Implant

STERILITY OF TMJ IMPLANT COMPONENTS

The TMJ mandibular and glenoid fossa components are packaged in double Tyvek/film pouches and have been sterilized using an ethylene oxide gas cycle that has been shown to produce terminally sterile product with a sterility assurance level of 10-6 and residual levels below ANSI/AIMI/ISO 10993-7 limits and FDA proposed limits.

DO NOT USE COMPONENTS IN OPEN OR DAMAGED PACKAGING.

DO NOT STEAM STERILIZE THE GLENOID FOSSA COMPONENT AS DAMAGE TO THE PLASTIC PORTION MAY OCCUR.

STERILIZATION INSTRUCTIONS FOR SCREWS

The screws are intended for steam sterilization in the TMJ Fixation Hardware Sterilization Case provided by TMJ Concepts. The following sterilization cycle has been shown to produce terminally sterile product with a sterility assurance level of 10-6. Other similar steam cycles may be used but have not been evaluated.

Wrapped or Unwrapped Prevacuum Steam Sterilization,
15 minutes at 270-275°F (133-135°C)