(269 days)
The device is used for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:
- Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
- Revision of pervious unsuccessful femoral head replacement, cup arthroplasty or other procedure.
- Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
- Correction of function deformity.
- Treatment of nonunion femoral neck and trochanteric fracture of the proximal femur with head involvement that is unmanageable using other techniques.
The device is intended for cementless use.
This device is an extension in terms of additional size to the previously cleared U-Motion II Acetabular System (K122185) and U-Motion II PS+ Cup (K132455). U-Motion II acetabular component includes U-Motion II Cup and U-Motion II XPE Cup Liner. The indications, materials, design, safety and effectiveness of U-Motion II Cup and Cup Liner are identical to the cleared U-Motion II Acetabular System (K122185) and U-Motion II PS* Cup (K132455) except the dimension. The subject U-Motion II Cups are available in size Ø 50 mm and Ø 46 mm O.D. and the subject U-Motion II Cup Liners are available in 32 mm and 36 mm I.D. The 32 mm and 36 mm inserts fit the acetabular shells with 46 mm O.D. and 50 mm O.D., respectively.
I am sorry, but the provided text does not contain the information required to answer your request. The text describes a 510(k) premarket notification for a medical device (U-Motion II Acetabular System- Additional Sizes), focusing on its substantial equivalence to previously cleared predicate devices.
The document discusses:
- Device name and regulation
- Indications for use
- Device description, including materials and design
- Comparison to predicate devices
However, it does not contain any information regarding acceptance criteria, study methodologies (like sample sizes, data provenance, expert usage, adjudication methods, MRMC studies, standalone performance), or ground truth establishment related to a study proving the device meets acceptance criteria. It only states, "The mechanical properties of this device have been evaluated, and the analysis results shown that this subjected device is not the worst case within all sizes of U-Motion II Acetabular System. These adding sizes would not affect the safety and effectiveness." This sentence indicates that some evaluation was done, but does not provide the specific details requested in your prompt.
§ 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.