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The Orthosonics OSCAR 3 is intended to be used for cutting and removal of bone and polymethylmethacrylate (PMMA) bone cement in orthopedic applications.

The OSCAR 3 system consists of a generator, 3 handsets, an optional trolley and a range of single use and reusable probes. The generator is effectively an integration of the OSCAR OE3000DB and OSCAR Bone Resector generators. It comprises 3 channels, 2 of which are designed to provide power to the handsets from OSCAR OE3000DB and the third channel is dedicated to provide power to the handset from the OSCAR Bone Resector. The handsets and probes are identical to those of the predicate devices.

The Orthosonics OSCAR Bone Resector is intended to be used for cutting and removal of bone in orthopedic applications.

The OSCAR Bone Resector consists of a power module which generates the ultrasonic energy and provides overall control of the device, a reusable handpiece and a range of single use cutting blades. OSCAR Bone Resector employs longitudinal mode ultrasound in conjunction with a low frequency reciprocating motion to cut and remove bone.

The Orthosonics OSCAR OE3000DB is intended to be used for cutting and removal of bone and acrylic bone cement in orthopedic applications.

The Orthosonics OSCAR OE3000DB consists of a power module which generates the ultrasonic energy and provides overall control of the device, 2 gefferent handsets; one for acrylic bone cement removal and the other for the cutting and removal of bone, and a variety of probes and other accessories. Three independent power modules are mounted in a cart for ease of use.

The Orthosonics OSCAR OE3000 is intended to assist in the removal of polymethylmethacrylate (PMMA) bone cement during arthroplasty revision.

The currently marketed Orthosonics OSCAR Ultrasonic Cement Removal System consists of a power module which generates the ultrasonic energy and provides overall control of the device, a handpiece, and a set of cement removal probes. The primary change to the system is the addition of a laparoscopic video system, which can aid the clinician in examining the inside of the bone that is having its glue removed. This part of the system would only be used when the ultrasound-powered probes are not being used. The laparoscope and optical coupler are currently marketed medical devices. In order to make room for the video module in the main system unit of the OE3000, the ultrasonic power modules were reduced in physical size. In addition, the currently marketed device now has an optional accessory that was added to the system via a letter-to-file, without filing a new 510(k). The change involves adding a "slap hammer" that can be attached to an "extraction" probe, to aid in removal of a PMMA cement plug that is NOT firmly bonded to the endosteal interface. The Extraction Probe to be used with the slap hammer is a modified version of the piercer probe that was cleared with the original 510(k).