Clinical Indications: OsteoMed Foot Plating System is intended for use in trauma, general surgery and reconstructive procedures of the lower extremity or other bones appropriate for the size of the device. The OsteoMed Foot Plating System implants are intended for single use only. The plates are made from: titanium (ASTM F67) or titanium-alloy (ASTM F136 or F1472). Screws are made from titanium-alloy (ASTM F136). The instrumentation is made from various grades of stainless steel, anodized luminum, and/or medical grade polymers.
Use of the OsteoMed Foot Plating System is contraindicated in the following cases:
• Active or suspected infection, or in patients who are immunocompromised;
• Patients previously sensitized to titanium or stainless steel;
• Patients with certain metabolic diseases;
• Patients exhibiting disorders which would cause the patient to ignore the physician’s pre- and/ or post-operative instructions and limitations of internal rigid fixation implants;
• Percutaneous K-wire placement is contraindicated in cases of displaced fractures and compressed fractures;