(33 days)
No
The 510(k) summary describes a mechanical implant and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is intended for the treatment of various medical conditions, including degenerative and post-traumatic arthritis, hallux valgus, hallux rigidus, and unstable or painful metatarsophalangeal (MTP) joint, which classifies it as having a therapeutic purpose.
No
The document describes a surgical implant used for hemi-arthroplasty of the metatarsophalangeal joint, a treatment device, not a device used to diagnose a condition.
No
The device description clearly states it is a physical implant made of Cobalt Chromium with a titanium plasma spray coated stem, intended for surgical implantation. This is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body (in vitro).
- Device Description: The Solana Surgical LLC, Hemi Phalangeal Implant System is a physical implant designed to be surgically placed inside the body to replace a joint surface. It is a prosthetic device, not a diagnostic test.
- Intended Use: The intended use is for surgical treatment of joint conditions, not for performing diagnostic tests on patient samples.
Therefore, based on the provided information, this device clearly falls under the category of a surgical implant or prosthetic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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.
Product codes
KWD
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
metatarsalphalangeal (MTP) joint, metatarsophalangeal (MTP) joint
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K023684 Vilex, K023770 Kinetikos Medical
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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:
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.
Indications for Use:
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.
1
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.
2
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
3
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 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.
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