Profile: TMJ Concepts manufactures patient-fitted prostheses for the reconstruction of temporomandibular joints. Our glenoid fossa is a hip acetabular socket prosthesis, which is made of pure titanium mesh. It has an articular surface of medical grade polyethylene. Our patient-fitted implants are made with materials that have been used to make hip and knee prostheses. The body of the condylar component is made of medical grade titanium alloy.
FDA Registration Number: 2031049
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• Acetabular Mesh Hip Prosthesis (FDA Code: JDJ / 878.3300) Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery. |
• Orthopedic Manual Surgical Instrument (FDA Code: LXH / 888.4540) An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill brace, broach, burr, corkscrew, countersink, pin crimper, wire cutter, prosthesis driver, extractor, file, fork, needle holder, impactor, bending or contouring instrument, compression instrument, passer, socket positioner, probe, femoral neck punch, socket pusher, reamer, rongeur, scissors, screwdriver, bone skid, staple driver, bone screw starter, surgical stripper, tamp, bone tap, trephine, wire twister, and wrench. |
• Temporomandibular Joint Reconstruction Prostheses |