Search Results

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. Press-fit components without hydroxyapatite (HA) coating may also be used with bone cement at the discretion of the surgeon.
Femoral heads and endoprostheses are intended for use in cemented and press-fit applications.

The proposed Novation CFS Press-Fit and Cemented Femoral Stems are modifications to the existing Novation Press-Fit and Novation Cemented Plus femoral stem devices previously cleared in K042842 and K083392, respectively. The proposed Novation CFS Press-Fit stem has the same general design features as the predicate device. The modifications include the addition of a calcar collar, grit-blast body, and a satin finish neck. The proposed CFS Cemented stem has the same general design features as the Novation Cemented Plus stem, but the proposed stems are cast instead of forged cobalt chrome alloy and the neck is a satin finish. Both proposed stems contain a modified 12/14 femoral head taper connection.
The proposed stems mate with previously cleared 12/14 Co-28Cr-6Mo femoral heads (K041906), Zirconia ceramic femoral heads (K050398 and K060107) and 12/14 Unipolar Sleeves (K010081). The proposed stems are not compatible with alumina ceramic femoral heads (K032964 and K051682).
The predicate and proposed devices have the same intended use and basic fundamental scientific technology and share the following similarities:
· the same indications for use
· similar design features
· incorporate the same materials
· the same shelf life
· are packaged and sterilized using the same materials and processes.

Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on what is not present as this document is a 510(k) summary for a medical device (femoral stems) and not a study on an AI/ML device:

Important Note: The provided document is a 510(k) Summary for a physical medical device (femoral stems), not an AI/ML device. Therefore, the questions regarding AI/ML performance, sample sizes for training/test sets, expert ground truth, MRMC studies, and standalone algorithm performance are not applicable to this document. The "study" mentioned refers to engineering studies to demonstrate substantial equivalence, not clinical or AI/ML performance studies.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Not Applicable. This document describes a physical medical device. The "test set" in the context of this 510(k) refers to the modified femoral stems themselves undergoing engineering studies (e.g., mechanical testing), not a dataset for an AI/ML algorithm. There is no mention of data provenance (e.g., country of origin, retrospective/prospective clinical data) in the context of an AI/ML test set.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Not Applicable. Ground truth, in the context of AI/ML, involves expert labeling of data. This document pertains to physical device design and engineering validation, not AI/ML.

4. Adjudication Method for the Test Set

• Not Applicable. This refers to AI/ML ground truth establishment.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• Not Applicable. This is specific to AI/ML devices assessing reader performance. The document describes a physical medical device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Not Applicable. This is specific to AI/ML devices. The document describes a physical medical device.

7. The Type of Ground Truth Used

• Not Applicable. For a physical device like a femoral stem, the "ground truth" relates to material properties, mechanical integrity, and biological compatibility, which are assessed through engineering analyses, material testing, and preclinical/clinical data if required (though for a 510(k), often relies on equivalence to predicates) rather than expert consensus on data labels, pathology, or outcomes data in the AI/ML sense.

8. The Sample Size for the Training Set

• Not Applicable. This implies an AI/ML algorithm. The document concerns a physical device.

9. How the Ground Truth for the Training Set Was Established

• Not Applicable. This implies an AI/ML algorithm. The document concerns a physical device.

Summary of Device and Evidence Presented in Document:

The document is a 510(k) summary for new Exactech® Novation® CFS™ Press-Fit and Cemented Femoral Stems. The "study" mentioned refers to engineering studies comparing these modified stems to previously cleared predicate devices (Novation® 12/14 Press-Fit Femoral Stems K042842 and Novation® Cemented Plus Femoral Stems K083392).

The primary acceptance criterion is substantial equivalence to the predicate devices. The device meets this by demonstrating, through engineering studies, that it has:

• The same intended use
• Basic fundamental scientific technology
• Same indications for use
• Similar design features (with specified modifications like calcar collar, grit-blast body, satin finish neck, and cast vs. forged material for cemented stems)
• Incorporates the same materials (except for the casting change)
• The same shelf life
• Packaged and sterilized using the same materials and processes.

The FDA reviewed the submission and concurred that the device is substantially equivalent to legally marketed predicate devices. The specific details of the "engineering studies" (e.g., number of tests, specific parameters measured, statistical analysis) are not provided in this public summary but would have been part of the full 510(k) submission.

Ask a specific question about this device