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The Precice Ankle Salvage System is indicated for tibio-talo-calcaneal fusions in adults. When used for tibio-talo-calcaneal fusion, the Precice Ankle Salvage System may be used for open and closed fracture fixation, pseudarthrosis, mal-unions, non-unions, or bone transport of long bones adjacent to the fusion site. The device may be used for subsequent limb lengthening once tibio-talo-calcaneal fusion has been achieved.

The Precice Ankle Salvage System is a tibio-talo-calcaneal fusion system that consists of the Precice Ankle Salvage nail, locking screws, end caps, and associated general instruments. The Precice Ankle Salvage nail is compatible with an accessory External Remote Controller (ERC). The Precice Ankle Salvage nail, endcap, and locking screws are supplied sterile by gamma radiation. The Precice Ankle Salvage nail contains an enclosed rare earth magnet, telescoping distraction rod, and planetary gearing which allows the length of the nail to be adjusted non-invasively by the ERC. Retraction of the Precice Ankle Salvage nail can be utilized to maintain compression across the tibio-talo-calcaneal ioints post-operatively. The Precice Ankle Salvage nail can also be used to subsequentially correct a limb length discrepancy that may result after the tibio-talo-calcaneal fusion procedure. The subject device is manufactured from medical grade Titanium alloy (Ti-6Al-4V) per ASTM F136. The Precice Ankle Salvage nail is available in various nail styles, diameters, and lengths to accommodate a variety of patient anatomies and surgeon preference. The locking screws are available in a variety of diameters, lengths, and thread styles. The ERC is available in several compatible models.

The Precice Intramedullary Limb Lengthening System is indicated for limb lengthening, open and closed fracture fixation, pseudarthrosis, malunions, or bone transport of long bones in patients age 18 years and older and indicated for limb lengthening of the femur and tibia in pediatic patients (greater than 12 years old).

The predicate system is designed to achieve limb correction through gradual lengthening or compression and provide intramedullary fixation for fractures of long bones. The purpose of submission is to add the treatment of pediatric patients (greater than 12 years old) to this the Precice Intramedullary Limb Lengthening System indications for use. The Precice Intramedullary Limb Lengthening System includes the same devices as within the predicate Precice System (K172628) : nail, cortical screws, surgical instruments, and remains compatible with the external remote controllers (ERC) (ERC 1, in K113219; ERC 2P, in K131490; or ERC 3P, in K170169; or ERC 4P, in K191336). The configurations of sets and geometry of previously cleared Precice System devices remain unchanged. The following system description is herein repeated from K172628: Precice Nail is available in various designs, lengths, and screw hole configurations to accommodate a variety of patient anatomies and implantation methods. The screws are also available in a variety of different lengths and thread styles. The ERC is available in several compatible models, including the ERC 1, ERC 2P, ERC 3P and ERC 4P. The subject device components are manufactured from medical grade titanium alloy per ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). The Precice IMLL nail is implanted using locking screws and reusable surgical instruments.

The Precice® System (inclusive of Precice, Precice Bone Transport) is indicated for limb-lengthening, open and closed fracture fixation, pseudarthrosis, mal-unions or bone transport of long bones. The Precice® Plating System is indicated for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions and non-unions of long bones in pediatrics and small stature adult patients. The Precice® Ankle Salvage System is intended for tibio-talo-calcaneal fusions. When used for TTC fusion, the Precice Ankle Salvage System may be used for open and closed fracture fixation, pseudarthrosis, mal-unions, or bone transport of long bones adjacent to the fusion site. The device may be used for subsequent limb lengthening once tibio-talo-calcaneal fusion has been achieved.

The fourth generation External Remote Controller ERC 4P is a portable hand-held system used to non-invasively distract or retract the Precice System Family implants. The ERC 4P device has a touch screen interface, ergonomic design, a single magnet, and implant detection features that provide feedback to the user on the status of the coupling of the implant with the ERC 4P. It can be operated either cordlessly through a rechargeable battery or with a power cord. When the ERC 4P magnet begins to rotate, it induces a magnetic field which rotates an internal magnet attached to a lead screw in the implanted nail/plate, which then either distracts or retracts accordingly. The ERC 4P has a touch screen interface, as well as a hard button for the user's modes of interaction.

The Precice Ankle Salvage System is intended for tibio-talo-calcaneal fusions. When used for TTC fusion, the Precice Ankle Salvage System may be used for open and closed fracture fixation, pseudarthrosis, mal-unions, or bone transport of long bones adjacent to the fusion site. The device may be used for subsequent limb lengthening once tibio-talo-calcaneal fusion has been achieved.

