Search Results

Intended Use: The DePuy Peak Fx Hip Plate is intended for internal fixation of hip fractures.

Indications for Use: The Peak Fx Hip Plate is indicated for the following fractures of the proximal femur:

• . Basilar neck fractures
• . Intertrochanteric fractures
• . Subtrochanteric fractures

The Peak Fx Hip Plate is indicated for stable and unstable fractures in which a stable medial buttress can be reconstructed.

The DePuy Peak Fx Hip Plate System is comprised of plates in various lengths with two to twelve holes, barrely assemblies in various lengths with angles from 125° to 140°, a key and key screw, and a limited collapse caro.

This 510(k) submission (K063509) for the DePuy Peak Fx Hip Plate directly states that the substantial equivalence is shown by its similarity in intended use, indications for use, materials, and design to the existing DePuy Captured Hip Screw System (CHS), K813554, cleared on January 12, 1982.

This means the submission is not based on performance testing of the device against specific acceptance criteria. Instead, it relies on the predicate device standard. Therefore, the document does not contain information about:

• A table of acceptance criteria and reported device performance.
• Sample sizes, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance studies, or how ground truth was established for this specific device.

The FDA's letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."

In summary, the information requested in your prompt related to performance studies, acceptance criteria, and ground truth establishment is not present in the provided 510(k) summary as this device was cleared based on substantial equivalence to a predicate device, rather than new clinical performance data.

Ask a specific question about this device