(182 days)
All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Components of Exactech Hip Systems are also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion.
- Cemented femoral stems and cemented acetabular cups are intended for cemented fixation only. ●
- Press-fit femoral stems and acetabular cups are intended for press-fit fixation.
- o Femoral heads and endoprostheses are intended for use in cemented and press-fit applications.
Proposed Exactech Alteon Acetabular Cup System implants are acetabular components intended for use as part of total hip arthroplasty. Alteon Acetabular Cup System implants share key design features, materials, Indications for Use statements, geometry, and compatibility with other Exactech acetabular components marketed under the brand names AcuMatch and Novation.
The Alteon Acetabular Cup System includes metallic acetabular cups that feature an Asymmatrix™ porous coating, intended to make the devices compatible with press-fit total hip arthroplasty. Like predicate AcuMatch and Novation liners, Alteon XLE liners are manufactured from Type 1 ultra-high molecular weight polyethylene (UHMWPE) blended with vitamin E. Both cups and liners are available in a range of sizes and geometries intended to give surgeons options for meeting the needs of a range of patient anatomies.
The proposed devices operate using the same fundamental scientific technology, have the same intended use and design features, employ the same materials of construction, are offered in the same product size scopes, and are implanted using a similar surgical technique and the same or similar instrumentation. The only modifications proposed by this submission are dimensional.
I am sorry, but the provided text is a 510(k) premarket notification for a medical device (Exactech® Alteon® Acetabular Cup System - a hip replacement component). This type of document is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria through a clinical study.
Therefore, the information required in your request, such as a table of acceptance criteria and device performance, sample sizes for test sets (prospective/retrospective), number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth, and training set information, is not present in the provided text.
The document primarily focuses on:
- Device Description: Explaining the components, materials, and design features of the Exactech® Alteon® Acetabular Cup System.
- Indications for Use: Defining the conditions for which the device is intended.
- Substantial Equivalence Claim: Stating that the device is substantially equivalent to previously cleared Exactech devices (AcuMatch® A-Series and Novation® Crown Cup systems).
- Testing Description for Equivalence: Listing mechanical tests and engineering analyses performed (e.g., wear, impingement, disassembly, range of motion, pyrogen testing) to support the claim of substantial equivalence. These are typically bench tests rather than clinical studies with human subjects.
The 510(k) process does not typically require extensive clinical trials with human subjects to prove performance against acceptance criteria in the way a PMA (Premarket Approval) submission would. Instead, it relies on demonstrating that the new device is as safe and effective as a predicate device already on the market, often through non-clinical performance testing and comparison of design, materials, and intended use.
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.