The Precice Ankle Salvage System is a tibio-talo-calcaneal fusion system that consists of the Precice Ankle Salvage Nail, locking screws, end caps, and associated general instruments. The Precice Ankle Salvage Nail is compatible with an external remote controller (ERC). The Precice Ankle Salvage Nail and endcap are supplied sterile by gamma radiation. The locking screws are offered either sterile or non-sterile. The Precice Ankle Salvage Nail contains an enclosed rare earth magnet, telescoping distraction rod, and planetary gearing which allows the length of the nail to be adjusted non-invasively by the ERC. Retraction of the Precice Ankle Salvage Nail can be utilized to maintain compression across the tibio-talo-calcaneal joints post-operatively. The Precice Ankle Salvage Nail can also be used to correct a limb length discrepancy that may result after the TTC fusion procedure. The subject device is manufactured from medical grade Biodur 108 alloy per ASTM F2229. The Precice Ankle Salvage Nail is available in various nail styles, diameters, and lengths to accommodate a variety of patient anatomies and surgeon preference. The locking screws are available in a variety of diameters, lengths, and thread styles. The ERC is available in several compatible models.

The Precice® Bone Transport System is indicated for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, or bone transport of long bones.

The Precice® Bone Transport System includes the Precice® Bone Transport Nail, locking screws, end caps, surgical instruments, and external remote controller (ERC). The Precice ® Bone Transport nails, screws and end caps are supplied sterile by gamma radiation while the instruments are supplied non-sterile and must be sterilized prior to use. The system is designed to achieve limb correction through gradual lengthening or compression of the intercalary bone segment and providing internal fixation for fractures of long bones. The Precice® Bone Transport intramedullary nail is implanted using locking screws, end caps, and reusable surgical instruments. The Precice® Bone Transport nail contains an enclosed rare earth magnet, distraction rod, and planetary gearing which allows the extension of the distraction rod to be adjusted noninvasively by the External Remote Controller (ERC). The Precice ® Bone Transport nail is available in various diameters, lengths and screw hole configurations to accommodate a variety of patient anatomies and implantation methods. The locking screws are also available in a variety of diameters, lengths, and thread styles. The ERC is available in several compatible models.

The MAGEC® System is intended for skeletally immature patients less than 10 years of age with severe progressive spinal deformities (e.g., Cobb andle of 30 dearees or more: thoracic spine height less than 22 cm) associated with or at risk of Thoracic Insufficiency Syndrome (TIS). TIS is defined as the inability of the thorax to support normal respiration or lung growth.

The MAGEC® System is comprised of a sterile single use spinal rod that can be surgically implanted using appropriate NuVasive® Reline®, Reline 4.5-5.0 (Reline Small Stature) or Armada® fixation components (i.e. pedicle screws, hooks and/or connectors). The implanted MAGEC Rod is used to brace the spine during growth to minimize the progression of scoliosis. The system includes a non-sterile hand held External Remote Controller (ERC) 1 or 2 that is used periodically after implantation to non-invasively distract the implanted spinal rod. The titanium MAGEC Rod includes an actuator portion that holds a small internal magnet. The magnet in the actuator can be turned non-invasively by use of the ERC, which is electrically powered. The hand held non-invasive ERC is placed over the patient's spine and then manually activated, which causes the implanted magnet to rotate and either distract or retract the rod. Once the physician determines that the implant has achieved its intended use and is no longer required, the implant is explanted. Additional accessories for the MAGEC® System include the MAGEC Manual Distractor, MAGEC Rod Template, and the MAGEC Wand Magnet Locator. The MAGEC Manual Distractor is a sterile, single use device, which is used in the operating room to test the MAGEC Rod prior to implantation. The MAGEC Rod Template is a sterile, single-use accessory used for intraoperative planning of the surgical procedure. The MAGEC Wand Magnet Locator is a non-sterile device which is used during the distraction procedure to locate the magnet within the MAGEC Rod previously implanted in a patient. The purpose of this premarket notification is to implement assembly process changes and a design change to the MAGEC Rod cleared in K171791 to address the Field Safety Notice and Product Recall issued on February 13, 2020 for the MAGEC X device (FDA Recall Number Z-1898-2020 and Recall Event ID 85495).

The PRECICE® Bone Transport System is indicated for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, or bone transport of long bones.

