(82 days)
The BRIDGE™ Long Stem Femoral Component is 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 1) necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
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- inflammatory degenerative joint disease such as rheumatoid arthritis;
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- correction of functional deformity;
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- revision procedures where other treatments or devices have failed; and,
- ર) treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
The BRIDGE™ Long Stem Femoral Component consists of two parts, a femoral stem designed with a primary mid-shaft metal seal and a polyethylene seal that provides a secondary seal at the mid-shaft region of the femoral stem. There are 20 sizes (ten right and ten left) for the BRIDGE™ Long Stem Femoral Component. This device is intended for cemented use only.
The provided text is a 510(k) summary for a medical device, specifically the BRIDGE™ Long Stem Femoral Component. It describes the device, its intended use, and indicates that "The BRIDGE® Long Stem Femoral Component demonstrates acceptable fatigue strength." However, the document does not contain any of the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, or comparative effectiveness studies.
The text only mentions "acceptable fatigue strength" as a general statement about testing without providing any specifics on how that was determined or what the criteria for "acceptable" were.
Therefore, I cannot provide the requested information based on the input text.
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.