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The Distal Volar Radius Anatomical Plate System is intended for the fixation of fractures and osteotomies involving the distal radius.

The modified Distal Volar Radius Anatomical Plate System is a set of orthopedic plates and fasteners supplied in a sterilization tray together with several reusable and disposable tools. The set of orthopedic plates and fasteners provided in the sterilization tray consists of the following implantable devices: • Distal Volar Plates • Distal Dorsal Nail Plate • Pegs • Screws. Included in the sterilization tray are the following re-useable instruments: • Peg drivers • Other standard surgical tools. In addition, the following are non-reusable instruments included in the sterilization tray: • F.A.S.T. Guide Technology Drill Guide; and • Drill bits

The Small Bone Fixation System is indicated for the fixation of extra-articular fractures of the long bones of the hand including the metacarpals and the proximal and middle phalanges, and the metatarsal bones of the foot.

The Small Bone Fixation System is a sterile, single use, disposable device that is delivered non-toxic. The Small Bone Fixation System consists of the Slotted Awl Assembly, the Implantable Nail Handle Assembly, polymer Nail Cap and Exchange Guide and Bend Tube. Prior to use, the implantable nail assembly is nested in the slotted awl assembly. The slotted awl assembly has a trocar point. The implantable nail has a blunt point that is positioned just behind the trocar point of the slotted awl. The sharp point of the slotted awl assembly is passed through a small incision. A hole is drilled into the metacarpal bone by twisting the assembled handles back and forth. After gaining access to the intramedullary space, the slotted awl handle is held stationary while the implantable nail is then advanced distally from the base of the metacarpal bone. The awl handle is then withdrawn and removed for advancement of the implantable nail. The implantable nail is then cut adjacent to the nail handle. Using the bending tube end of the exchange guide and bend tube the implantable nail is bent to 90° with the apex of the bend at the implantable nail insertion site. The nail is trimmed so that the end is below the skin. The small piece remaining will facilitate removal of the implantable nail subsequent to healing. The implantable nail will remain implanted for approximately six weeks. Upon healing of the fracture, the implantable nail is percutaneously removed. In the event that it is desired to reform the implantable nail or implant a smaller nail, this may be accomplished without losing access to the medullary canal. The exchange guide is advanced along the implantable nail into the medullar space. Once the medullar space is accessed, the nail is removed. Another nail may be placed into the medulla by inserting it into the groove of the exchange guide. After the nail has been inserted into the medullar space, remove the exchange guide. An optional locking device may be used to minimize rotation of the implantable nail. The device consists of a pointed stainless steel cannula mounted to a polymeric handle. After the implantable nail is bent to a 90-degree angle, the locking sleeve is positioned over the end of the implantable nail and manually advanced downward through the cortical perforation and into the metaphysis. The locking device is then advanced until tactile feedback confirms ratchet engagement. The locking device may be further advance to the desired depth. When resistance is felt, the locking nail is impacted into its final position with a few sharp taps. The nail and locking sleeve are simultaneously trimmed. The polymer nail cap may be placed over the end of the nail during the healing period.

The Fragment Plate System is intended for essentially non load-bearing stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the hand, foot, wrist, ankle, humerus, scapula, finger, toe, pelvis, and craniomaxillofacial skeleton.

The Fragment Plate System is comprised of a variety of titanium plates with shapes and sizes designed for internal fixation of small bone fragments. The set also includes screws, pins, and k-wires. The screws and pins are have a center drive head and are 2.5 mm in diameter. The plates will include "Y," straight, right, and left configurations. Manual surgical instruments are supplied with the system to facilitate implantation.

The Small Bone Fixation System is indicated for the fixation of extra-articular fractures of the long bones of the hand including the metacarpals and the proximal and middle phalanges.

The Small Bone Fixation System is a sterile, single use, disposable device that is delivered non-toxic. The Small Bone Fixation System consists of the Slotted Awl Assembly, the Implantable Nail Handle Assembly, polymer Nail Cap and Exchange Guide and Bend Tube. Prior to use, the implantable nail assembly is nested in the slotted awl assembly. The slotted awl assembly has a trocar point. The implantable nail has a blunt point that is positioned just behind the trocar point of the slotted awl. The sharp point of the slotted awl assembly is passed through a small incision. A hole is drilled into the metacarpal bone by twisting the assembled handles back and forth. After gaining access to the intramedullary space, the slotted awl handle is held stationary while the implantable nail is then advanced distally from the base of the metacarpal bone. The awl handle is then withdrawn and removed for advancement of the implantable nail. The implantable nail is then cut adjacent to the nail handle. Using the bending tube end of the exchange guide and bend tube the implantable nail is bent to 90° with the apex of the bend at the implantable nail insertion site. The nail is trimmed so that the end is below the skin. The small piece remaining will facilitate removal of the implantable nail subsequent to healing. The implantable nail will remain implanted for approximately six weeks. Upon healing of the fracture, the implantable nail is percutaneously removed. In the event that it is desired to reform the implantable nail or implant a smaller nail, this may be accomplished without loosing access to the medullary canal. The exchange guide is advanced along the implantable nail into the medullar space. Once the medullar space is accessed, the nail is removed. Another nail may be placed into the medulla by inserting it into the groove of the exchange guide. After the nail has been inserted into the medullar space, remove the exchange guide. An optional locking device may be used to minimize rotation of the implantable nail. The device consists of a pointed stainless steel cannula mounted to a polymeric handle. After the implantable nail is bent to a 90-degree angle, the locking sleeve is positioned over the end of the implantable nail and manually advanced downward through the cortical perforation and into the metaphysis. The locking device is then advanced until tactile feedback confirms ratchet engagement. The locking device may be further advance to the desired depth. When resistance is felt, the locking nail is impacted into its final position with a few sharp taps. The nail and locking sleeve are simultaneously trimmed. The polymer nail cap may be placed over the end of the nail during the healing period.

