(63 days)
The Articul/eze Femoral Heads are intended to be used with DePuy femoral hip stems with Articul/eze (12/14mm) male tapers in cementless total hip arthroplasty for the indications of: a severely painful and/or severely disabled joint resulting from osteoarthritis, traumatic arthritis, or rheumatoid arthritis; avascular necrosis of the femoral head; acute traumatic fracture of the femoral head or neck; a failed previous surgery, including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or other total hip replacement; and certain cases of ankylosis.
The subject Articul/eze Femoral Heads are Co-Cr-Mo alloy femoral heads available in: a 22.225mm diameter with +4 and +7 neck lengths: a 26mm diameter with +4, +7 and +10mm neck lengths and a 36mm diameter with -2, +1.5, +5, +8.5 and +12mm neck lengths. All of the Articul/eze taper femoral heads have an internal 5°43' taper which mates with the 5°40' external taper on DePuy Articul/eze taper femoral stems.
The provided document is a 510(k) premarket notification for a medical device (Articul/eze Femoral Heads) submitted to the FDA in 1998. It primarily focuses on demonstrating substantial equivalence to previously marketed predicate devices, rather than presenting a performance study with acceptance criteria and detailed statistical analysis of a device's performance against those criteria.
Therefore, the information required to fill out the table and answer the specific questions about acceptance criteria and a study demonstrating the device meets those criteria is not present in the provided text. The document states that "DePuy believes that the subject Articul/eze Femoral Heads are substantially equivalent to the above listed predicate devices" based on "similarities of design, material and intended use," but it does not describe a performance study with defined acceptance criteria.
Therefore, an answer in the requested format cannot be generated from the given text.
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.