(79 days)
The Hip Stem components are indicated for use in total or partial hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis and non-union of femoral fractures. These devices are indicated for use only with Bone Cement (PMMA).
The P.F.C. Ceramic Hip Head is designed as a modular head, compatible with Johnson & Johnson Professional, Inc.'s femoral stems with a 12/14 Morse-type taper.
All Hip Stem components are manufactured using cobalt-chromium-molybdenum alloy that complies with ASTM F799. The Ceramic Hip Head is manufactured of Yttrium Stabilized Zirconium Oxide (Zirconia), also known as PROZYR®
The provided text describes a medical device (P.F.C. Ceramic Hip Head with specific Hip Stems) and its substantial equivalence to previously cleared devices. It outlines the device classification, indications for use, and physical description. However, the document does not contain information related to acceptance criteria, device performance metrics, or study details (like sample size, ground truth establishment, expert qualifications, or MRMC studies) as requested in the prompt.
The document states: "The test results obtained for the Ceramic Hip Head exceed the requirements of the Guidance Document ("Guidance Document for the Preparation of Premarket Notifications for Ceramic Ball Hip Systems"-Draft, January 10, 1995)." This indicates that some testing was performed and met a standard, but it does not provide the specific acceptance criteria or the reported performance outcomes.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided input.
§ 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.