(141 days)
The Indications for the Furloug® H-AC Total Hip Replacement System are:
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
- Rheumatoid arthritis .
- Correction off functional deformity .
- Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
- Revision procedures where other treatments or devices have failed. .
Not Found
There is no information in the provided document about the acceptance criteria, device performance, or any studies conducted on the Furlong® H-AC Total Hip Replacement System. The document is an FDA 510(k) clearance letter, which indicates that the device has been found substantially equivalent to a predicate device and can be marketed. It lists the indications for use but does not contain details about specific performance metrics or studies.
§ 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.