(90 days)
The ODC™ B2 Bipolar Cup for the Primaloc™ Hip System is intended for single-use cementless implantation during primary or revision arthroplasty surgery. The bipolar cup allows for primary articulation between the acetabulum and femoral stem to restore patient mobility. Indications for use are:
- . Osteoarthritis, theumatoid arthritis, or other osteoarthrosis of the hip joint;
- Certain femoral neck fractures or dislocations; .
- Post-traumatic arthritis; .
- Idiopathic avascular necrosis of the femoral head; ●
- Benign or malignant bone tumors where sufficient bone stock exists to seat the . prosthesis:
- Previously failed surgery ●
The ODC™ B2 Bipolar Cup may be used with the Primaloc™ Cementless Hip System, which is cleared for use under Premarket Notification K953977.
Not Found
The provided document is a 510(k) clearance letter from the FDA for the ODC™ B2 Bipolar Cup. This type of document declares that a medical device is substantially equivalent to a predicate device already on the market. It does not contain information about acceptance criteria, detailed study results, sample sizes, ground truth establishment, or multi-reader multi-case studies.
Therefore, I cannot extract the requested information from the provided text. The document focuses on regulatory approval based on equivalence, not on detailed performance study data.
§ 888.3390 Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis.
(a)
Identification. A hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis is a two-part device intended to be implanted to replace the head and neck of the femur. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a snap-fit acetabular component made of an alloy, such as cobalt-chromium-molybdenum, and ultra-high molecular weight polyethylene. This generic type of device may be fixed to the bone with bone cement (§ 888.3027) or implanted by impaction.(b)
Classification. Class II.