(101 days)
Total hip components are indicated for uncemented use in individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma, inflammatory joint disease such as rheumatoid arthritis, or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses such as osteoarthritis; avascular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis; diastrophic variant; old, remote osteomyelitits with an extended drainage-free period; nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity. Smith & Nephew MDF Revision Hip System components are intended for single use only and are to be implanted without bone cement.
The Smith & Nephew MDF Revision Hip System is comprised of a stem, modular neck, and modular sleeve component. The components of the revision hip system modularly connect together to form the complete MDF Revision Hip System construct. The MDF hip stem is a straight, tapered, distally fixed, modular stem designed to match the geometry of the femur. The stems are proportionally sized and shaped in sizes 11 through 25 and have modular neck and sleeve options to address patient anatomy. The stems and sleeves are manufactured from titanium alloy (Ti-6Al-AV) and the necks are manufactured from cobalt chrome. Each modular sleeve is coated with Smith & Nephew's Stiktite porous coating. A hydroxylapatite (HA) coating will be applied to the porous coated areas of the MDF modular sleeve by a plasma spray technique.
This is a 510(k) premarket notification for a medical device (MDF Revision Hip System). The provided documents are an FDA clearance letter and the manufacturer's summary of safety and effectiveness, which primarily focuses on establishing substantial equivalence to existing predicate devices.
Consequently, the documents do not contain information related to acceptance criteria, specific device performance studies with sample sizes, expert involvement, ground truth establishment, or comparative effectiveness studies (MRMC or standalone) as typically found in clinical trial reports or performance validation studies for AI/software devices.
The 510(k) process for this type of device relies on demonstrating that the new device is as safe and effective as a legally marketed device (predicate device) and does not generally require new clinical studies to prove performance against pre-defined acceptance criteria in the same way an AI/software device would. Instead, it relies on design, material, and functional equivalence to a known safe and effective predicate.
Therefore, I cannot fulfill the request for information regarding acceptance criteria and performance studies because the provided text does not contain this information. The document focuses on regulatory clearance through substantial equivalence.
§ 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.