(22 days)
These devices are modular components of a total hip system. These femoral heads are intended for use with femoral stems and acetabular components in primary or revision total hip arthroplasty.
This Special 510(k) submission is intended to address a design modification to the V40™ and P.C.A.® femoral heads previously manufactured by Howmedica Inc. These femoral heads are available in a range of outer diameter sizes and offsets, and were intended to mate with femoral stems with a 5° 40' taper angle, and 2° 52' taper angle, respectively. These femoral heads were also intended to mate with acefabular components (bipolar and unipolar components, as well as one and two piece acetabular components) manufactured by Howmedica Inc. Since the merger of Howmedica Inc. with Osteonics Corp. (a wholly owned subsidiary of Stryker Corp.), it is desired that these femoral heads should be compatible with acetabular components (bipolar, unipolar, and one and two piece acetabular cups) previously manufactured by Osteonics Corp. In order for this to be accomplished, there must be a design modification made to the femoral heads: a small chamfer must be added to the base of the femoral head to assure that there will not be impingement on the Osteonics bipolar component. It is also desired that femoral heads manufactured by Osteonics be compatible with Howmedica acetabular components. No design change is required to allow Osteonics femoral heads to mate with Howmedica acetabular cups, however, a labeling change will be made to address the compatibility of these components. The modified components, the V40™ and P.C.A.® femoral heads, are substantially equivalent to the predicate devices which were cleared for marketing via the 510k) process. The V40™ and P.C.A.® femoral heads are manufactured from wrought cobalt-chromium-molybdenum (Vitallium®) alloy which conforms to ASTM F-1537.
This document is a 510(k) summary for a design modification to existing femoral heads for hip replacement. It outlines the device, its intended use, and the regulatory classification. However, it does not contain information about acceptance criteria or a study proving device performance against such criteria.
The document describes a design modification (adding a chamfer to the base of the femoral head) to ensure compatibility with another company's acetabular components after a merger. It states that the modified components are "substantially equivalent" to predicate devices, meaning they meet the same performance and safety standards as previously cleared devices. This substantial equivalence is based on the device's material (wrought cobalt-chromium-molybdenum alloy conforming to ASTM F-1537) and its identical intended use to the predicate devices.
Therefore, I cannot provide the requested information from this document. The request specifically asks for a table of acceptance criteria and reported device performance from a study, along with details about sample sizes, ground truth, experts, and adjudication methods. This type of detailed performance data and study design information is not present in this 510(k) summary. This document primarily focuses on regulatory approval based on demonstrating substantial equivalence, not on presenting a detailed performance study against specific acceptance criteria.
§ 888.3360 Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.
(a)
Identification. A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.(b)
Classification. Class II.