(14 days)
The indications for use for Biomet hip replacement prosthesis include: 1) I no increations for assnerative joint disease including osteoarthritis and avascular necrosis; 2) rheumatoid arthritis; 3) correction of functional deformity; 4) treatment of non-union, femoral neck fracture, and throchanteric fractures of the proximal femur with head involvement, unmanageable using other techniques; 5) revisions of hip replacement components. Standard surgical and rehabilitative procedures are indicted with this device. This device is for use with bone cement
The Color Buffed Answer Cemented Femorals are designed to replace a diseased or damaged femoral neck. A modular head attaches to a trunion to complete the femoral side of a total hip. The stems indicated for cement use and are distally tapered to provide better stress distribution through the cement mantel. A proximal, lateral flare insures proximal canal filling and a closer match to normal anatomy. A medial collar provides initial stability and prevents components subsidence. Each stem is straight, thus eliminating the need for a left and right configurations. The stems utilize a modular head to provide an articulating surface with any commercially available acetabular component. These components are intended for use with bone cement, and as such, have PMMA spacers added to the stem to enhance stability within the cement mantel.
This document is a 510(k) premarket notification for a medical device (Color Buffed Answer Cemented Femorals) and does not contain the acceptance criteria or a study proving the device meets said criteria.
The information provided describes the device, its intended use, potential risks, and the FDA's substantial equivalence determination. It does not include:
- A table of acceptance criteria or reported device performance.
- Details about a test set (sample size, data provenance), experts for ground truth, or adjudication methods.
- Information on a multi-reader multi-case (MRMC) comparative effectiveness study or standalone algorithm performance.
- The type of ground truth used, training set sample size, or how ground truth for training was established.
This is a regulatory approval document, not a scientific study report.
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.