(19 days)
The Osteonics® Alumina C-Taper Heads are single-use devices and may be used with all appropriately selected, legally marketed Osteonics Ti6A14V alloy femoral stems that incorporate a C-Taper trunnion. Additionally, the Osteonics® 36mm Alumina C-Taper Head is intended for use with any appropriately selected Osteonics® Trident™ Polyethylene Inserts and associated Trident™ Acetabular Shell.
Indications:
- Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
- Revision of previous cup arthroplasty or other procedure.
- Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
- Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies in the acetabulum.
Osteonics® Alumina C-Taper Heads are alumina ceramic femoral bearings that have been designed for assembly, through a taper lock mechanism, to Ti6A14V alloy stems with the Osteonics® C-Taper trunnion design. This line extension to The Osteonics® Alumina C-Taper Heads adds the 36mm diameter size, with neck extensions of +0mm and +5mm. The subject heads are identical in material and design to the predicate heads.
Osteonics® Trident™ Polyethylene Inserts are manufactured from UHMWPE. They are compatible with Trident™ design Acetabular Shells. The subject inserts have an inner diameter of 36mm in order to mate with the subject 36mm alumina head.
I am sorry, but the provided text does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. The document is a 510(k) summary for a medical device (Osteonics® Alumina C-Taper Heads and Osteonics® Trident™ Polyethylene Inserts) and focuses on demonstrating substantial equivalence to predicate devices, rather than presenting performance data against specific acceptance criteria.
Therefore, I cannot provide the requested information.
§ 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.