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The Advantage® Turbo Drive System functions as a powered instrument system consisting of handpieces and accessories to perform cutting of soft tissue and bone. The fields of application include Arthroscopic, Foot, Hand, Medial Sternotomy, Neurosurgical, Orthopedic, Otolaryngological, Oral/Maxillofacial, Plastic/Reconstructive and Spinal surgical procedures.

The Advantage® Turbo Drive System device description is identical to the original submission except for the modifications listed below. The modifications described in this Special 510(K) are listed below: 1. A new motor has been installed which provides additional torque and speed to the handpiece. 2. The software, Version 7.0, has been modified to allow Advantage@ Turbo Drive System to run at a maximum forward/reverse speed of 10.000 RMP or 12,000 RPM. This maximum speed is selectable using an appropriate code during the calibration request. All other software parameters used to run the Advantage@ Turbo Drive System operate in the same manner as all pre-existing software versions.

The Perc-D™ SpineWand™ is indicated for ablation, coagulation, and decompression of disc material to treat symptomatic patients with contained herniated discs.

The Wands are bipolar, single use, high frequency electrosurgical devices.

The Symphony Graft Delivery System is indicated for the delivery of allograft, autograft, or synthetic bone graft materials to an orthopedic surgical site. In addition, it is designed to facilitate pre-mixing of bone graft materials with I.V. fluids, blood, plasma, platelet rich plasma, bone marrow or other specific blood component(s) as deemed necessary by the clinical use requirements.

The Symphony Graft Delivery System Syringe is designed specifically to collect, mix and deliver bone graft materials to a surgical site. The Graft Chamber component of the Symphony GDS can be provided either empty or pre-filled with human allograft

To provide power to operate various accessories to cut hard tissue, bone, soft tissue.

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The Aqua Spray is intended for use by Podiatric professionals as an accessory to a burr. The Aqua Spray provides an electric hand piece with an attachment that provides a fine mist of isopropyl alcohol and distilled water (50% concentration) to be dispensed over the burr. The purpose of this mist is to cool the burr and treatment area. In addition, the mist wets the treatment area, thus minimizing the amount of nail dust that becomes airborne during the nail debridement procedure.

The Aqua Spray is an electrically powered accessory to a burr. The Aqua Spray enables a burr to be attached to an electric hand piece capable of 30,000 rpm, in each direction. A small reservoir in which a 50% distilled water and isopropyl alcohol is placed is included in the unit. A small air pump sprays the water/alcohol liquid in a fine mist on the burr. The mist cools the area and prevents nail dust from the treatment area to become airborne.

To be used with the Bone and Marrow Collection System™ (BMCS). The trocar is used to cut and reflect soft-tissue allowing the BMCS to be placed on bone, the suction connector for converting the BMCS into an aspiration handle and the plunger for extruding tissue from the BMCS.

Bone and Marrow Collection System (BMCS) Instrument Kit

To aseptically and efficiently collect osseous and marrow tissue during the drilling of skeletal structures. For the collection of autogenous bone and marrow tissues. For use with the BMCS Instrument Kit to facilitate implantation of autogenous bone and marrow tissue.

Bone and Marrow Collection System (BMCS)

1. Converts Ail Standard Keyed Metal Chuck Head Surgical Drives Into Keyless Chuck Drives.

The device is a simple barrel shaped plastic outer sleeve that is designed in such a way that when it is in place over a standard ¼" metal head orthopaedic chuck, it allows the surgeon or assistant to quickly and easily insert, drive and or remove any size (up to ¼" dia.) orthopaedic bit or pin. The device eliminates the necessity to use the usual chuck key such drives ordinarily require. This feature significantly reduces the chance that a glove could be cut or pinched in the exposed metal gears of the chuck and key. Pin holes in surgical gloves have been shown to a potential source of bacterial and/or viral contamination placing patients and health care providers at risk.