Biocompatibility21 CFR Part 58 Compliance
Good Laboratory Practice for Nonclinical / Lab Studies
ISO 10993-13 testsPassed
Performance testingBiomechanical- static and cyclic loading
USP 39-NF 33:2016 <881> Tensile StrengthPassed
Degradation StudiesASTM F1635Passed
Sterilization ValidationISO 11135Passed
EO ResidualsISO 11135Passed
Shelf life -post accelerated agingASTM F1980Passed*
Real Time Shelf Life testingISO 11607 -1:2006Passed*
Seal Package ValidationASTM F88/F88M-15Passed
Bubble burst testingASTM 2096 – 11Passed
Extraction and LeachingISO 10993-12 and 10993-18Passed

*1 year passed



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

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zipe-text vs double row strong rubber

Rip-Through comparison
Gap Formation comparison

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