(378 days)
The BiMobile Dual Mobility System is indicated for patients with mobility-limiting diseases, fractures or defects of hip joint or proximal femur, which cannot be treated by conservative or osteosynthetic procedures.
The BiMobile Dual Mobility System is indicated for the following conditions:
- · Primary and secondary coxarthrosis
- Rheumatoid arthritis
- · Correction of functional deformities
- · Avascular Necrosis
- · Femoral neck fractures
- · Revision after implant loosening dependent on bone mass and quality
- · Dislocation risks
The device is intended for cemented and cementless use.
The BiMobile instruments are considered a line extension to the instrument system cleared in 510(k) K171273 and K190535 with the BiMobile Dual Mobility System. Like the original instruments, the additional BiMobile instruments are manual orthopedic surgical reusable instruments offered to aid the implantation of the BiMobile Dual Mobility System (K171273 and K190535). The BiMobile Instruments incorporate design changes for simplicity of use. The modifications do not significantly alter the surgical workflow or technique, the intended use, or involve any change in technology.
The provided text is a 510(k) summary for the BiMobile Instruments (for use with Dual Mobility System), an accessory to hip joint prostheses. This document describes the device, its intended use, and argues for its substantial equivalence to previously cleared predicate devices.
This document does not describe a study involving an AI/Machine Learning device or an algorithm-only standalone performance study.
Therefore, I cannot provide the requested information regarding acceptance criteria, reported device performance, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, or training set details, as these are not relevant to the content of the provided 510(k) summary.
The document discusses the substantial equivalence of modified accessory instruments to predicate instruments based on non-clinical testing and evaluations. These evaluations are focused on ensuring the modified instruments function as intended and are safe, not on the performance of a diagnostic or predictive algorithm.
The listed "non-clinical testing and evaluations" are:
- Simulated transport testing
- Biocompatibility assessment
- Interface analysis, functional testing, biolab evaluation, application risk analysis
- Durability testing
- Validation of reprocessing and sterilization instructions
These tests are standard for mechanical medical devices and accessories to ensure their physical integrity, material safety, and functional reliability. They do not involve "device performance" in the sense of accuracy, sensitivity, or specificity as would be relevant for an AI/ML diagnostic.
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.