(77 days)
Indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:
- non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
- inflammatory degenerative joint disease such as rheumatoid arthritis;
- correction of functional deformity;
- revision procedures where other treatments or devices have failed; and,
- treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
The PRO-FEMUR R Revision Hip System is a modular prosthesis comprising of four principal parts:
- · Distal stem with cutting flanges for the diaphyseal fixation
- · Extension Adapter
- · Proximal body for support in the metaphyseal region
- " Modular neck
The PRO-FEMUR R distal stem will be available in three different lengths, namely SHORT, MEDIUM, and LONG, in increments of 1mm from 10mm to 22mm in diameter. The SHORT distal stem (135mm) is straight, and the MEDIUM (175mm) and LONG (215mm) are both anatomically curved. All distal stems are slightly conical in profile and feature cutting flanges that provide excellent primary fixation. The cutting flanges are absent on the anterior and posterior curvature of the stem in order to reduce the possibility of femoral fracture during impaction.
The PRO-FEMUR R Proximal Body will be available in seven different sizes: Extra Small, Small, 4x Standard and Large. The four standard components have the same length but became progressively wider.
The distal stem is secured to the proximal body by morse taper and secondly by a fixation screw.
To further lengthen the implant by either 26 or 52 mm, extension adapters are available. They are positioned between the selected proximal body and distal stem and secured by morse taper and a longer fixation screw.
The proximal body has a specific oblong housing for the insertion of the twelve modular necks which are available in six versions and two lengths: Neutral, antiversion/ retroversion 8° or 15°, varus/ valgus 8°, or combination of anteverted/ retroverted - varus/ valgus (in both short and long lengths)
The design features of PRO-FEMUR R Revision Hip System are substantially equivalent to competitive devices previously cleared for market.
I am sorry, but the provided text describes a 510(k) summary for a medical device (PRO-FEMUR R Revision Hip System) and explicitly states that its safety and effectiveness are supported by "substantial equivalence information, materials data, and testing results provided within the Premarket Notification."
However, this document does not contain any acceptance criteria, reported device performance data, information on a specific study proving the device meets acceptance criteria, sample sizes for test or training sets, details about ground truth establishment, or any information regarding AI assistance or human reader studies. It is a regulatory document affirming equivalence to previously marketed devices based on design and materials.
Therefore, I cannot fulfill your request for the described information based on the text provided.
§ 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.