(78 days)
This device is indicated for:
- Moderate to severe knee instability
- Significant bone loss and/or ligament deficiencies caused by neoplasms, trauma, rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, and/or avascular necrosis of the proximal and/or distal femur and/or proximal tibia
- Valgus, varus or flexion deformities
- The salvage of previously failed surgical attempts
· A total femoral replacement construct consisting of MOST Options or Segmental proximal femoral, Segmental System segments and Segmental System distal femoral components may be used without cement.
· Variable Stiffness stem extensions require the use of either a smooth or Trabecular Metal stem collar, which must be cemented to the stem. Following cementing to the stem, the smooth collar must be cemented against the bone. The remainder of the stem must be used uncemented.
· Fluted stem extensions require the use of either a smooth or Trabecular Metal stem collar, which must be cemented to the stem. Following cementing to the stem extension, the smooth collar must be cemented against the bone. The remainder of the stem must also be cemented against the bone.
• The Trabecular Metal collar may be used cemented or uncemented against the bone.
• All other constructs are for cemented use only.
The Zimmer Segmental System Proximal Femoral Component is an implantable device, designed to replace the proximal portion of the natural femur. It is manufactured from Tivanium Ti-6Al-4V alloy. The subject device contains suture holes located on the medial and lateral sides for soft tissue attachment, a proximal male taper permitting use with various femoral head components, and a distal female taper that allows for attachment with compatible Zimmer Segmental System components.
The subject modifications are changes to the manufacturing process for the Zimmer Segmental System Proximal Femoral Component.
The provided text is a 510(k) summary for the Zimmer Segmental System Proximal Femoral Component. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.
The 510(k) summary states:
- "Clinical data was not deemed necessary for the o subject device."
- "Non-Clinical Tests: Cleaning validation, including analysis of o bacterial endotoxin, organic contaminants, inorganic contaminants and cytoxicity."
This indicates that the submission primarily focused on demonstrating substantial equivalence through non-clinical tests related to cleaning validation and manufacturing process changes, rather than a performance study measuring specific clinical outcomes or device functionality against defined acceptance criteria.
Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, or clinical study details from this document. The device's approval appears to be based on its similarity to existing, legally marketed predicate devices, with the changes primarily being to the manufacturing process.
§ 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.