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Laparoscopic surgical manual instruments are designed to be used endoscopically through cannula to perform cutting, grasping, dissecting, retracting, and manipulating functions. The Ergonomic handle is intended to be used with 5mm inserts available from K&W and previously cleared under K973259.

Symmetry® laparoscopic surgical manual instruments consist of a handle and a 5mm shaft, which hold various 5 mm inserts cleared under K973259. The shaft comes in two lengths: 33 cm and 45 cm. One handle can be used in combination with a variety of different 5 mm inserts. The handles have monopolar posts which allow them to be used for electrosurgery. The ergonomic laparoscopic handles have an adjustable grip. They may be used in one of the three handle positions: pistol grip, hybrid, and inline. To change the handle position, retract the position adjustment button and lock the grip in the chosen position. The handle comes in two sizes.

The Symmetry Sharp Kerrison® Rongeur is indicated for cutting bony tissue of the spine. The Symmetry Sharp Kerrison® Rongeur is a manually operated instrument that consists of a Handle and Tips (available in single use or reusable).

The Symmetry Sharp Kerrison Rongeur is designed to have detachable tips that are disposable. The detachable tips are provided as either sterile single use or as nonsterile reusable tips. The reusable tips must be cleaned and sterilized before use. The sterile, disposable tips are available in 4 cup sizes: (1, 2, 3, and 4 mm); which are identifiable by etchings on each device. The Reusable Tips for the Symmetry Sharp Kerrison® Rongeur Handle are available in 3 cup sizes: (2, 3, and 4 mm); which are identifiable by etchings on each device. The reusable tips have a mating code etched on each pair to ensure that only matched pairs are used. Each tip is designed with a shaft key that fits into its mating slot on the detachable instrument handle. The tip has cups, one within the stationary footplate and the other within the upper sliding shaft, performing the cutting of the bony tissue in the spine area. The various cup sizes within the working tips provide the surgeon various cutting configurations needed for the different characteristics of the bony tissue within the spine. The Symmetry Sharp Kerrison® Rongeur Handle operates with a cup and ball assembly for smooth motion of the footplate when the handle is squeezed. The detachable, reusable instrument handles of this device are provided non-sterile and must be cleaned and sterilized prior to use. The instrument handles are available in three shaft lengths: (5, 6, and 7 inches).

The Symmetry Surgical Quad-Lock® Container System is indicated for use by hospitals and by health care facilities to: · organize and protect stainless steel, aluminum, plastic* and silicone surgical instruments that will be sterilized · allow sterilization of the contained instruments by prevacuum steam, ethylene oxide, and low temperature hydrogen peroxide sterilization cycles (validated modalities and parameters are shown in Table 1) · When sterilized by prevacuum steam sterilization, the Quad-Lock® Containers maintain the sterility of the contents for up to 180 days during storage and transport within the healthcare facility, as long as the integrity of the container has not been compromised · When sterilized by ethylene oxide or low temperature hydrogen peroxide cycle types the Quad-Lock® Containers maintain the sterility of the contents when sterilized by any of the above for up to 30 days during storage and transport within the healthcare facility, as long as the integrity of the container has not been compromised The system has not been tested for maintenance of sterility after transportation outside the health care facility. The system is intended for use with stainless steel, aluminum, plastic and silicone surgical instruments. *The use of plastic instruments has only been confirmed for steam sterilization. For effective sterilization and drying of any size Symmetry Surgical Quad-Lock® Sterilization Container, the recommended maximum combined weight of the single container, lid. basket/tray contents is defined in Table 1. For each cvcle type the qualified lumen size is the minimum length that has been qualified for use are shown in Table 1. Container System Compatibility by Cycle Type details are shown in Table 2.

The Symmetry Surgical Quad-Lock® Container System provides a means to organize and protect stainless steel, aluminum, titanium, plastic and silicone surgical instruments during sterilization and storage. The filter lids, security lids, and container bottoms are made from anodized aluminum. The security lids help ensure sterility during storage and protect the container lid when the containers are stacked. The Container System includes the container base, filter lid, security lid, filters and other accessories.

The Bookwalter Gordon Adjustable Compression Element is indicated for use to provide hemostasis of the femoral vascular access site, during and following catheterization or cannulation procedures.

The Bookwalter Gordon Adjustable Compression Element is an adjustable metal compression device that provides an alternative to applying direct hand pressure to obtain hemostasis during vascular catheterization procedures. The device is secured to a surgical table by means of a compatible clamp which supports an articulating arm that allows positioning of the "metal hand" over the vascular access site. The hand has "fingers" that can be adjusted separately to apply compressive pressure to particular locations around the vascular access site. Once in place the Adjustable Compression Element remains securely in position thereby providing ongoing compression without intervention by the surgical staff although it can be adjusted at any time if so desired. The device is reusable and can be cleaned and sterilized in the hospital setting. The Adjustable Compression Element is constructed of high strength stainless steel for rigidity and durability during use. The system also has an available sterilization container to ensure effective reprocessing.

The Symmetry Kerrison Disposable Tip Rongeurs are indicated for cutting bony tissue of the spine.

The Symmetry Kerrison Disposable Tip Rongeurs are manually operated instruments, provided with a non-sterile reusable handle and a set of sterile, disposable tips, indicated for cutting bony tissue of the spine. They represent a design modification to the predicate devices, the Codman Kerrison Laminectomy Rongeurs and the Integra Kerrison Rongeurs, introducing disposable tips to the device. The Symmetry Kerrison Disposable Tip Rongeurs handles are comprised of stainless steel, and operate with a cup and ball assembly for smooth motion of the footplate when the handle is squeezed. The handles and disposable tips are provided in various sizes to help provide the surgeons with more options.