(287 days)
This device is intended to be used for :
- noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis,
- rheumatoid arthritis,
- correction of functional deformity,
- revision procedures where other treatments or devices have failed, and
- treatment of non-unions, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
The implant will consist of a solid, rectangularly cross-sectioned wrought titanium 6Al- 4 V (ASTM 1472) stem with a tapered proximal end and is intended to seat a conventional modular spherical head. The device is intended to articulate with a conventional acetabular implant of the surgeon's choice. The distal portion will be a smooth taper anterior-posteriorly and will have step-cut sides medial-laterally. The proximal stem will be porous coated with commercially pure titanium plasma spray on all surfaces excluding the articular interface trunnion.
The provided text is a 510(k) summary for a medical device (Quatroloc Plasma Sprayed Femoral Component) and does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.
A 510(k) submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving device performance against detailed acceptance criteria through a specific study as would be seen in a clinical trial or performance study report.
Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving device performance from the provided document. The document primarily describes the device, its intended use, manufacturer information, and the FDA's decision regarding its clearance based on substantial equivalence.
§ 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.