(42 days)
Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Total hip replacement is indicated in the following conditions: 1) a severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia: 2) avascular necrosis of the femoral head; 3) acute traumatic fracture of the femoral head or neck, 4) failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement; and 5) certain cases of ankylosis.
Cemented Components:
Femoral stem and acetabular cup total hip components labeled "For cemented use only" are indicated only for use with bone cement.
The subject device is a cobalt chromium molybdenum alloy modular and smooth stemmed prosthesis that is intended for cemented use to replace the femoral portion of the hip joint in total hip arthroplasty.
This document describes a 510(k) premarket notification for a medical device, the Excel Fracture Cemented Hip Stem - Size 1. The document is primarily focused on demonstrating substantial equivalence to a previously cleared device, not on presenting a study with acceptance criteria and device performance metrics.
Therefore, the requested information regarding acceptance criteria, device performance, study sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be extracted from the provided text.
The 510(k) summary (K011367) states that the "[size 1 Excel Fracture Cemented Hip Stem is identical in design, material, manufacturing process and intended use to the Excel Fracture Cemented Hip Stem cleared as Response 2000 Cemented Hip Stem] (K00432), except for being a smaller size." This indicates that the regulatory approval relies on the pre-existing approval of the predicate device, assuming similar safety and effectiveness due to the high degree of similarity and the only difference being a smaller size.
Therefore, the information regarding the acceptance criteria and the study that proves the device meets the acceptance criteria is not present in the provided 510(k) summary. These details would typically be found in the original submission for the predicate device (Response 2000 Cemented Hip Stem, K00432) or in a more comprehensive technical document not included here.
§ 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.