(304 days)
The Alpha™ Metasul® Acetabular Insert is intended for use in total hip arthroplasty for treatment of the following:
- patient conditions of noninflammatory degenerative joint disease (NIDD), e.g., rheumatoid arthritis;
- Those patients with failed previous surgery where pain, deformity, or dysfunction persists;
- Revision of previously failed hip arthroplasty.
The Alpha Metasul Acetabular Insert (28mm and 32mm) is a hemispherically shaped design, composed of an outer component manufactured from ultra-high molecular weight polyethylene (UHMWPE) thermo-mechanically bonded to a wrought hot-forged CoCr alloy metallic inlay (in compliance with ISO 5832-12 and ASTM F1537). The Alpha Metasul Acetabular Insert is designed for use only with a Metasul femoral head. The Alpha Metasul Acetabular Insert is a metal-on-metal component, metal surfaces.
The Alpha Metasul 32mm Acetabular Insert, both standard and hooded, is available in sizes 52mm to 68mm (in 2mm increments). In turn, the proposed Alpha Metasul 32mm Acetabular Inserts are designed to mate with Allofit™ Acetabular Shells, sizes 48mm to 68mm (in 2mm increments). Both insert sizes mate the same basic design as the previously cleared Alpha Metasul 28mm Acetabular Insert and share many features with the Ringloc® Acetabular Liner and M2a -Taper Acetabular System.
The Alpha Metasul Insert has what is commonly referred to as a "poly-sandwich" design. The bearing surface of the insert, features a metallic Metasul inlay that is polished to a mirror-finish and themo-mechanically bonded into the proven polyethylene liner, which is then locked into the Allofit acetabular shell via a blocked in snap mechanism. On the hooded inserts, the face of this polyethylene liner incorporates an overhang of polyethylene extending beyond the midpoint of the metallic inlay to help prevent subluxation and instability.
This device is a Class III medical device, however, the provided documentation does not contain a study that proves the device meets specific acceptance criteria.
The document is a 510(k) Premarket Notification for the Alpha Metasul 28mm and 32mm Acetabular Inserts. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not typically for proving efficacy or meeting specific performance acceptance criteria through a clinical study.
The "BASIS OF SUBSTANTIAL EQUIVALENCE" section states: "Performance tests, design comparisons, indications for use and labeling of the Alpha Metasul 28mm and 32mm Acetabular Inserts (Standard and hooded) demonstrations equivalent materials, designs, and indications for use to the predicate devices." This suggests that the submission relied on demonstrating similarity to already approved devices, rather than presenting novel performance data against pre-defined acceptance criteria.
Therefore, I cannot provide the requested information as it is not present in the provided text.
§ 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.