(23 days)
The MPF Acetabular Cup Generation 2 is intended for uncemented use for all types of arthrosis, such as advanced destruction of the hip joint due to degenerative, post-traumatic or rheumatoid arthritis, fracture or avascular necrosis of the femoral head, sequelae of previous operations, such as internal fixation, joint reconstruction, arthrodesis, hemiarthroplasty or total hip replacement. The same considerations apply to acetabular revisions.
We have added 10 sizes MPF Standard Cup (without screw holes), sizes 46 mm to 64 mm in 2 mm increments and 14 sizes MPF Revision Cup (with 10 screw holes), sizes 46 mm to 72 mm in 2 mm increments. In addition, we have included the following PE inserts: 5 insert for 28 mm ball heads, sizes 39 mm. 41 mm. 44 mm. 48 mm and 52 mm outside diameter. 3 inserts for 32 mm ball heads, sizes 44 mm, 48 mm and 52 mm outside diameter, 5 hooded insert for 28 mm ball heads, sizes 39 mm, 41 mm, 44 mm, 48 mm and 52 mm outside diameter 3 hooded insert for 32 mm ball heads, sizes 44 mm, 48 mm, and 52 mm outside diameter Instead of 7 sizes non-sterile cancellous (spongiosa) bone screws, sizes 20 mm to 50 mm in 5 mm increments for the predicate device, 6 sterile cancellous (spongiosa) bone screws, sizes 25 mm to 50 mm in 5 mm increments are now available with the MPF 2nd generation cup:
I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, sample size, data provenance, expert details, adjudication methods, MRMC studies, standalone performance, or training set specifics. The document is a 510(k) summary for a medical device modification (MPF Acetabular Cup Generation 2), and it primarily focuses on describing the device, its modifications, indications for use, and a declaration of substantial equivalence to a predicate device. It does not contain the kind of detailed study data or performance metrics you are requesting.
§ 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.