(279 days)
The Zrconia Ceramic Modular Heads (Norton Advanced Ceramics) are indicated for use in Non-inflammatory Degenerative Joint Disease including osteoarthritis and avascular necrosis, Rheumatoid Arthritis, correction of functional deformity, and revision of failed hip arthroplasty.
This device is a single use implant.
The Biomet ceramic modular head is designed to be the articular surface of an artificial hip joint. The highly polished spherical surface articulates with a polyethylene lined cup. The ball attaches to a metallic femoral stem. These heads are compatible with all of Biomet's hip stems with Type I tapers. This submission covers 28mm diameter heads with various neck offsets.
Biomet Zirconia Ceramic Modular Heads are manufactured from Yttria Stabilized Zirconia. Manufacturing of these ceramic devices will be done entirely outside Biomet by Norton Advanced Ceramics. Zirconia has been shown to possess superior wear qualities in comparison to all metals and even alumina ceramics. Mechanical testing was conducted with the final taper design in accordance with the FDA's guideline document. Devices were found to conform to all requirements including compression, pull-off and fatigue strength.
This document does not contain information about acceptance criteria or a study that proves a device meets such criteria. Instead, it is a premarket notification (510(k)) for a medical device: Zirconia Ceramic Modular Heads.
The provided text includes:
- A summary of safety and effectiveness information for the Zirconia Ceramic Modular Heads.
- A description of the device and its intended use.
- Potential risks associated with the device.
- A list of substantially equivalent devices.
- An FDA letter confirming substantial equivalence and outlining regulatory provisions.
- A form detailing the indications for use of the device.
There is no mention of:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets, data provenance, or the number/qualifications of experts for ground truth.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes.
- Standalone (algorithm-only) performance studies.
- The type of ground truth used (e.g., expert consensus, pathology, outcomes data).
- Sample size for a training set or how ground truth was established for a training set.
This document is focused on the regulatory approval process (510(k) clearance) for a new medical device based on its substantial equivalence to previously marketed devices, rather than a clinical or performance study with defined acceptance criteria.
§ 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.