(84 days)
The Osteonics Alumina C-Taper Heads are single-use devices and may be used with all appropriately selected, legally marketed Osteonics Ti6Al4V femoral stems that incorporate a C-Taper trunnion. Additionally, the Osteonics® Alumina C-Taper Head is intended for use with any appropriately selected, legally marketed Osteonics polyethylene acetabular cup liner and associated metal shell, bipolar or Osteonics all-polyethylene acetabular cup.
For Use as a Bipolar Hip Replacement:
- Femoral head/neck fractures or non-unions.
- Aseptic necrosis of the femoral head.
- Osteo-, rheumatoid, and post traumatic arthritis of the hip with minimal acetabular involvement or distortion.
Other Considerations:
- Pathological conditions or age considerations which indicate a more conservative acetabular procedure and in avoidance of the use of bone cement in the acetabulum.
- Salvage of failed total hip arthroplasty.
For Use as a Total Hip Replacement:
- Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
- Revision of previous cup arthroplasty or other procedure.
- Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
Osteonics" Alumina C-Taper Heads are alumina ceramic femoral bearings that have been designed for assembly, through a taper lock mechanism, to Ti6A14V alloy stems with the Osteonics C-Taper trunnion design. The Osteonics Alumina C-Taper Heads are available in 28mm diameter and 32mm diameter sizes, and in neck extensions of +0mm and +5mm.
The Osteonics" Alumina C-Taper Heads are characterized by the following features:
- A basic spherical design.
- A smooth exterior finish.
- An interior geometry which accommodates any Osteonics stem with a C-Taper trunnion.
These heads differ from the predicate Osteonics C-Taper Zirconia Ceramic Heads in that they feature alumina instead of zirconia ceramic; however both heads incorporate the identical C-Taper bore design. If the titanium adaptor sleeve of the Osteonics" Alumina Ceramic Bearing Head were excluded, the subject head would be identical in design and material to the predicate head.
The provided document does not contain information on acceptance criteria for a device's performance, nor does it describe a study involving performance metrics, sample sizes, expert involvement, or any form of statistical analysis for device validation.
Instead, this document is a 510(k) Premarket Notification Summary for the "Osteonics® Alumina C-Taper Head." It aims to demonstrate substantial equivalence to previously marketed predicate devices, rather than proving a device meets specific performance acceptance criteria through clinical or analytical studies.
The key aspects of this submission focus on:
- Predicate Device Identification: Listing similar devices already on the market.
- Device Description: Detailing the design and materials of the new device.
- Intended Use and Indications: Specifying how the device is meant to be used and for which conditions.
- Statement of Technological Comparison: Comparing the new device to predicates based on intended use, materials, and design, to argue that "None of these design or material differences raise any new questions of safety or effectiveness."
The "supporting testing summary" and "pre-clinical data incorporated by reference to prior submissions" are mentioned in the summary block, suggesting that some foundational testing was done or referenced, but no details of these studies, their methodologies, or acceptance criteria are provided within this document.
Therefore, I cannot provide the requested information. This document is a regulatory submission focused on substantial equivalence, not a performance study report with 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.