(64 days)
Intended for use in the acetabulum where severe degeneration, trauma, or other pathology of the hip joint indicates cemented, cementless, or hybrid total hip arthroplasty.
Implex HEP Acetabular Revision Cups, Cemented or Cementless, are available in OD sizes from 40 mm to 72 mm (in 2 mm increments), and with 4 possible ID size options (22 mm, 26 mm, 28 mm, and 32 mm). Implex HEP Revision Acetabular Cups are to be implanted using the Implex Acetabular Cup Instrumentation System.
This document is a 510(k) summary for the Implex HEP Acetabular Cup Revision System. It describes a medical device clearance process by the FDA, not a study performing device performance evaluation against acceptance criteria. Therefore, the information requested by the user is not found in the input document.
The provided document is a 510(k) premarket notification for a medical device and does not contain information on acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert-based evaluations as typically detailed in a clinical or performance study report.
The 510(k) process is primarily a demonstration of "substantial equivalence" to a predicate device, not a comprehensive efficacy or performance study against specific acceptance criteria in the way a clinical trial or a detailed device verification and validation report would.
Therefore, I cannot provide the requested information 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.