The Distal Radius Fracture Repair System is intended for the fixation of fractures and osteotomies involving the distal radius.

The Distal Radius Fracture Repair System (DRFRS) was previously cleared under 510(k) No. K030198. The system consists of a volar stabilization plate, bone screws, fixation pegs, dorsal intrafocal nail-plate, three fixed angle bone pegs and two locking screws. This 510(k) is being submitted as a modification to the original 510(k) No. K030198 in order to add accessories to the DRFRS. The Distal Volar Radius Plate (DVR) consists of a stabilization plate, bone screws, and fixation pegs. The 3.5 mm screws are used to affix the proximal segment of the plate to the diaphysis. Pegs or screws are used for the distal bone fragment(s). The Distal Dorsal Nail-Plate (DNP) is a bone stabilization device consisting of an intrafocal nail-plate to which three-fixed angle bone pegs and two locking screws are attached. It has a narrow distal plate-like section that lies on the surface of the distal fragment and a proximal nail-like section that is introduced into the diaphysis of the radius through the fracture site. Fixed angle pegs are used to fix the distal fragment(s) to the plate section and locking screws are used to lock the proximal fragment inside the radial shaft. Other components used in the implantation process are identified as the DNP Jig Set of Stainless Steel SST 17-4. These items consist of the DNP Jig drill guide, screw jig and screw guide. A standard awl, which is a manual surgical instrument, used to enlarge t or tunnel by rotary movement is a catalog item manufactured by K-Medic (catalog no. KM-48-336). This submission describes two accessories that are being added to the Distal Radius Fracture Repair Systems, fragment plates and a "K-Type" wire. The fragment plates are essentially smaller implementations of the existing Distal Dorsal Nail-Plates and Distal Volar Radius Plates. The fragment plates are intended for the attachment of small bone fragment plates will be available in the four versions: right, left, straight, and "Y." The fragment plates are made from the same titanium (ASTM F 136 - 96) as the existing Distal Dorsal Nail-Plates and Distal Volar Radius Plates cleared via K030198. The plates are intended to be fastened to bone using the 2.5 mm titanium screws that were cleared via K030198. The K-Wires that will be supplied with the Distal Radius Fracture Repair System are primarily intended for intraoperative use to temporarily locate bone plates or for interfragmental fixation. Even though the K-Wire is intended primarily for intraoperative use, if desired by the surgeon, the K-Wires may permanently implanted. The K-Wires are made from the same titanium (ASTM F 136 - 96) as the existing pins and screws. Three variations of the right and left distal volar plates have been added to accommodate the anatomies of larger and smaller patients. The list of manual surgical instruments included in the Distal Radius Fracture Repair System has been updated.

The Distal Radius Fracture Repair Kit is intended for the fixation of fractures and osteotomies involving the distal radius.

The Distal Radius Fracture Repair System was previously cleared under 510(k) No. K023007. The system consists of a volar stabilization plate, bone screws, fixation pegs, dorsal intrafocal nail-plate, three fixed angle bone pegs and two locking screws. This 510(k) is being submitted as a modification to the original 510(k) No. K023007 to update and standardize the sterilization cycle. The Distal Volar Radius Plate (DVR) consists of a stabilization plate, bone screws, and fixation pegs. The 3.5 mm screws are used to affix the proximal segment of the plate to the diaphysis. Pegs or screws are used for the distal bone fragment(s). The Distal Dorsal Nail-Plate (DNP) is a bone stabilization device consisting of an intrafocal nail-plate to which three-fixed angle bone pegs and two locking screws are attached. It has a narrow distal plate-like section that lies on the surface of the distal fragment and a proximal nail-like section that is introduced into the diaphysis of the radius through the fracture site. Fixed angle pegs are used to fix the distal fragment(s) to the plate section and locking screws are used to lock the proximal fragment inside the radial shaft. Other components used in the implantation process are identified as the DNP Jig Set of Stainless Steel SST 17-4. These items consist of the DNP Jig (left or right), drill guide, screw jig and screw guide. A standard awl, which is a manual tool, used to increase the size of a hole or tunnel by scraping in rotation is a standard catalog item manufactured by from K-Medic under catalog no. KM-48-336. The components of this system will be packaged together and will also be available individually. The materials used for the various components in Distal Radius Fracture Repair System include Titanium TI-6AL-4V ELI and Stainless Steel 440C and SST-17-4. The components within this system will be provided as non-sterile for steam sterilization by health care professionals prior to use. The system is packaged in a high tempered plastic sterilization tray.

