Search Results

Taper-Fit Total Hip System is indicated for the relief of pain and restoration of hip function following the effects of osteo, rheumatoid and inflammatory arthritis, posttraumatic disease effects, avascular necrosis and total hip revision.

The Taper-Fit Total Hip System is a total hip replacement system comprised of three types of components - femoral stems, modular femoral heads and distal stem centralizers. The femoral stem is manufactured from stainless steel in accordance with BS 7252 Part 9 [ISO 5832-7] - "Wrought Stainless Steel Forgings for Surgical Implants" or High Nitrogen Stainless Steel" and is provided with a distal centralizer. The stem is double tapered, collarless and highly polished. The zirconia ceramic femoral heads are manufactured from high purity 3 mol% Yttria Stabilized Zirconia Polycrystals (Y-TZP). Cobalt-chrome femoral heads are manufactured from cast cobalt-chromium alloy to BS 7252 Part 4 [ISO 5832-4]. All femoral head types, by material, are available in short, standard and long neck sizes. The 12/14 bore on each head is designed to fit a 12/14 stem cone.

The provided text is a 510(k) summary for a medical device (Taper-Fit Total Hip System with ceramic femoral heads). It is not a study report or a publication describing a clinical performance study. Therefore, the information required, such as acceptance criteria, reported device performance, sample sizes, expert qualifications, and ground truth establishment, is not present in the provided document.

This document focuses on establishing substantial equivalence to a previously approved device (the Taper-Fit Hip System with stainless steel femoral heads) for regulatory clearance, rather than presenting a detailed clinical or performance study with specific acceptance criteria and results in the way typically found in a study report.

The document mentions "The results of the testing we claim SE to the predicate device based on seen in Section + of the present scennerries/dimensions, in addition to, similar identical remoral stem and nead goometrics unlained allarines, as demonstrated in the test results." This suggests that some testing was performed to compare the new device to the predicate device, likely focusing on mechanical properties, materials, and geometries to demonstrate equivalence, not on clinical performance or diagnostic accuracy.

Therefore, I cannot populate the requested table or answer the questions based on the provided text.

Ask a specific question about this device

Relief of pain and restoration of hip function following the effects of osteo, theumatoid and inflammatory arthritis, post-trauma disease, avascular necrosis, and total hip revision. These femoral stems are intended for use with bone cement.

The Taper-Fit Total Hip System consists of 4 sizes of stem. For each stem size there are 2 offsets 38 mm & 45 mm. A CDH stem is also available with a 36 mm offset. The modular stem is manufactured from Stainless Steel in accordance with BS 7251 Pt 9 -Specification for High Nitrogen Stainless Steel and is provided with a Polymethylmethacrylate Stem Centralizer. The devices are used to resurface femoral hip joints and reinstate function following the degenerative effects of osteo and theumatoid arthritis, post trauma disease, avascular neurosis and septic/aseptic total hip revision. The stem is double tapered, collarless and highly polished. The stem is used with a 316L Stainless Steel Modular Head. This stainless steel complying to BS 7252 Pt 1: 1997, ISO 5832-1:1997 Metallic Materials for Surgical Implants, Part 1. Specification for Wrought Stainless Steel.

The provided text describes a 510(k) submission for the Corin Taper-Fit Total Hip System, a medical device. However, it does not contain information about acceptance criteria, device performance metrics, or the details of any study conducted to prove the device meets specific criteria.

The document details:

• The device's name and manufacturer.
• A description of the device components (stem, offsets, material).
• The intended use (relief of pain and restoration of hip function due to various conditions like arthritis, trauma, avascular necrosis, and total hip revision).
• The FDA's substantial equivalence determination, allowing the device to be marketed.
• Regulatory classifications and requirements.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance or details about a study to prove acceptance criteria, as this information is not present in the provided text. The document is a regulatory approval letter, not a performance study report.

Ask a specific question about this device