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The Ace Connex™ Pre-Sutured Fascia is intended for use as a component in soft tissue surgical procedures where constructs including those with allograft tissues are used for reconstruction, replacement, or augmentation of the hip labrum.

The Labrum Replacement and Augmentation Device, marketed as AceConnex™ Pre-Sutured Fascia subject device is a pre-assembled surgical construct comprised of allograft tissue and non-absorbable, synthetic suture. The allograft fascia lata tissue is terminally cleaned and disinfected using a proprietary process. The fascia lata tissue is pre-sutured with Force Fiber® ultra-high molecular weight polyethylene (UHMWPE) non-absorbable surgical suture cleared under K063778, and the device is terminally sterilized by low dose electron beam irradiation. The device has a smooth side for articulating against the rotating cartilage surface and a sutured side which is secured against the bone and comes in three sizes to accommodate the needs of surgeons performing segmental (40-60mm and 60-100mm) and full circumferential (100-140mm) augmentations or reconstructions. Each device contains two adjustable sections where the device may be cut to provide adjustment options so that the device may be trimmed to fit the needs of patient and surgeon.

Pre-sutured allograft tendons are intended for use as a construct in anterior cruciate ligament and posterior cruciate ligament reconstruction.

This device consists of a combination of tendons that have been cleaned and disinfected using a proprietary process. The tendons are pre-sutured and terminally sterilized by low dose electron beam irradiation. The device may include anterior tibialis, posterior tibialis, peroneus longus, semitendinosus and/or gracilis tendons and is pre-sutured with Force Fiber UHWMPE nonabsorbable surgical suture. Through a contractual agreement with Teleflex Medical, AlloSource has the license rights to manufacture pre-sutured tendons using their UHMWPE non-absorbable surgical suture cleared 15-Sept-2009 under pre-market clearance K092533. All products are provided sterile and for single patient use.

For orthopedic use, AlloFuse Plus Paste and Putty are intended for use as an autograft extender (i.e. extremities, posterolateral spine and pelvis) and as a bone void filler (i.e. extremities and pelvis) for bony voids or gaps that are not intrinsic to the stability of the bony structure. The AlloFuse Plus products are indicated to be packed gently into bony defects of the skeletal system. These defects may be surgically created or from the result of traumatic injury to the bone.

AlloFuse Plus is derived from selected donated human bone tissue that has been processed into particles. The bone particles are subsequently demineralized using a hydrochloric acid process. The demineralized bone matrix (DBM) is combined with a reverse phase carrier, cancellous chips from the same donor and formulated into a paste or putty-like consistency. The carrier is a solution of polvethylene oxide polypropylene oxide block copolymer dissolved in water exhibiting reverse phase characteristics (i.e. an increase in viscosity as temperature increases).

AlloFuse is indicated for orthopedic applications as filler for gaps or voids that are not intrinsic to the stability of the bony structure. AlloFuse® is indicated to be packed gently into bony gaps in the skeletal system as a bone graft extender (extremities, spine, and pelvis) and as bony void filler of the extremities and pelvis. These defects may be surgically created or from the result of traumatic injury to the bone.

AlloFuse is derived from selected donated human bone tissue that has been processed into particles. The bone particles are subsequently demineralized using a hydrochloric acid process. The demineralized bone matrix (DBM) is combined with an inert reverse phase carrier and formulated into a gel or putty-like consistency. The carrier is a solution of polyethylene oxide polypropylene oxide block copolymer dissolved in water exhibiting reverse phase characteristics (i.e. an increase in viscosity as temperature increases).