The Distal Radius Fracture Repair Kit is intended for the fixation of fractures and osteotomies involving the distal radius.

The Distal Radius Fracture Repair System consists of the Distal Volar Fracture Repair System, which was previously cleared under 510(k) No. K002775. The system comprises volar stabilization plate, bone, screws, and fixation pegs. This 510(k) is being submitted as a modification to the original 510(k) No. K002775 to allow for the dorsal fixation of stable fractures of the distal radius. The Distal Dorsal Nail Plate (DNP) (left and right) is an implantable orthopedic nail-plate device used for the fixation of distal radius fractures. This device permits fixation of distal radius fractures with a minimal incision on the dorsal side while avoiding the tendon adhesion problems. The device consists of a plate portion, which offsets into a nail portion, all cut out of a solid piece of titanium (Titanium TI-6AL-4V ELI anodized Type II). The plate portion is narrow (~6mm) and long (~16mm) and has 3 threaded holes for the attachment of pegs with bending load capacity. These holds are appropriately angled so the pegs fan out and support the distal fracture fragment near the articular surface. The nail portion starts thick and tapers into a long, flexible section. At the start of the taper there are 2 crossing holes spaced about 9 mm apart. The holes are sized to fit 2.5 mm screws, which are used to anchor the nail-plate to the radius proximal of the fracture. The pegs, standard or threaded, and the 2.5mm screws are driven with the Peg Driver. The anchor screws and pegs are available in different lengths to accommodate most patient anatomies and fracture morphologies. Other components used in the implantation process are identified as the DNP Jig Set of Stainless Steel SST 17-4. These items consist of the DNP Jig (left or right), drill guide, screw jig and screw quide. A standard awl, which is a manual tool, used to increase the size of a hole or tunnel by scraping in rotation is a standard catalog item manufactured by from K-Medic under catalog no. KM-48-336. The components of this system will be packaged together and will also be available individually. The materials used for the various components in Distal Dorsal Nail Plate and Jig Set include Titanium TI-6AL-4V ELI and Stainless Steel SST 17-4. The components within this system will be provided as non-sterile for steam sterilization by health care professionals prior to use.

The Intramedullary Fixation System is indicated for the fixation of extra-articular fractures of the long bones of the hand including the metacarpals and the proximal and middle phalanges. The optional locking device may be used to minimize axial and rotational motion of the implantable nail during healing.

The Intramedullary Fixation System for the Hand is a sterile, single use, disposable device that is delivered non-toxic. The Intramedullary Fixation System for the Hand consists of the Slotted Awl Assembly, the Implantable Nail Handle Assembly, and Exchange Guide and Bend Tube. Prior to use the implantable nail assembly is nested in the slotted awl assembly. The slotted awl assembly has a trocar point. The implantable nail has a blunt point that is positioned just behind the trocar point of the slotted awl. The sharp point of the slotted awl assembly is passed through a small incision. A hole is drilled into the metacarpal bone by twisting the assembled handles back and forth. After gaining access to the intramedullary space, the slotted awl handle is held stationary while the implantable nail is then advanced distally from the base of the metacarpal bone. The awl handle is then withdrawn and removed for advancement of the implantable nail. The implantable nail is then cut adjacent to the nail handle. Using the bending tube end of the exchange guide and bend tube the implantable nail is bent to 90° with the apex of the bend at the implantable nail insertion site. The nail is trimmed so that the end is below the skin. The small piece remaining will facilitate removal of the implantable nail subsequent to healing. The implantable nail will remain implanted for approximately six weeks. Upon healing of the fracture, the implantable nail is percutaneously removed. In the event that it is desired to reform the implantable nail or implant a smaller nail, this may be accomplished without loosing access to the medullary canal. The exchange guide is advanced along the implantable nail into the medullar space. Once the medullar space is accessed, the nail is removed. Another nail may be placed into the medulla by inserting it into the groove of the exchange guide. After the nail has been inserted into the medullar space, remove the exchange guide. An optional locking device may be used to minimize rotation of the implantable nail. The device consists of a pointed stainless steel cannula mounted to a polymeric handle. After the implantable nail is bent to a 90-degree angle, the locking sleeve is positioned over the end of the implantable nail and manually advanced downward through the cortical perforation and into the metaphysis. The locking device is then advanced until tactile feedback confirms ratchet engagement. The locking device may be further advance to the desired depth. When resistance is felt, the locking nail is impacted into its final position with a few sharp taps. The nail and locking sleeve are simultaneously trimmed.