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Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Total hip replacement is indicated in the following conditions:

• Severely painful and/or disabled joint from 1. osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
• 2. Avascular necrosis of the femoral head.
• 3. Acute traumatic facture of the femoral head or neck.
• 4. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
• Certain cases of ankylosis.
  The Porocoat® Prodigy™ Hip Stem is indicated for cementless use and fixation by biological tissue ingrowth into the porous coating as well as cemented use and fixation in which the porous coating serves as a means to augment the fixation of the prostheses to the bone cement.

The hip stem is manufactured from ASTM F-75 Cobalt-Chromium-Molybdenum alloy and has a sintered cobalt-chrome-molybdenum alloy bead porous coating (Porocoat®) applied to the stem. The porous coating is applied to the entire stem with the exception of the tapered stem tip region of all stems and a modified geometric cut-out area on the medial aspect of the mid portion of the stem of larger-sized prostheses. The stem is designed to be used with AML reamers and broaches and now has been modified to be used with the Excel®/AML impactor. The design utilizes an anteverted neck with a taper for attachment of femoral ball heads. Cobalt-chromium-molybdenum alloy and aluminum ceramic femoral ball heads are intended to be used with the Prodigy Hip prosthesis to provide the femoral prosthetic articular surface for the total hip arthroplasty in combination with a porous coated metal backed acetabular cup prosthesis that uses an ultra high molecular weight polyethylene bearing (UHMWPe) surface.

This document is a 510(k) Summary for a medical device called the Porocoat® Prodigy™ Hip Prosthesis. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving a device meets specific acceptance criteria through a comprehensive clinical study with performance metrics. Therefore, many of the requested categories related to acceptance criteria and detailed study design are not present in this document.

Here's an breakdown of the available information:

1. Table of acceptance criteria and the reported device performance:

This document does not present a table of acceptance criteria and reported device performance. The submission relies on demonstrating substantial equivalence to previously cleared devices rather than meeting new, explicit performance criteria.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not applicable. This is a 510(k) submission for substantial equivalence, not a clinical study with a test set. There are no performance data from a "test set" presented in this document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable. There is no test set or ground truth established by experts in this type of submission for this device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. No test set presented.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is a hip prosthesis, not an AI-assisted diagnostic or imaging device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is a hip prosthesis, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

Not applicable. There is no ground truth presented as part of a performance study in this document. The "truth" in this context is the predicate device's established safety and effectiveness.

8. The sample size for the training set:

Not applicable. No training set is mentioned as this is not a machine learning device or study.

9. How the ground truth for the training set was established:

Not applicable. No training set mentioned.

Summary of the document based on the provided text:

This 510(k) submission (K000207) by DePuy Orthopaedics, Inc. is for the Porocoat® Prodigy™ Hip Prosthesis. The primary aim of this submission is to demonstrate substantial equivalence to existing, legally marketed predicate devices, specifically the Porocoat® Prodigy™ Hip Prosthesis (K931641) and the Vision AML® Hip Prosthesis (K953694).

The device is a total hip joint replacement prosthesis with a porous coating, intended to increase patient mobility and reduce pain by replacing damaged hip joint articulation.

The argument for substantial equivalence is based on:

• The fundamental scientific technologies of the Prodigy Hip Prosthesis having not changed from the cleared Prodigy Hip Prosthesis system (K931641) and Vision AML Hip System (K953694).
• The intended use and indications for use remaining unchanged.
• The device being manufactured from the same material (ASTM F-75 Cobalt Chromium Molybdenum alloy).
• Minor design modifications being the only difference from the predicate device (K931641).
• Conformance with design control procedures (21 CFR 820.30), similarities of design, commonly used materials, and identical sterilization processes.

The FDA reviewed the submission and determined that the device is substantially equivalent to devices marketed prior to May 28, 1976, or reclassified devices. This allows the device to be marketed.

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