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The Resofix® Bioabsorbable Expansion Bolt is a single-use, sterile implant that is intended for use in the interference fixation of bone-tendon-bone and soft tissue grafts in anterior and posterior cruciate ligament reconstruction.

The Resofix product is a two-shell bioabsorbable expansion bolt, consisting of two shell halves, forming an expanding dowel system, and a central expansion wedge. Insertion of the expansion wedge between the dowel halves results in expansion over the full length of the implant. When expanded, 2/3 of the implant cross-section is round and 1/3 is flat. The surface of the implant is designed to maximize contact and maintain implant position, both immediately after being inserted, as well as during the absorption period. The Resofix® Bioabsorbable Expansion Bolt shell halves and expansion wedge are injection molded poly-D,L-lactide (PDLLA, Resomer 208), which is substantially equivalent to the material used by Sulzer Orthopedics Ltd. in its Sysorb interference screws, previously approved by the U.S. FDA (K983592). Included in the system are associated preparation and implantation instruments, which are exempt Class I instruments, per 21 CFR 888.4540, "Orthopaedic Manual Surgical Instruments". The Resofix PDLLA implants are available in two sizes (8mm x 28mm and 10mm x 35mm) and the 10mm units are available in two expansion options (2.2mm for bone-tendon-bone grafts and 2.9mm for semitendinosus gracilis grafts).