Stryker Howmedica Osteonics Receives FDA Clearance for Simplex P With Tobramycin Antibiotic Bone Cement
KALAMAZOO, Mich. -- Stryker Corporation announces that its orthopaedic implant division, Stryker Howmedica Osteonics, received clearance from the Food and Drug Administration (FDA) to begin marketing and selling Simplex P with Tobramycin Bone Cement in the United States.
Simplex P with Tobramycin Bone Cement represents a combination of the most popular bone cement in the U.S., Simplex P Bone Cement, with U.S. orthopaedic surgeons' No. 1 choice in antibiotic, Tobramycin. The introduction of Simplex P with Tobramycin Bone Cement marks the first time Stryker Howmedica Osteonics has offered a medical device and pharmaceutical combined in one cleared product offering in the U.S.
There has been strong demand for a pre-blended antibiotic bone cement in the U.S. orthopaedic community by surgeons who prefer to mix antibiotics into bone cement for at-risk patients. The clearance of Simplex P with Tobramycin Bone Cement will provide a reliable and regulated method for meeting this demand for patients undergoing a second stage of a two-stage revision for a total joint procedure following the elimination of an active infection.
Stryker Howmedica Osteonics' predicate device, Simplex P Bone Cement, is the No. 1 selling bone cement in the U.S. and has been used worldwide for more than 40 years. Bone cement is used for the fixation of an implant to bone and aids in transmitting force from the implant to the surrounding bone. More than 640,000 hip and knee replacements are performed in the United States each year. Bone cement is a necessary component in over 80 percent of all total knee replacements and over 50 percent of hip replacements.
Stryker Corporation develops, manufactures and markets specialty surgical and medical products worldwide, including reconstructive implants, spinal, trauma and craniomaxillofacial systems, the bone growth factor osteogenic protein-1, powered surgical instruments, endoscopic and surgical navigation systems and patient care and handling equipment and provides outpatient physical therapy services in the United States.
Source: Stryker Corporation
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