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The NeuroPro® Low Profile Cranial Plating System Family is intended for: 1. Internal fixation of fractures and osteotomies of the cranial skeleton. 2. Internal fixation of cranial bone flap osteotomies. 3. Reconstruction of bony defects and deficits in the cranial skeleton. The NeuroPro® Low Profile Cranial Plating System is not indicated for use in the spine or high load bearing applications.

The NeuroPro® Low Profile Cranial Plating System provides rigid fixation of cranial bone flaps with a thin profile for reduced palpability. The system consists of bone screws and mating bone plates and panels with a beveled plate edge and thinner profile to reduce palpability. Malleable bone plates and panels are easily shaped by hand and/or with stainless steel instruments. The bone screws are used to secure various shapes of bone plates and panels to the cranium. The NeuroPro® Low Profile plates and panels are manufactured from Commercially Pure Titanium and meet all of the specifications of ISO 5832-2 or ASTM F-67. The NeuroPro® Low Profile screws are manufactured from 6AV4V ELI (Extra Low Interstitial) Titanium Allov and meet all of the specifications of ISO 5832-3 or ASTM F-136. The NeuroPro® Low Profile Cranial Plating System is a modification of the standard NeuroPro® Cranial Plating System to be made thinner than those in the original submission (K964362), with exception of the hex panels which are the same thickness. The NeuroPro® Low Profile Cranial Plating Screws are a modification of the standard NeuroPro® Quick Tap® Bone Screws to have a shorter screw head height than those in the original submission (K982927). The plates, panels and screws are similar in sizes, dimensions and identical in functionality as the standard NeuroPro® Cranial Plating System which was cleared as part of the original 510(k) submission (K964362). The NeuroPro® Low Profile Cranial Plating System is identical to the standard NeuroPro® Cranial Plating System in terms of intended use, indications for use, material of construction, manufacturing process, functionality, compatibility of the plates and panels with all screw types, shelf life, biocompatibility, packaging and sterilization method.

The SuperCable" Grip and Plate System is indicated for use where wire, cable, or band cerclage is used in combination with a trochanteric grip or bone plate. The SuperCable™ Grip and Plate System is intended to be used in conjunction with the SuperCable™ Iso-Elastic Cerclage System for reattachment of the greater trochanter following osteotomy or fracture, and for fixation of long bone fractures.

The SuperCable" Grip and Plate System consists of trochanteric reattachment grips, cable-plates, and cortical bone screws that are intended to be used in conjunction with 1.5mm diameter SuperCable Iso-Elastic Cerclage polymer cables. The cables pass through the grips and plates and provide fixation by attaching these devices to fractured or osteotomized bone fragments. Cortical bone screws may be used in combination with the cable-plates for additional fixation as deemed necessary by the surgeon user. The system includes a range of cable grip, cable-plate, and bone screw sizes and material options, with associated manual surgical instrumentation. Trochanteric reattachment grips are available in a minimum of four lengths and contain transverse holes for the passage of cables. A cable is passed through the transverse holes and then through its own cable locking clasp, which is part of the cable system. Locking clasps are generally positioned adjacent to the grip on the anterior or posterior surface of the proximal femur. The cable hole exit geometry is designed for optimal cable trajectory and cable contact stress when the grip is affixed to the greater trochanter. Each grip contains two proximal claws that hook into or over the proximal portion of the trochanter fragment and prevent the grip from migrating distally. Each grip also contains two smaller distal claws that penetrate the trochanter fragment distally for additional fixation and stability. The longer grips incorporate an extension to allow for transversely oriented cables around the diaphysis below the lesser trochanter to better resist trochanteric migration or rotation. These longer extensions contain slots for the insertion of compression or locked cortical bone screws into the bone. The grips are available in titanium alloy, cobalt-chromium allov, or stainless steel allov. Cable-plates are available in a minimum of three lengths and contain transverse holes for the passage of cables. A cable is passed through the transverse plate holes and then through its own cable locking clasp, which is part of the cable system. Locking clasps are generally positioned adjacent to the plate. The plates also contain alternating slots for the insertion of compression or locked cortical bone screws into the bone. By combining locking screw holes with compression slots. the plates can be used as both locking devices and fracture compression devices. The plates resemble standard plates, but have figure-of-eight shaped slots that accommodate standard or locking screws. Thus the plate can be used, depending upon the fracture situation, as a compression plate, a locked internal fixator or as a system combining both techniques. The cable hole exit geometry is designed for optimal contact stress within the cable when the plate is affixed to a long bone. The cable-plates are available in titanium alloy, cobalt-chromium alloy, or stainless steel alloy. Bone screws are standard self-tapping cortical bone screws and are available in multiple lengths. The screws heads are available in standard compression or locked designs. The bone screws are available in titanium alloy or stainless steel. The product labeling specifies the screw and plate/grip material combinations which may be used together. Manual instrumentation includes a grip inserter/impactor, drill, depth gage, screwdriver, and sterilization case. All implants are supplied in a non-sterile condition.

