(64 days)
The M³a™ Magnum™ System is indicated for use in patients requiring total hip replacement due to the following:
- Non-inflammatory degenerative joint disease including avascular necrosis, diastrophic variant, fracture of the pelvis, fused hip, Legg Perthes, osteoarthritis, slipped capital epiphysis, subcapital fractures and traumatic arthritis.
- Rheumatoid arthritis .
- · Correction of functional deformity
- · Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques
- · Revision of previously failed total hip arthroplasty
The M a ™ Maqnum™ System consists of a CoCrMo monolithic acetabular cup, which articulates with a CoCrMo modular head. The smaller femoral heads, sizes 38mm and 40mm, are a one-piece design with neck length variations ranging from –6mm to +12mm. The larger femoral heads, sizes 42mm to 60mm, are a modular design with neck length variations ranging from -6mm to +9mm, achieved through the use of a titanium adapter assembled with the modular head component at the time of surgery. The femoral heads may be used in conjunction with any of Biomet's commercially available Type I taper femoral component.
I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria. The document is a 510(k) summary for the M2a™ Magnum™ System, detailing its classification, predicate devices, and indications for use. It explicitly states: "Clinical Testing: Clinical testing was not used to establish substantial equivalence to predicate devices." Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, or study details.
§ 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.