(68 days)
The M²a™/C²a™ Acetabular System is intended for cemented or non-cemented use in cases of:
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
- Rheumatoid arthritis
- Correction of functional deformity
- Revision procedures where other treatment or devices have been unsuccessful
- Treatment of non-union, femoral neck fracture, trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques
The M²a™/C²a™ Acetabular System consists of a titanium outer acetabular shell with a cobalt alloy metallic liner for metal articulation.
The acetabular shells are hemispherical in shape to closely match the natural acetabulum. Two screw holes in the dome allow for additional fixation by the use of screws. The outer surface of the shells are covered with Biomet's plasma sprayed coating.
The metallic cobalt alloy bearing liner fits into the outer shell by means of a taper similar to the taper used for the attachment of a modular head to a femoral stem. The metallic liners articulate with cobalt alloy modular heads.
The provided text describes a 510(k) submission for the M²a™/C²a™ Acetabular System, a metallic hip implant. This document is a premarket notification to the FDA for a medical device and therefore does not contain acceptance criteria or a study demonstrating device performance in the context of AI/ML or diagnostic accuracy studies.
The key information from the document related to testing is:
- Non-Clinical Testing: None provided
- Clinical Testing: None provided.
This indicates that the device's substantial equivalence was claimed based on its technological characteristics being similar or identical to legally marketed predicate devices, rather than through new non-clinical or clinical studies. This is a common pathway for 510(k) clearances, especially for devices where the fundamental technology is well-established.
Therefore, I cannot provide the requested information about acceptance criteria or a study proving device performance because this type of information is not present in the provided 510(k) summary. These types of details are more common in PMAs (Premarket Approval applications) or specific studies related to a device's diagnostic accuracy or clinical outcomes, which is not the nature of this document.
§ 888.3320 Hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis.
(a)
Identification. A hip joint metal/metal semi-constrained, with a cemented 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. This generic type of device is limited to those prostheses intended for use with 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 a cemented 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 a cemented acetabular component that was in commercial distribution before May 28, 1976. Any other hip joint metal/metal semi-constrained prosthesis with a cemented acetabular component shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.