(169 days)
The PRECICE UNYTE CoCr System is indicated for open and closed fracture fixation, pseudoarthrosis, mal-unions and non-unions, or limb lengthening of the tibia.
The PRECICE UNYTE CoCr System is composed of the PRECICE UNYTE CoCr Nail (supplied sterile), locking screws, end cap, surgical instruments and an external remote controller (ERC). The nail is available in tibia models with various diameters and lengths to accommodate a variety of patient anatomies. The locking screws are also available in a variety of diameters, lengths, and configurations (fully and partially threaded). The PRECICE CoC's Nail and end cap are supplied sterile by gamma radiation while the locking screws and surgical 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 supplied either pre-distracted by 10 mm to allow for compression fracture reduction techniques or fully retracted for limb lengthening applications.
This document, K162927, is a 510(k) premarket notification for the PRECICE UNYTE CoCr System, an intramedullary fixation rod for the tibia. The document demonstrates substantial equivalence to a predicate device and does not contain information about the acceptance criteria or a study that proves the device meets specific performance acceptance criteria in the context of an AI/ML device.
The provided text describes a medical device called the "PRECICE UNYTE CoCr System," which is an intramedullary fixation rod for the tibia. The overwhelming majority of the document concerns its regulatory clearance (510(k)) and its substantial equivalence to previously cleared devices. This is a traditional medical device, not an AI/ML device or software as a medical device.
Therefore, the requested information regarding acceptance criteria, device performance, sample sizes for test and training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance, as typically applied to AI/ML devices, is not applicable to this document. The testing performed is related to the physical and material properties, sterilization, and shelf life of the orthopedic implant as outlined in the "Testing of the PRECICE UNYTE CoCr System" section and the table of "Applicable Test Standard" (page 5 and 6).
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.