The NaviPro"" Shoulder Software Module is a system for computer-aided navigation of surgical instruments whose purpose is to intra-operatively report the orientation of the glenoid and humeral components during shoulder replacement surgery. General spatial measurements may be made and recorded as deemed necessary by the surgeon user.

The NaviPro" Shoulder Software Module is an extension of the previously cleared NaviPro Navigation System. It uses an optical localizing camera and infra-red reflective markers ("trackers") to track the spatial position of bones and medical instruments during shoulder replacement surgery. Measurements obtained from the system allow for intra-operative assessments of implant position and orientation.

The NaviPro™ Knee Software Module is an extension of the NaviPro™ Navigation System whose purpose is to measure the spatial orientation of the resection guides and limb alignment during total knee replacement surgery, and for assessing soft tissue balance and changes in the limb mechanical axis as a result of the knee replacement. General spatial measurements may be made and recorded as deemed necessary by the surgeon user.

The NaviPro™ Knee Software Module is an extension of the previously cleared The Navil Navigation System. It uses an optical localizing camera and infra-red Navil 10 - Navigation 173.60m. 'It ucces an valial position of bones and medical instruments during knee replacements obtained from the system allow for intra-operative assessments of implant position, orientation, and soft-tissue balance.

The Gem™ Inset Patellar Component is intended to articulate with the Gem™ Total Knee femoral component or the KineMatch™ Patello-Femoral Resurfacing Implant. The Gem" Inset Patellar Component is a single use device that is intended for cemented applications on the surgically prepared posterior patella as part of primary or revision knee arthroplasty. The Gem " Inset Patellar Component replaces the patellar articulating surface of the knee joint to simulate the normal function of the knee.

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- Repair of long bone fractures due to trauma or reconstruction; a. - reattachment of the greater trochanter in total hip arthroplasty, surface replacement b. arthroplasty, or other procedures involving trochanteric osteotomy; - c. sternotomy closure; and - d. sublaminar and intrafacet wiring of the spinal column.

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NaviPro™ is a system for computer-aided navigation of surgical instruments whose purpose is to optimally position the acetabular shell during hip replacement surgery, and to report changes in rotational center, limb length, and femoral offset as a result of prosthetic implantation. The system aids the surgeon in accurately positioning the acetabular shell during hip replacement and provides intra-operative measurements of femoral position and orientation in relation to the pelvis. General spatial measurements may be made and recorded as deemed necessary by the surgeon user.

NaviPro™ uses an optical localizing camera and infra-red reflective markers ("trackers") to track the spatial position of bones and medical instruments during hip replacement surgery. Measurements obtained from the system allow for intra-operative assessments of implant position and orientation. NaviPro™ intra-operatively reports the position of the acetabular shell relative to the pelvis as well as the changed relationship between femur and pelvis as a result of joint replacement. The patient data needed to carry out this procedure is recorded intra-operatively. Pre-operative CT or fluoroscopic imaging is unnecessary. The link between patient and computer is established by infra-red reflective trackers that are securely attached to the patient. An infra-red localizing camera that is linked to the computer calculates the position and orientation of the trackers. Surgical instruments, such as an acetabular shell impactor tool and a calibrated measurement probe, are also outfitted with infra-red trackers and can be brought into a spatial relationship with the patient. The NaviPro™ system requires only the information provided by the trackers to determine the orientation of the acetabular shell, as well as changes in limb length and femoral offset.

The KineMatch™ Patello-Femoral Resurfacing Implant is intended to be used in patellofemoral joints with degenerative arthritis of the distal femur and patella, patients with a history of patellar dislocation or patella fracture, or patients with failed previous surgery where patello-femoral joint pain, deformity, or dysfunction persists. The KineMatch™ Patello-Femoral Resurfacing Implant is intended for use with bone cement.

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