(223 days)
The MultiFit Total Hip System is intended to be cemented stem or uncemented stem use. The MultiFit Total Hip System is to replace a defective hip joint in the following cases: 1) Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head and nonunion of previous fractures of the femur. 2) Patients with congenital hip dysplasia, protrusion acetabuli, or slipped capital femoral epiphysis 3) Patients suffering from disability due to previous fusion 4) Patients with acute femoral neck fractures.
The MultiFit™ Total Hip System is total hip joint prosthesis which consists of stems, acetabular system, bipolar system and femoral head. Stems are available with two femoral designs. One is manufactured from Ti6A14V alloy which intended for non-cemented use. The other femoral component design is manufactured from CoCrMo and is intended for cemented use. All implant devices are designed for single use only and provided with separated sterilized package. Various sizes are available for each component. Femoral stems - Cementless stem (sizes 130 mm to 150 mm) and cement collared stem (sizes 110 mm to 128 mm) are intended to be used with the other components of the The MultiFit™ Total Hip Metal femoral heads - Metal femoral heads (22 mm and 28 mm in diameter) which is fabricated from Cobalt Chromium Molybdenum (CoCrMo) are intended to be used in conjunction with the commercially available press-fit Ti6Al4V or Co-Cr-Mo alloy Hip Stems cement type and cementless. Acetabular cups and UHMWPE liners - Acetabular cup is manufactured from Ti-6Al-4V ELI and Liner is manufactured from Ultra-High Molecular Weight Polyethylene (UHMWPE). The UHMWPE insert (sizes 22 mm and 28 mm) are intended to be used in conjunction with MultiFit™ Total Hip System acetabular cups (sizes 42 mm to 60 mm in 2 mm increments) in cementless applications. UHMWPE liners are available in two types of Flat and 10° elevated. Bipolar cups and liners - Bipolar cup is made of Cobalt Chromium Molybdenum (CoCrMo) and liner is made of Ultra-High Molecular Weight Polyethylene (UHMWPE) same as acetabular liner. Bipolar cups (sizes 42 mm to 55 mm 1 mm increments) are intended to be used with the bipolar liners (22 mm and 28 mm in diameter) of the MultiFitTM Total Hip System.
The provided text describes a medical device, the "MultiFit™ Total Hip System," a total hip joint prosthesis. It outlines the device's components, indications for use, and a list of bench tests conducted to demonstrate substantial equivalence to predicate devices.
However, the provided document does not describe an AI medical device or a study involving AI technology. Therefore, it is impossible to extract information related to acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or training set details as requested in your prompt.
The document is a 510(k) summary for a physical medical implant (hip prosthesis), focusing on mechanical testing and material equivalence, not AI/software performance.
§ 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.