(196 days)
Biomet Metal-On-Metal Total hip replacement components are intended for either cemented or uncemented use to replace the articulating portions of the hip during total hip arthroplasty.
Indications For Use:
- Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
- Rheumatoid arthritis.
- Correction of functional deformity.
- (a) Revision procedures where other treatment or devices have failed (M2a-Taper™ and M2a-RinglocTM).
(b) Revision of previously failed total hip arthroplasty (M2a-Magnum™ and M2a-38™). - Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
The components of the M2a-Magnum™ system were also cleared for diastrophic variant, fracture of the pelvis, fused hip, Legg Perthes, slipped capital epiphysis, subcaptial fractures, and traumatic arthritis indications. The M2a-Taper™ Metal-on-Metal Hip Joint Replacement Prosthesis are intended for use in cemented and non-cemented primary and revision hip joint arthroplastic procedures.
Metal-On-Metal Hip prosthesis components provide for total hip replacement with a direct metal to metal articulation. They consist of a series of metal femoral head prostheses (either monolithic or modular) that articulate with highly congruent mating acetabular components without the need for a ceramic or polyethylene liner.
This submission is intended to notify FDA that Biomet has included additional Contraindications to the labeling for Metal-On-Metal total hip prosthesis components to assure the safe and effective use of Biomet Metal-On-Metal components for the appropriate patient populations. These changes are incorporated into one IFU that will be applicable for all Metal-On-Metal components currently cleared by FDA.
The provided text is a 510(k) summary for a medical device. It explicitly states that no non-clinical or clinical testing was performed or included to support substantial equivalence. The submission is solely for updating the labeling (specifically, adding contraindications) for previously cleared metal-on-metal hip prosthesis components.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth, and expert involvement cannot be extracted from this document, as no such studies were conducted for this particular 510(k) submission.
The document indicates:
- "Non-Clinical mechanical testing is not included to support a substantial equivalence determination since this submission is intended only to update labeling for previously cleared medical devices."
- "Clinical testing is not included to support a substantial equivalence determination since this submission is intended only to update labeling for previously cleared medical devices."
As a result, a table of acceptance criteria and reported device performance cannot be generated, nor can any details about studies, sample sizes, experts, or ground truth.
§ 888.3330 Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.
(a)
Identification. A hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis is a two-part 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 consist of a femoral and an acetabular component, both made of alloys, such as cobalt-chromium-molybdenum. The femoral component is intended to be fixed with bone cement. The acetabular component is intended for use without bone cement (§ 888.3027).(b)
Classification. Class III.(c)
Date PMA or notice of completion of PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before May 18, 2016, for any hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976, or that has, on or before May 18, 2016, been found to be substantially equivalent to a hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976. Any other hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.