(77 days)
The indications for use of the total hip replacement prosthesis include: noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; rheumatoid arthritis; correction of functional deformity; revision procedures where other treatments or devices have failed; and treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement, which is unmanageable using other techniques. This stem is to be press-fit.
The Linear stems without HA coating were cleared for commercial distribution on K974294 and K991325; the Foundation stem on K973302 and K991226; and the The only difference between the devices cleared in the Revelation on K973685. aforementioned submissions and this is the addition of hydroxyapatite to the porous The porous coating is plasma sprayed with coated regions of the proximal bodies. hydroxyapatite (HA).
I am sorry, but the provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria for HA Coated Hip Stems. The document is a 510(k) summary and FDA letter, which primarily focuses on establishing substantial equivalence to predicate devices for regulatory clearance, rather than detailing performance studies and specific acceptance criteria.
The information provided only discusses:
- The submitter's name and address
- Device name, common name, and classification name
- Legally marketed predicate devices
- Subject device description and intended use
- Technological characteristics and basis for substantial equivalence to predicate devices.
- The FDA's decision to clear the device for market based on substantial equivalence.
Therefore, I cannot extract the requested information regarding acceptance criteria or a study proving the device meets those criteria from the provided text.
§ 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.