. Author manuscript; available in PMC: 2016 Jul 1.

Published in final edited form as: J Biomed Mater Res B Appl Biomater. 2014 Sep 15;103(5):949–959. doi: 10.1002/jbm.b.33286

Table 5.

Standards Used to Gain 510k Clearance for X-Repair^*

ASTM D3786 Standard Test Method for Bursting Strength of Textile Fabrics - Diaphragm Bursting Strength
Tester Method

ASTM D5035 Standard Test Method for Breaking Force & Elongation of Textile Fabrics (Strip Method)

ASTM D5587 Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure

ASTM F1635-11 Standard Test Method for in vitro Degradation Testing of Hydrolytically Degradable Polymer
Resins and Fabricated Forms for Surgical Implants

ASTM F2211 Standard Classification for Tissue Engineered Medical Products (TEMPs)

ASTM F2312 Standard Terminology Relating to TEMPs

ASTM F2027 Standard Guide for Characterization and Testing of Raw or Starting Biomaterials for Tissue-
Engineered Medical Products

ASTM F2150 Standard Guide for Characterization of Biomaterial Scaffolds Used in TEMPs

ISO 10993 Biological Evaluation of Medical Devices

ISO 11135 Sterilization of Health Care Products

X-Repair is a degradable surgical mesh indicated for augmentation of rotator cuff repair that is marketed by Synthasome and received 510k clearance from FDA in 2009.