Search Results

The Solana Surgical LLC, Metatarsal Decompression Implant is intended for use as a hemi-arthroplasty implant for the first metatarsophalangeal joint, for the treatment of degenerative and post-traumatic arthritis, hallux valgus, hallux rigidus, and an unstable or painful metatarsophalangeal (MTP) joint.

The device is intended for single use to be used with bone cement.

The Solana Surgical Implant is a one-piece device made of Cobalt Chromium, intended to replace the articulating surface of the first metatarsal at the metatarsalphalangeal (MTP) joint. The implant is available in a range of sizes to match the geometry of the metatarsal head. Design features include an articulating surface and a stem which extends proximally in the intramedullary canal of the metatarsal. The design of the Solana Surgical implant is similar to the predicate devices. No new materials or processes are used in the development of this implant.

This K090127 document is a 510(k) summary for a medical device called the "Metatarsal Decompression Implant" by Solana Surgical, LLC. It is a premarket notification to the FDA to demonstrate substantial equivalence to previously marketed predicate devices.

Based on the provided text, there is no information regarding acceptance criteria or a study that proves the device meets specific performance criteria in the way you've outlined for an AI or diagnostic device. This document is for a physical implant, not a software or AI device.

Therefore, I cannot provide the requested information in the format of a table for acceptance criteria and reported device performance, nor can I answer questions about sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details. These concepts are not applicable to the content of this 510(k) submission.

The document primarily focuses on:

• Device Description: A one-piece Cobalt Chromium implant for the first metatarsal at the MTP joint.
• Indications for Use: Hemi-arthroplasty for degenerative/post-traumatic arthritis, hallux valgus, hallux rigidus, and unstable/painful MTP joint. Single-use with bone cement.
• Comparison to Predicate Device: Emphasizes similarities in intended use, materials, design characteristics, and standard materials used, leading to an assertion of substantial equivalence.
• Regulatory Information: Device classification, product code, and predicate devices.

The FDA's eventual letter confirms substantial equivalence, which is a regulatory determination based on comparing the new device to existing legally marketed devices, rather than a performance study against specific acceptance criteria for a new type of functionality.

Ask a specific question about this device