(378 days)
All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Components of Exactech Hip Systems are also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion.
- · Cemented femoral stems and cemented acetabular cups are intended for cemented fixation only.
- · Press-fit femoral stems and acetabular cups are intended for press-fit fixation.
- · Femoral heads and endoprostheses are intended for use in cemented and press-fit applications.
The Exactech Alteon Short Tapered Wedge is a collarless, press-fit femoral stem component to be used in total or hemi hip arthroplasty, and is designed to emphasize medial/lateral fixation of the device and axial/rotational stability when implanted in the femoral/medullary canal.
The Alteon Short Tapered Wedge has seventeen size offerings and two lateral offsets per size. It is made from titanium alloy and includes a 12/14 trunnion, a polished neck region, a commercially pure titanium plasma spray coated press-fit region, and a bead-blasted (satin) distal surface finish. The 12/14 trumion allows for compatible connection with Exactech femoral heads. As a line extension to the predicate, the proposed Alteon Short Tapered Wedge differs from the predicate in that it features a shortened distal stem length.
This document is a 510(k) premarket notification for a medical device called the Exactech® Alteon® Short Tapered Wedge femoral stem. It focuses on demonstrating "substantial equivalence" to a predicate device, rather than proving the device meets specific acceptance criteria through a study involving human or AI performance.
Therefore, the requested information about acceptance criteria, study design for device performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone AI performance, and ground truth establishment is not available in this document.
This notice details:
- Device Name: Exactech® Alteon® Short Tapered Wedge
- Purpose: Femoral Stem Hip Prosthesis, used in total or hemi hip arthroplasty.
- Indicated Use: For skeletally mature individuals undergoing primary surgery for hip replacement due to various conditions (osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems, proximal femoral fractures) and potentially for ankylosing spondylitis, congenital hip dysplasia, revision of failed reconstructions, and to restore mobility from previous fusion.
- Substantial Equivalence Claim: The device claims substantial equivalence to the Exactech Alteon Tapered Wedge Femoral Stem (K140674) based on similar indications for use, materials, performance requirements (conforming to recognized standards), manufacturing, sterilization, and design features.
- Non-Clinical Testing: The document lists various non-clinical engineering and mechanical tests performed to demonstrate performance (e.g., Distally Fixed Fatigue testing, Femoral Neck Proximal Fatigue testing, Femoral Head Modular junction burst testing, Coating characterization, Range of Motion analysis, Template Studies, Cadaveric Evaluation), but these are not "studies" in the context of clinical performance or AI/human reader performance as implied by the user's request.
In summary, this document is a regulatory submission for a physical medical device (femoral stem), not a software or AI-driven diagnostic device that would typically involve the requested performance study elements.
§ 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.