(94 days)
The Paragon™ Hip System is intended for use as the femoral component of a total hip replacement or partial hip replacement. This femoral hip stem is intended for uncemented fixation and single use implantation. This prosthesis may be used for the following conditions, as appropriate:
- Degenerative osteoarthritis of the hip.
- Inflammatory arthritis of the hip.
- Secondary arthritis of the hip, such as may follow trauma (e.g. fracture of the femoral neck, or fracture and/or dislocation of the hip or acetabulum), or congenital conditions (e.g. developmental dysplasia of the hip).
- Displaced intracapsular femoral neck fractures where there is a high risk of non-union or avascular necrosis and bone collapse.
- Avascular Necrosis of the femoral head.
- Revision of a failed femoral component from previous hip surgery e.g. internal fixation device from previous osteotomy, fracture treatment or hemi-arthroplasty.
The Paragon™ Hip System is to be used in conjunction with a compatible femoral head and acetabular component as part of a total hip arthroplasty, or as the femoral stem in a hemiarthroplasty. The body of the Paragon™ Hip System tapers proximal to distal in the lateral and frontal planes, and lateral to medial in the sagittal plane resulting in a bi-planar wedge geometry that is conducive to axial and rotational stability. The Paragon™ Hip System is manufactured from titanium alloy (Ti6A14V ELI per ASTM F136) and Hydroxyapatite (HA) (ISO 13779-1 for the HA powder and ISO 13779-2 for the coating).
The provided document does not describe the acceptance criteria or a study that proves the device meets acceptance criteria. Instead, it is a 510(k) summary for the Paragon™ Hip System, which focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through clinical studies.
The document states that "Preclinical Testing" was performed on the Paragon™ Hip System, including "Range of Motion, Stem Fatigue Testing, Neck Fatigue Testing, Burst Strength Testing when coupled with ceramic femoral heads, and characterization of the stem's HA coating." It also states that "The results support the substantial equivalence of the Paragon™ Hip System." However, it does not provide details on the specific acceptance criteria for these tests, nor does it present the detailed results of these tests.
Therefore, I cannot provide the requested information.
§ 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.