(100 days)
The device is intended for cemented use only in hip arthroplasty applications whose indications include:
- Osteoarthritis, Rheumatoid arthritis, or other Osteoarthrosis 1.
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- Certain femoral neck fractures or dislocation
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- Post traumatic arthritis
- Idiopathic avascular necrosis of the femoral head 4.
- Benign or malignant bone tumors where sufficient bone stock exists to seat the 5. prosthesis
- Previously failed surgery 6.
Legend™ All-poly Cup
I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or any studies related to the Legend™ All-poly Cup. The document is a 510(k) clearance letter from the FDA, which primarily states that the device is substantially equivalent to legally marketed predicate devices and lists its indications for use. It does not include details on how the device's performance was evaluated against specific acceptance criteria.
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented prosthesis is a 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 have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.