The Solana Surgical LLC, Hemi Phalangeal Implant System is intended for use as a hemi-arthroplasty implant for the 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 or press fit without bone cement.

Device Description

The Solana Surgical Implant is a one-piece device made of Cobalt Chromium (with titanium plasma spray coated stem) intended to replace the articulating surface of the phalangeal bone at the metatarsalphalangeal (MTP) joint. The implant is available in a range of sizes (3) to match the geometry of the metatarsal phalangeal joint. Design features include an articulating surface and a stem which extends distally in the intramedullary canal of the proximal phalanx. 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

The provided text describes a medical device, the Solana Surgical Hemi Phalangeal Implant System, and its substantial equivalence to predicate devices, but it does not contain any information regarding acceptance criteria, device performance, or a study proving it meets acceptance criteria.

The document is a 510(k) summary and an FDA clearance letter, which focuses on establishing substantial equivalence based on similarities in:

Intended use: Hemi-arthroplasty implant for the metatarsophalangeal joint to treat degenerative and post-traumatic arthritis, hallux valgus, hallux rigidus, and unstable/painful MTP joint.
Device description: One-piece device made of Cobalt Chromium (with titanium plasma spray coated stem).
Materials: Industry standard materials, no new materials.
Design features: Articulating surface and a stem extending distally into the intramedullary canal.
Sizes: Available in a range of 3 sizes.
Usage: Single use, with or without bone cement.

Therefore, I cannot provide the requested table or details about a study demonstrating acceptance criteria, as this information is not present in the provided text. The document is about regulatory clearance for a medical implant, not a performance study of an AI/software device.

Summary

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K120029112/

FEB - 6 2012

5. 510(k) Summary

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

December 30, 2011 Prepared: Solana Surgical, LLC Applicant: 6363 Poplar Ave, Suite 434 Memphis, TN 38119

Toe joint, phalangeal (hemi-toe) prosthesis Common Name: Hemi Phalangeal Implant System Device Trade Name: Toe joint phalangeal (hemi-toe) polymer Device Classification Name: prosthesis Class II Device Classification: Orthopedic Reviewing Panel: 21 CFR 888.3730 Regulation Number: Product Code: KWD K023684 Vilex, Predicate Device: K023770 Kinetikos Medical

Device Description:

Indications for Use:

The device is intended for single use to be used with bone cement or press fit without bone cement.

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Comparison to Predicate Device:

Summary:

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.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Solana Surgical, LLC. % Ms. Louise Focht Vice President Quality and Regulatory 6363 Poplar Avenue, Suite 434 Memphis, Tennessee 38119

FEB - 6 2012

Re: K120029

Trade/Device Name: Hemi Phalangeal Implant System Regulation Number: 21 CFR 888.3730 Regulation Name: Toe joint phalangeal (hemi-toe) polymer prosthesis Regulatory Class: Class II Product Code: KWD Dated: December 30, 2011 Received: January 4, 2012

Dear Ms. Focht:

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

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Page 2 - Ms. Louise Focht

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours,

Mark N. Melkerson

Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K120029 Device Name: Hemi Phalangeal Implant System Indications for Use:

The device is intended for single use to be used with bone cement or press fit without bone cement.

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

Concurrence of CDRH, Office of Devies Evaluation (ODE)

for (Division Sign-Oft)
Division of Surgical, Orthopedic,

and Restorative Devices

510(k) Number

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.