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Taps are nonpowered hand-held devices intended for bone cutting and drilling on a patient's skull during fracture repair and reconstructive procedures of the cranium. The taps may be used to prepare cranial bone to insert bone fixation screws.

Taps are used to drill a hole and simultaneously create threads in order to accommodate a Rapid Resorbable Fixation System bone screw. The self-drilling fixed-stop taps are manufactured from Stainless Steel 440A which conforms to ASTM F899 Standard Specification for Stainless Steel for Surgical Instruments and ASTM A276 Specification for Stainless Steel Bars and Shapes. The adjustable-length taps (final assembly) are assembled from three components; the adjustable tap (Stainless Steel 440A), the locking collar (Makrolon Rx2530 W/1118 Tint), and the stop collar (Stainless Steel 316L with an aluminum titanium nitride coating).

The DSG™ Zavation Screw System is indicated for use with the Zavation Spinal System during pedicle screw insertion to provide feedback to the surgeon via visual and audible alerts that indicate a change in impedance at the tip of the pedicle screw and may indicate contact of the tip with soft tissues and possible vertebral cortex perforation. The DSG™ Zavation Screw System is indicated for use in both open and percutaneous (MIS) surgical approaches to the spine, with options of direct insertion of the screw in bone or after a step of preparation of the pilot hole with sensor equipped instruments.

The DSG™ Zavation Screw System is a modification to the cleared DSG™ Threaded Drill System and consists of the DSG™ Electronic T-handle, Ratcheting Handle, DSG™ Pin (active stylet), and the previously cleared Zavation Spinal System (K153404). These components are purchased and shipped as a complete system from Zavation, with the DSG™ Threaded Drill System components and Zavation Spinal System components individually packaged. The complete system is provided with the modified instructions for use of the DSG™ Zavation Screw System. All of the patient-contacting materials are categorized per FDA's guidance on ISO 10993-1 as externally communicating materials that are in contact with the body for a limited duration, and are unchanged from the prior clearance. Certain components of the device are single-use while others are re-usable; certain components are provided sterile while others are sterilized by the end user. The device is intended for use by surgeons in a professional healthcare environment, and utilizes sensing technology to detect the impediately surrounding tissues while inserting pedicle screws either through a previously drilled pilot hole or directly into bone. The surgeon can either drill and/or tap the screw hole prior to inserting the pedicle screw, or can use the system to directly insert the screw into the bone without a pilot hole. As the screw is manually advanced into the bone, the distal sensor measures the electrical impedance of the immediately surrounding tissues. The device produces real-time visual and audible signals to indicate changes in impedance associated with possible vertebral perforation.

The MRII Cranial Drill and Accessories are intended to provide access through the skull for ventriculostomy or other neurological procedures, such as biopsy or catheter placement, in or near an MR scanner of 3T maximum strength. The MRII Cranial Drill and Accessories are intended to be used only when the scanner is not performing a scan. The MRII Cranial Drill is intended for single use only.

The MRII Cranial Drill and accessories is composed of the MR Compatible Hand Drill and Drill Bit Kits, packaged separately and found substantially equivalent in K 122456. The packaging is identical to that of the predicate device. The MRII Cranial Drill is wrapped in CSR and then sealed in a Tyvek pouch. The Drill Bit Kits are packaged in a sealed tray within a sealed Tyvek pouch.

The SmartTwist™ MRII Hand Drill and accessories are intended to provide access through the skull for ventriculostomy or other neurological procedures, such as biopsy or catheter placement, in or near an MR scanner of 3T maximum strength. The SmartTwist MRII Hand Drill and accessories are intended to be used only when the scanner is not performing a scan. The SmartTwist MRII Hand Drill is intended for single use only.

The SmartTwist MRII Hand Drill is a hand held manual drill with a 3:1 gear ration. It is intended for use with the drill kit accessory kits SmartTip Drill Kits for a 3.2mm, 4.5mm and 6.0mm drill bit, with lancet, depth stop and ruler.

The MRII Cranial Drill and accessories is intended to provide access through the skull for ventriculostomy or other neurological procedures, such as biopsy or catheter placement, in or near an MR scanner of 3T maximum field strength. The MRII Cranial Drill and accessories are intended to be used only when the scanner is not performing a scan. The MRII Cranial Drill is intended for single use only.

The MRII Cranial Drill is a hand held manual drill with a 3:1 gear ration. It is in intended for use with the drill kit accessory kits consisting of a 2.0 or 3.2 mm drill bit, lancet, depth stop and ruler.

The Medical Designs Hand Drill is intended for use in Neurosurgical procedures and for use with Medical Designs' Subdural Evacuating Port System Kit (S.E.P.S), Catalog # 11-9901. The Hand Drill is not intended for any use other than that indicated.

The hand drill consists of a black ABS plastic housing, glass filled nylon handle and ABS plastic handle knob. The hand drill has lubricated aluminum gears and a ¼" spring loaded, chrome plated steel, 3-jaw chuck assembly. The hand drill is a single-use disposable device. It is sterilized using gamma radiation.

The FrameLock™ is indicated for otorhinolaryngological and head/neck surgery where any medical condition in which the use of stereotactic surgery may be appropriate, and where a reference to a rigid anatomic head or neck structure, such as the skull, vertebrae, intranasal area, or sinus, can be identified relative to a CT or MR based model of the anatomy.

The LandmarX™ FrameLock™ kit is an optional accessory of the LandmarX Image Guided Surgical System, previously cleared in K992927. The LandmarX™ FrameLock™ kit is designed to provide a safe, reliable, compact, and minimally invasive means of direct and rigid fixation to the patient's skull for the LandmarX™ reference arc (REF # 960-632). The FrameLock™ mounts using a titanium screw entering a pilot hole drilled with stainless steel manual drill and accessories. A small percutaneous incision is adequate to install the device. The FrameLock also permits navigation using the sterile drape technique.

The drill is intended to be used with an external drainage and monitoring system in selected patients to reduce intracranial pressure (ICP), to monitor CSF, to provide temporary drainage of CSF, and to monitor ICP. The drill is intended for single use only.

Clinical Neuro Systems Interchangeable Bit Cranial Drill consists of various bit sizes used during a ventriculostomy procedure. The product includes a hand drill with variable chuck, a 0.156" (3.97mm) drill bit with depth guard, a 0.209" (5.31mm) drill bit with depth guard, and a 0.25" (6.35mm) drill bit with depth guard. The depth quard allows accurate, secure, and easy to use adjustment of cranial drill depth. Cranial drill depth is selected by setting the depth guard to the required distance. The Cranial Drill allows for access to the subarachnoid space or the lateral ventricles of the brain. The Cranial Drill is supplied sterile, double CSR wrapped in a Chevron pouch.