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The IntelliSense Drill is intended to bore a hole into bone for insertion of a screw, wire, cable, plate, pin, bolt, etc. In Bicortical mode, the IntelliSense Drill is indicated to be used in bicortical long bone, such are the fibri, fiber, fibel, f.but, f.but, humerus, ulna, and radius.

The IntelliSense Drill device will contain a drill unit (with attached cable), Control Console, and Sterilization Tray. Proprietary Drill Bits and Drill Bit Bushing will be sold separately as accessories. The drill bits and companion bushings are sold as a pair and are disposable (single-procedure). The IntelliSense Drill's design combines the drilling and depth measurement processes into one procedure, which determines drill bit location. By monitoring the load placed upon the drilling mechanism, the precise location of the drill bit may be determined relative to the bone. Secondary depth monitoring will provide the measurement of the drill bit depth and appropriate screw size.

Ortho Solutions sterile drill bits are intended to bore a hole into bone for insertion of a screw, wire, cable, plate, pin, bolt, etc.

All Ortho Solutions Sterile Single-Use Drills Bits are manufactured from common Stainless Steel materials that are either cold-worked or heat treated for hardness cutting durability and for corrosion resistance. Ortho Solutions sterile drill bits are available in various sizes and lengths, have a fluted design, and are either in a solid or cannulated form and may be calibrated. The Ortho Solutions drill bits have various end coupling mechanisms. Ortho Solutions drill bits will be provided to the user 'sterile'. Gamma Radiation will be used to sterilize the device.

Anspach Surgical Irrigation Systems are indicated for use with Anspach Surgical Motor Systems for providing controlled, cooling irrigation during cutting, shaping and removal of bone, including bones of the skull and spine.

The Anspach Irrigation Pump System is a stand-alone pump and pump control system, designed to deliver a constant flow of irrigation fluid by means of a peristaltic pump. The Irrigation Tube, (the subject of this submission), is a fluid delivery device that functions as a component of the irrigation system, to draw fluid from a standard IV bag to a 1/16" OD accessory for delivery to the operating site. Tubing size determines the available flow range for the system, while the pump RPM determines the specific flow rate within that range.

The Explant® Osteonecrosis Intervention Implant Removal Kit is intended for removal of a Trabecular Metal™ Osteonecrosis Intervention Implant.

The instruments are supplied sterile in a preassembled kit. Two size kits are available; a 10mm ID kit and a 14mm ID kit. The 10mm kit cannot be used alone and must be used in combination with the 14mm kit. The instrument come preassembled to Zimmer Hudson Fitting Adaptors, allowing the Tubes to be driven via a Zimmer T-Handle or a Zimmer Power Driver. The Hudson fittings can be removed to expose a through-hole at the end of the tube to allow for removal of a specimen that remains in the coring tube. All components of these kits are single use only.

The Synthes Electric Pen Drive (EPD) System is indicated for screw insertion, pin and wire placement, cutting of bone and metal, drilling, reaming, decorticating, shaping and smoothing of bones and teeth in a wide variety of surgical procedures, including but not limited to general orthopedic trauma, foot, hand, maxillofacial, neurosurgical, oral, otolaryngological, reconstructive and spine surgery.

The Synthes Electric Pen Drive System consists of a console, handpieces, attachments, footswitch, and cutting tools. The console is connected to the mains by an electric cord, and includes connectors for the handpieces and the footswitch, as well as speed controls, torque limiting feature, and irrigation pump. The handpieces are pen-shaped, and will be available in two versions: 60,000 rpm and 90,000 rpm. The handpieces are connected to the console via a sterilizeable cord. The rotation speed of the motor can be controlled via the footswitch or a removable handswitch. Multiple attachments are available that have a quick-connect into the handpieces; these attachments accept various cutting tools, including drill bits, burrs and saw blades.

Arthroscopic blades and burs are indicated for resection of tissue within joint spaces under arthroscopic control.

Reprocessed Used Disposable Arthroscopic Blades and Burs are single use surgical devices used for resection of tissue within joint spaces under arthroscopic control. MDS Reprocessed Stryker and Dyonics Disposable Arthroscopic Blades Burs are composed of the same materials as currently marketed hand-manipulated Stryker and Dyonics Disposable Arthroscopic Blades/Burs sold new.

Blades, burs, bits and taps are metal accessories and attachments used with powered surgical tools for re-constructive and traumatic bone surgery. AMI intends to reprocess all brands of used disposable surgical saw blades, burs, bits and taps. Reprocessing includes all the steps performed to make a contaminated single use device patient ready. Only blades, burs, bits and taps that are currently sold on the market (which have met premarket requirements by the original manufacturer for single use) will be reprocessed by AMI.

AMI intends to market used disposable surgical blades, burs, bits and taps that have been reprocessed. Reprocessing blades, burs, bits and taps is performed by AMI to AMI protocol Number 40014. "Reprocessed," means all operations performed to render a contaminated singleuse device patient ready (Enforcement Priorities for Single-Use Devices Reprocessed by Third Party Reprocessors and Hospitals). AMI is a "third party reprocessor" and reprocesses used single-used medical devices. Used blades, burs, bits and taps that do not meet the AMI protocol are rejected. Rejection may occur during the first reprocessing (in which the item is not reprocessed at all) or anytime during subsequent reprocessings. AMI believes that used single-use blades, burs, bits and taps can be considered "reusable" as defined in the Food and Drug Administration Compliance Policy Guide #7124: they are able to withstand the necessary cleaning and sterilization process, the physical characteristics or quality of the device will not be adversely effected, and the device remains safe and effective for its intended use. Blades, burs, bits and taps are metal accessories and attachments used with powered surgical tools for re-constructive and traumatic bone surgery. AMI reprocessed blades, burs, bits and taps are composed of the same materials as currently marketed blades, burs, bits and taps sold new. Only blades, burs, bits and taps that are currently sold on the market (which have met premarket requirements by the original manufacturer for single use) are reprocessed by Adven Medical, Inc.

Arthroscopic blades and burs are indicated for resection of tissue within joint spaces under arthroscopic control.

Arthroscopic blades and burs are single use instruments consisting of several tubes and designs. The inner blade rotation is driven by a motor. AMI intends to reprocess arthroscopy blades and burs. Reprocessing includes all the steps performed to make a contaminated single use device patient ready. Only dispossible, non angled arthroscopy blades and burs manufactured by Dyonics and Stryker, that are currently sold on the market (which have met premarket requirements by the original manufacturer for single use) will be reprocessed by AMI.

The AV Core System is a system of cannulated trephines and drills used to obtain and insert a contoured bone graft into a matched hole in the femoral head. The use of the system is indicated for patients suffering from Avascular necrosis, in which the head does not suffer from collapse or degenerative changes.

The AvCore System comprises of a series of trephines and purchased canulated drill bits of matched size, used to obtain a appropriate sized and contoured bone graft in the treatment of avascular necrosis of the femoral head. The device is classified under the nomenclature of drills, burs, Trephines & accessories ( compound, powered). The product code is 84HBF and regulation number 882:4305 and is a Class II device.

Aesculap's HilLan Motor System is a high-speed pneumatic motor system intended for use in surgical procedures to drive handpieces which cut and shape bone. It is indicated for use in orthopedics, spine, and plastic/reconstructive (i.e. maxillofacial and craniofacial) procedures.

The Hillan Pneumatic Motor System consists of a small hand held motor, an air hose, a foot control, a pneumatic motor hose, and various handpieces. The system components connect to each other via a proprietary coupling system.