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.

Device Description

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.

AI/ML Overview

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.

Summary

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K090127 1/2

MAY - 1 2009

510{k} Summary as required by section 807.92(c)

Summary of 510 (k) safety and effectiveness information upon which the substantial equivalence determination is based:

April 8, 2009 Prepared: Applicant: Solana Surgical, LLC 1828 Bailey Drive Oceanside, CA 92056

Common Name: Device Trade Name:

Device Classification Name:

Device Classification:

Reviewing Panel: Regulation Number: Product Code: Predicate Device:

Class II

Orthopedic 888.3730 KWD K070052 Vilex, Met-Head, Resurfacing Hemi-Arthroplasty Implant K031859 Arthrosurface, CAP Great Toe Resurfacing Hemi-Arthroplasty Implant Pending Pending

Toe joint, phalangeal (hemi-toe) prosthesis

Toe joint phalangeal (hemi-toe) polymer prosthesis.

Metatarsal Decompression Implant

Registration Number: Owner Operator Number:

Device Description:

Indications for Use:

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K090127 2/2

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

Comparison to Predicate Device:

Similarities of the Solana Surgical device to its predicates include these devices being: intended for single use only, intended for surgical implantation longer than 30 days, system consisting of a series of implants, made of industry standard materials, with no new materials being introduced in the product, comparably sized, and indicated for the same uses.

Summary:

The Solana Surgical device and the predicate device have the same design characteristics and intended use. The new device is substantially equivalent to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's three goals. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Solana Surgical, LLC % Bruce R. Lawrence, DPM 1828 Bailey Drive Occanside, CA 92056

Re: K090127

Trade/Device Name: Metatarsal Decompression Implant Regulation Number: 21 CFR 888.3730 Regulation Name: Toe joint phalangeal (hemi-toe) polymer prosthesis Regulatory Class: II Product Code: KWD Dated: April 8, 2009 Received: April 10, 2009

Dear Dr. Lawrence:

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, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at

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Page 2 - Bruce R. Lawrence, DPM

(240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Barbara Buehrn

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): _K0901 27 Device Name: Metatarsal Decompression Implant Indications for Use:

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

Prescription Use Over-The-Counter Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Claude Briceno

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number K090127

Page 1 of 1

Regulation Number and Section

§ 888.3730 Toe joint phalangeal (hemi-toe) polymer prosthesis.

(a)
Identification. A toe joint phalangeal (hemi-toe) polymer prosthesis is a device made of silicone elastomer intended to be implanted to replace the base of the proximal phalanx of the toe.(b)
Classification. Class II.