(78 days)
- Noninflammatory degenerative joint disease (NIDJD), e.g. avascular necrosis, ● osteoarthritis, and inflammatory joint disease (IJD), e.g. rheumatoid arthritis.
- Failed previous surgery where pain, deformity, or dysfunction persists. .
- Revision of previously failed hip arthroplasty. .
The Wagner Cone Prosthesis stem is a straight, collarless stem system designed for uncemented fixation. The surface of the prosthesis is rough blasted, and it has a tapered shape with an angle of five degrees. The stem has eight longitudinal ribs, and it is available in two different CCD angles, 125° and 135°. The stems are available in twelve diameters, ranging from 13 to 24 mm.
This document does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria.
The provided text is a 510(k) premarket notification for the "Wagner Cone Prosthesis® System." It focuses on:
- Summary of Safety and Effectiveness: This section primarily establishes substantial equivalence to predicate devices.
- Device Description: Describes the physical characteristics of the prosthesis.
- Intended Use: Lists the medical conditions the device is designed to treat.
- Comparison to Predicate Device: Highlights similarities with previously cleared devices.
- Performance Data (Nonclinical and/or Clinical): States that non-clinical tests (Stem and Neck Fatigue Testing, Biocompatibility Testing, and Burst Strength Testing of Ceramic Femoral Heads) were completed, but explicitly mentions "Clinical data and conclusions were not needed for this device."
Therefore, I cannot provide the requested information. The document does not discuss a study with a test set, ground truth establishment, expert adjudication, or other metrics typically associated with proving a device meets acceptance criteria derived from clinical or AI performance studies. The scope of this document is limited to demonstrating substantial equivalence for regulatory clearance, not detailed performance metrics against specific acceptance thresholds.
§ 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.