(59 days)
The Restoration® Modular System is intended for primary or revision total hip arthroplasty, as well as in the presence of severe proximal bone loss. These femoral stems are designed to be press fit into the proximal femur. Examples of specific indications for use of the Restoration® Modular System include: Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis, Rheumatoid arthritis, Correction of functional deformity, Revision procedures where other treatments or devices have failed, and Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
The Restoration® Modular Hip System is a modular hip system comprised of different proximal body styles and three distal stem designs, which are affixed with the use of a locking bolt. These individual components are assembled by the surgeon in the operating room or in situ to allow independent sizing of the proximal body and distal stem to better fit the patient. This submission modifies the existing Restoration® Modular Cone Body to create a new style of proximal body called the Restoration® Modular Calcar Body for use with the previously cleared Restoration® Modular Distal Stem components.
The provided document is a 510(k) Premarket Notification for a line extension to a modular hip system. It describes the device, its intended use, and states that it is substantially equivalent to predicate devices based on similarities in intended use, materials, and design, and confirmed by mechanical testing and analysis.
However, the document does not contain information about acceptance criteria or a study proving that the device meets specific acceptance criteria in the context of algorithm performance or clinical outcomes. The "study" mentioned refers to mechanical testing for demonstrating substantial equivalence of the new components to predicate devices. There is no mention of any AI or software-based device, nor any performance metrics, sample sizes for test/training sets, expert ground truth, or adjudication methods typically associated with studies for such devices.
Therefore, the requested information cannot be extracted from this document in the format provided.
Specifically, none of the requested information points 1 through 9 can be addressed as they pertain to the evaluation of an algorithm or software device, which is not the subject of this 510(k) filing.
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.