(369 days)
The EPF®-PLUS Cementless Press-Fit Acetabular Cup is intended for all types of arthrosis, such as advanced destruction of the hip joint due to degenerative, post-fraumatic or rheumatoid arthritis, fracture or avascular necrosis of the femoral head, sequelae of previous operations, such as internal fixation, joint reconstruction, arthrodesis, hemiarthroplasty or total hip replacement. The same considerations apply to acetabular revisions.
The EPF®-PLUS Cementless Press-Fit Acetabular Cup is a surface treated titanium acetabular cup made from commercially pure titanium. The materials conform to national standards including ASTM F-136-98, ASTM F 67-95, gr. 4, F 639-93, ISO 5832-2. & ISO 5834-1 & -2.
This document is a 510(k) premarket notification for the EPF®-PLUS Cementless Press-Fit Acetabular Cup, submitted to the FDA. It declares substantial equivalence to a previously marketed device, not a new device with performance data. Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth cannot be extracted from this document.
The document focuses on demonstrating that the EPF®-PLUS Cementless Press-Fit Acetabular Cup is "substantially equivalent" to a legally marketed predicate device (PLUS EPF Acetabular Cup, K972931). This means the manufacturer claims the new device has the same intended use, technological characteristics, and safety and effectiveness as the predicate device, or that any differences do not raise new questions of safety and effectiveness.
Key points from the document indicating an equivalence claim rather than a new performance study:
- Section 5. Equivalent Legally Marketed Device(s): Explicitly states the EPF®-PLUS Cementless Press-Fit Acetabular Cup "is substantially equivalent as a result of the use of identical materials, identical indications for use and patient population, identical size offerings, identical instrumentation, identical production facilities and identical sterilization method."
- The only difference mentioned: "The only difference between the original and the modified device is the application of a flame sprayed plasma surface treatment. The characteristics of the surface treatment are not new and are commonly found on many similar orthopaedic implant devices." This statement implies that the new feature (surface treatment) is already well-understood and its performance is not being proven for the first time by this submission.
- FDA's response letter (Page 3): States, "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have found the device substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976..." This confirms the FDA's acceptance based on substantial equivalence, not a de novo performance study.
Therefore, I cannot provide the requested information because this document is not a study report proving the device meets specific acceptance criteria through novel testing. It is a regulatory submission demonstrating equivalence to an already approved device.
§ 888.3360 Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.
(a)
Identification. A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.(b)
Classification. Class II.