The PRECICE® Bone Transport System includes the PRECICE® Bone Transport Nail, locking screws, end caps, surgical instruments, and external remote controller (ERC). The PRECICE® Bone Transport nails and end caps are supplied sterile by gamma radiation while the locking screws and instruments are supplied non-sterile and must be sterilized prior to use. The system is designed to achieve limb correction through gradual lengthening or compression of the intercalary bone segment and providing internal fixation for fractures of long bones. The PRECICE® Bone Transport intramedullary nail is implanted using locking screws, end caps, and reusable surgical instruments. The PRECICE® Bone Transport nail contains an enclosed rare earth magnet, distraction rod, and planetary gearing which allows the extension of the distraction rod to be adjusted non-invasively by the External Remote Controller (ERC). The PRECICE® Bone Transport nail is available in various diameters, lengths and screw hole configurations to accommodate a variety of patient anatomies and implantation methods. The locking screws are also available in a variety of diameters, lengths, and thread styles. The ERC is available in several compatible models. The purpose of this submission is to introduce additional compatible locking screws to the system.

The Precice® Screws are provided sterile and intended to be used with the systems below: The Precice® Systemis indicated for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, or bone transport of long bones. The Precice® Stryde System is indicated for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, or bone transport of long bones. The Precice® Bone Transport Systemis indicated for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, or bone transport of long bones. The Precice® Plate System is indicated for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions and non-unions of long bones for pediatrics and small stature adult patients.

The Precice Screws accompanying previously cleared Precice System (K172628) and additional predicates, Precice Stryde System (K180503), Precice Bone Transport (K182170), and Precice Plate System (K192181) are available in a variety of lengths, materials and thread styles. The screws are offered in lengths between 10-100mm and styles including pegs, partially threaded and fully threaded shaft designs. The purpose of this submission is to introduce a sterile option of previously cleared screws as part of the Precice System (K172628) and additional predicates, Precice Stryde System (K180503), Precice Bone Transport (K182170), and Precice Plate System (K192181).

The PRECICE® Plate System is indicated for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions and non-unions of long bones in pediatrics and small stature adult patients.

The PRECICE Plating System includes the PRECICE plate, cortical screws, surgical instruments, and is compatible with an external remote controller (ERC). The PRECICE plate is supplied sterile by gamma radiation while the cortical screws and instruments are supplied non-sterile and must be sterilized prior to use. The system is designed to achieve limb correction through gradual lengthening or compression and providing internal fixation for fractures of long bones. The telescopic PRECICE plate is implanted using cortical screws and reusable surgical instruments. The PRECICE plate contains an enclosed rare earth magnet, telescoping distraction rod, and planetary gearing which allows the length of the plate to be adjusted non-invasively by the External Remote Controller (ERC). The PRECICE Plate is available in various sizes, lengths and screw hole configurations to accommodate a variety of patient anatomies and implantation methods. The cortical screws are also available in a variety of lengths and thread styles. The ERC is available in several compatible models.

The PRECICE® System is indicated for limb-lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions or bone transport of long bones.

The PRECICE® System is composed of the PRECICE® Nail, locking screws, end cap, surgical instruments and an external remote controller (ERC). The Nail is available in various diameters, lengths and screw hole configurations to accommodate a variety of patient anatomies. The locking screws are also available in a variety of diameters and lengths. The PRECICE® Nail and end cap is supplied sterile by gamma radiation while the locking screws and reusable instruments are supplied non sterile and must be sterilized prior to use. The Nail contains an enclosed rare earth magnet, telescoping lead screw/nut assembly, and planetary gearing. The Nail is offered in pre-distracted and non-predistracted models. Pre-distracted models are supplied pre-distracted by 10 mm (femur and, tibia models), 15 mm and 20 mm (humeral model), to allow for compression fracture reduction techniques. The PRECICE® Stryde System includes the PRECICE® Stryde Nail, locking screws, end caps, surgical instruments, and external remote controller (ERC). The PRECICE® Stryde nails and end caps are supplied sterile by gamma radiation while the locking screws and instruments are supplied non-sterile and must be sterilized prior to use. The system is designed to achieve limb correction through gradual lengthening or compression and providing internal fixation for fractures of long bones. The telescopic PRECICE® Stryde Nail is implanted using locking screws, end caps, and reusable surgical instruments. The PRECICE® Stryde Nail contains an enclosed rare earth magnet, telescoping distraction rod, and planetary gearing which allows the length of the nail to be adjusted non-invasively by the External Remote Controller (ERC). The PRECICE® Stryde Nail is available in various diameters, lengths and screw hole configurations to accommodate a variety of patient anatomies and implantation methods. The locking screws are also available in a variety of diameters, lengths, and thread styles. The ERC is available in several compatible models. The reason for this submission is to introduce some design modifications to the third generation of the External Remote Controller (ERC 3P) cleared under K170169. The subject device, ERC 4P, is fourth generation of ERC component of the PRECICE® System.