(137 days)
This device is intended to be used for :
- noninflammatory degenerative joint disease including osteoarthritis and 1. avascular necrosis,
-
- rheumatoid arthritis,
- correction of functional deformity, 3.
- revision procedures where other treatments or devices have failed, and 4.
- treatment of non-unions, femoral neck and trochanteric fractures of the proximal 5. femur with head involvement, unmanageable using other techniques.
The implant will consist of a solid, rectangularly cross-sectioned wrought titanium 6AJ- 4V (ASTM 1472) stem with a tapered proximal end intended to seat a conventional cobalt-chrome modular spheric articular interface. The device is intended to articulate with a conventional acetabular implant of the surgeon's choice. Th distal will be a smooth taper A-P and will be step-cut with parallel sides M-L. The proximal stem will be porous coated with commercially pure titanium beads on all surfaces excluding the articular interface trunnion.
The provided text is a 510(k) summary for a medical device, specifically a modular femoral component and head for hip replacement. This document primarily focuses on describing the device, its intended use, and manufacturing materials.
It does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert involvement, or any form of clinical or performance data that would typically be described in the context of device validation or verification studies.
Therefore, I cannot provide the requested information. The document is a regulatory submission summary, not a study report.
§ 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.