGaroo Neuro Envelope (small)
K182255
Aziyo Biologics, Inc.
General & Plastic Surgery · 87d
Cleared Mar 13, 2018
Biodesign Diaphragmatic Hernia Graft
K171817
Cook Biotech Incorporated
General & Plastic Surgery · 267d
Cleared Feb 23, 2012
COLLAGEN RIBBON
K120019
Wrightmedicaltechnologyinc
General & Plastic Surgery · 51d
Cleared Oct 17, 2008
COLLAMEND FM IMPLANT
K082687
C.R. Bard, Inc.
General & Plastic Surgery · 32d

About Product Code FTM - Regulatory Context

510(k) Submission Activity

163 total 510(k) submissions under product code FTM since 1982, with 163 receiving FDA clearance (average review time: 111 days).

Submission volume has declined in recent years - 2 submissions in the last 24 months compared to 4 in the prior period.

FDA 510(k) Review Time - FTM Product Code

Recent submissions under FTM have taken an average of 62 days to reach a decision - down from 112 days historically, suggesting improved FDA processing for this classification.

FTM devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →