(75 days)
- Patient conditions of non-inflammatory degenerative joint disease (NIDJD), e.g., 1. avascular necrosis, osteoarthritis and inflammatory joint disease (IJD), e.g., rheumatoid arthritis.
- Those patients with failed previous surgery where pain, deformity, or dysfunction 2. persists.
- Revision of previously failed arthroplasty. 3.
The APR Porous HA System is intended only for use without bone cement.
The APR Porous HA femoral stem is anatomically designed with right and left components. These stems are available in three proximal body styles to optimize fit of the hip stem in the femoral canal: a standard body, a large body in which the proximal anterior dimension has been widened slightly to maximize filling of the proximal femur, and an oversized for the patient exhibiting the endosteal canal shape (sometimes referred to as Type A) in which the diablysis is disproportionately smaller than the metaphysis. The larger sizes of the stems are stems feature distal hollowing for increased stem flexibility.
The stems are manufactured from wrought Ti-6A1-4V (ASTM F-136). The stems are fabricated with a neck and stem designed to match the natural shape and curve of the femur. Ceramic hydroxylapatite (HA) coated Cancellous-Structured Titanium (CST)) is located on the inferior side of the collar as well as the proximal femoral body. A morse-type taper on the proximal aspect of the stem permits attachment of one of a variety of femoral heads.
This device is intended for use with the following previously cleared devices:
- I IOI metallic femoral bearing heads
- IOI Biolox Bearing Heads
- Zirconia Bearing Heads
- IOI acetabular components
The provided documentation is a 510(k) summary for the APR Porous HA Hip Stem, which is a medical device. This type of regulatory submission in the US focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel clinical safety and effectiveness through extensive studies with specific performance metrics and acceptance criteria. As such, the document does not contain the information requested in points 1-9 regarding acceptance criteria and a study proving the device meets them.
The 510(k) summary focuses on:
- Device Description: What the device is made of, its features, and how it works.
- Intended Use/Indications: The conditions for which the device is meant to be used.
- Substantial Equivalence Claim: The primary argument is that this new device is substantially equivalent to existing, legally marketed devices (the Natural-Hip HA Stem and the APR Universal Hip Stem with Calcitite - Coated CSTi). This is the "proof" required for this type of submission; it's not clinical performance data against pre-defined acceptance criteria.
The FDA's response letter (Section {2}) reinforces this by stating: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent... This decision is based on consideration of the specific design of stem and coating composition detailed in this application." It also explicitly limits the claims the manufacturer can make, stating, "You may not label or in any way promote these devices for enhanced clinical or radiographic performance, enhanced biological fixation and/or long-term stable fixation. The data presented support equivalence with no additional claims over a conventional porous-coated uncemented hip prosthesis (i.e., biological fixation, only)."
Therefore, I cannot extract the requested information from the provided text.
§ 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.