STERILE TENDONS

Safety, Tissue Integrity & Sterilization

REGULATORY COMPLIANCE: FDA AATB CLIA ISO

Advanced Cleansing Technologies Cleanse While Preserving Tissue Integrity

Tissue integrity is maintained with consistent processing, monitored temperature and limited reagent exposure.

Our processors use a proprietary bioburden reduction step that removes blood and lipids.

Terminal Sterilization Without Compromising Tissue Performance

Recent studies show low dose, low-temperature irradiation does not impact the integrity of tissue and post-transplant failure rates.1,2

JRF Ortho Tendons have a Sterility Assurance Level (SAL) of 10–6, obtained by using low dose, low temperature irradiation.

Our processors are pioneers in low dose irradiation sterilization for allograft tissue.3

Maximizing Safety While Providing Quality Tendons

Working in a controlled environment with patented processes and low dose, low-temperature sterilization, our processors’ skilled technicians deliver safe, high quality tendons.

Utilizing highly sensitive NAT testing has resulted in no confirmed incidence of disease transmission.

* All-Inside® , FiberLoop®, FiberWire®, GraftLink®, SpeedGraft®, TigerLoop®, TightRope® and Versagraft® are trademarks of Arthrex, Inc.
1. McGilvray KC, Santoni BG, Turner AS, Bogdansky S, Wheeler DL, Puttlitz CM. The effects of 60Co gamma radiation dose on initial structural biomechanical properties of ovine bone-patellar tendon-bone allografts. Cell and Tissue Bank. 2011. (12):89-98.
2. Block JE. The impact of irradiation on the microbiological safety, biomechanical properties, and clinical performance of musculoskeletal allografts. Orthopedics. 2006. (11):991-6.
3. TIR37:2007: Sterilization of Health Care Products – Radiation – Guidance on Sterilization of Human Tissue-Based Products.

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