TESTING

Test Certification Status
Biocompatibility 21 CFR Part 58 Compliance
Good Laboratory Practice for Nonclinical / Lab Studies
ISO 10993-13 tests Passed
Performance testing Biomechanical- static and cyclic loading
USP 39-NF 33:2016 <881> Tensile Strength Passed
Degradation Studies ASTM F1635 Passed
Sterilization Validation ISO 11135 Passed
EO Residuals ISO 11135 Passed
Shelf life -post accelerated aging ASTM F1980 Passed*
Real Time Shelf Life testing ISO 11607 -1:2006 Passed*
Seal Package Validation ASTM F88/F88M-15 Passed
Bubble burst testing ASTM 2096 – 11 Passed
Extraction and Leaching ISO 10993-12 and 10993-18 Passed

*1 year passed

IMG_3622

IMG_3625


zipe-text protects rotator cuff repairs from tendon impingement with its low profile resorbable button

zipe-text vs simple loop tape-like-suture, weak rubber

zipe-text vs vs horizontal mattress tape-like/suture, weak rubber

zipe-text vs double row strong rubber

Rip-Through comparison
Gap Formation comparison

ZipE® Augmentation Graft Fixation and Dynamic Image Capture Comparison
ZipE® Augmentation Graft Fixation and Dynamic Image Capture Comparison

ZipE® Contact Pressure and Area Comparisons
ZipE® Contact Pressure and Area Comparisons