Search Results

The OsteoPlan™ System is intended for use as a software system and image segmentation system for the transfer of imaging information from a medical scanner such as a CT based system. The input data file is processed by the OsteoPlan™ System and the result is an output data file that may then be provided as digital models or used as input to the additive manufacturing portion of the system that produces physical outputs including anatomic models and splints for use in maxillofacial surgery. The OsteoPlan System is also intended as a pre-operative software tool for simulating / evaluating surgical treatment options.

OsteoMed uses computer aided modeling to assist the physician with planning complex maxillofacial surgeries. Specifically, the OsteoPlan™ System provides patient-specific anatomical models, splints, and patient-specific surgical plans and digital files of the surgical plan to assist physicians with maxillofacial surgeries. Outputs of the OsteoPlan™ System are designed with physician input and reviewed by the physician prior to finalization and distribution. All outputs are manufactured by OsteoMed using additive manufacturing (SLS and SLA), only with direct physician involvement to reduce the criticality of the outputs. The system uses electronic medical images of the patient anatomy (CT and CBCT) with input from the physician to create the plan and splints for executing surgery. Off-the-shelf (OTS) software is used for surgical planning. The outputs of the system include Orthognathic Occlusal Splints, Case Reports, and Anatomic models. The splints are offered in commonly used forms, in both intermediate and final positioning, and some are available with ligature holes. Case reports are digital and physical documents created to lay out the surgical plan, dictated by the surgeon, and show outputs of the OsteoPlan™ system that will be used to translate the plan during surgery. Anatomic models are tools provided to physicians for complex anatomy visualization or to preplan surgery with an accurate physical representation of patient anatomy. Anatomic models may include maxilla, mandible, or skull models.

The OsteoMed Mini & Small System Tray is intended to contain Mini and Small implants and surgical instruments for sterilization, storage and handling. The OsteoMed Mini & Small System Tray is suitable for dynamic air removal (pre- vacum) steam sterilization methods. The system tray is not intended to maintain sterlity; it is intended to be used in conjunction with a validated, FDA-cleared sterilization wap in order to maintain sterility of the enclosed devices. The System Tray may also be used in conjunction with a legally marketed rigid container.

The OsteoMed ExtremiFix Mini & Small System Tray is composed of anodized and non-anodized aluminum, stainless steel, silicone, polyethylene terephthalate (Mylar), polyphenylsulfone (Radel), polyamide 11 (nylon), and ZEUS Perfluoroalkoxy (PFA), which are common tray materials, and is used to enclose, protect, and organize OsteoMed ExtremiFix Mini & Small System implants and surgical instruments. This is a product specific sterilization storage system tray (only for use with the OsteoMed ExtremiFix Mini & Small System) that is intended to provide storage for the OsteoMed ExtremiFix screws and accessories during sterilization, storage, and transportation within the hospital environment. The OsteoMed ExtremiFix Mini & Small System Tray is a single sterilization storage system that is comprised of one outer case (base + lid), two screw modules (any two of the four sizes), and two trays (handle tray + instrument tray). The trays are perforated to allow for steam sterilization. An FDA-cleared wrap or FDAcleared rigid sterilization container must be used for sterilization and to maintain the sterility of the contents. The OsteoMed ExtremiFix Mini & Small SystemTray is designed to be used with standard autoclaves used in hospitals and healthcare facilities. As such, the OsteoMed ExtremiFix Mini & Small System Tray is effective for containing the system devices during sterilization and have been designed to withstand repeated steam sterilization cycles.

The Osteomed ExtremiFix Mini & Small Cannulated Screw System is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the device. Screws are intended for single use only.

The OsteoMed Mini & Small Cannulated Screw System is comprised of screws and washers used for bone fixation of the hand and foot following trauma or osteotomy. The System features cannulated screws in the following dimensions: 2.0mm screw diameter - 6 mm to 42 mm screw length; 2.4mm screw diameter - 6 mm to 50 mm screw length; 3.0mm screw diameter - 10 mm to 40 mm screw length; 4.0mm screw diameter - 12 mm to 52 mm screw length; The system instruments include depth gauges, screwdrivers, countersinks, guide wires, and other instruments to facilitate the placement of screws. The implants (screws and washers) of the OsteoMed ExtremiFix Mini & Small Cannulated Screw System are made from titanium alloy (ASTM F136). Modifications to the screws include changing the screw drive connection from a trilobe to a hexalobe and adding a headed screw option for each of the screw size offerings (2.0, 2.4, 3.0, and 4.0 mm diameters). The screws and washers are intended for single use only. The subject device's system instruments include k-wires, drills, countersinks, drivers, tissue protectors, and screw extractor. The instrumentation is made from various grades of stainless steel, anodized aluminum, and/or medical grade polymer. The k-wires, screw extractor, and drills are intended for single use only.

The OsteoMed MMF Sterilization Tray is intended to contain MMF implants and surgical instruments for sterilization, storage and handling. The OsteoMed MMF Sterilization Tray is suitable for dynamic air removal (pre-vacuum) steam sterilization methods. The tray is not intended to maintain sterility; it is intended to be used in conjunction with a validated, FDA-cleared sterilization wrap in order to maintain sterility of the enclosed devices. The sterilization tray may also be used in conjunction with a legally marketed rigid container. Sterilization validation was performed on MMF implants and as surgical instrumentation. Do not exceed a maximum load of 2.3 lbs. in the sterilization tray. Validated sterilization parameters for OsteoMed MMF Sterilization Tray: Method: Steam Cycle Pre-Vacuum Temperature: 270°F (132°C) Exposure Time: 4 minutes Minimum Dry Time: 30 minutes

The OsteoMed MMF Sterilization Tray is composed from a material commonly used (anodized and non-anodized Aluminum) to enclose, protect, and organize OsteoMed's dental non-sterile devices, which meet national or international standards. The OsteoMed MMF Sterilization Tray is intended to provide storage for appropriate dental (MMF) devices and accessories during sterilization, storage, and transportation within the hospital environment. The tray is composed of a base, a lid, and locking latch that secure the device and accessories. The tray is perforated to allow for steam sterilization. An FDAcleared wrap or FDA-cleared rigid sterilization container must be used for sterilization and to maintain the sterility of the contents. The OsteoMed MMF Sterilization Tray is designed to be used with standard autoclaves used in hospitals and healthcare facilities. As such, the OsteoMed MMF Sterilization Tray is effective for containing devices during sterilization and have been designed to withstand repeated steam sterilization cycles.

The OsteoMed ExtremiFix Mid & Large Screw System is indicated for use in bone reconstruction, osteotomy, arthrodesis, and fracture fixation of foot, ankle, and long bones (upper and lower extremity). The screws are intended for single use only. The system drills and guide wires are single use instruments.

The OsteoMed ExtremiFix Mid & Large Screw System is a rigid fixation system consisting of screws in both cannulated and solid versions, all of which are available in various overall and distal thread lengths to accommodate specific patient anatomies. The headed and headless compression screws are made of biocompatible Ti 6-Al 4-V Titanium Alloy. Longer sizes of the single-use only implants are provided individually sterile packed, while the majority of screws and all instruments are provided in modules to allow for customization specific to the surgical indication. The system includes washers for use with 4.5mm, 5.5mm, 6.5mm and 7.0mm headed screws. The washers are made of biocompatible Titanium Alloy. The OsteoMed ExtremiFix Mid & Large Screw System is sterilized in a sterilization tray which is available from OsteoMed.