(47 days)
No
The 510(k) summary describes a mechanical implant for joint replacement and makes no mention of AI, ML, image processing, or any related computational technologies.
Yes
The device is intended for the treatment of degenerative and post-traumatic arthritis, hallux valgus, hallux rigidus, and an unstable or painful metatarsophalangeal (MTP) joint, which indicates a therapeutic purpose.
No
The device is an implantable surgical device used for treatment, not for diagnosing conditions. Its purpose is to replace an articulating surface in a joint.
No
The device description clearly states it is a physical implant made of Cobalt Chromium or Titanium, intended to replace a bone surface. 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 examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description: The Solana Surgical LLC, Metatarsal Decompression Implant is a physical implant designed to be surgically placed within the body to replace a joint surface. It does not analyze biological specimens.
- Intended Use: The intended use is to treat conditions of the metatarsophalangeal joint through surgical implantation, not through the analysis of in vitro samples.
Therefore, based on the provided information, this device clearly falls under the category of a surgical implant, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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 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) or Titanium, intended to replace the articulating surface of the metatarsal bone at the metatarsalphalangeal (MTP) joint. The implant is available in a range of sizes to match the geometry of the metatarsal phalangeal joint. Design features include an articulating surface and a stem which extends proximally in the intramedullary canal of the distal 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
first metatarsophalangeal 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
Not Found
Key Metrics
Not Found
Predicate Device(s)
K09127 Solana Surgical, K070052 Vilex, K023770 Kinetikos Medical, K073065 Osteomed
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
K113752 1/2
5. 510(k) Summary or 510(k) Statement
FEB - 6 20V
Summary of 510 (k) safety and effectiveness information upon which the substantial equivalence determination is based:
| Prepared: | December 16, 2011 |
|---|---|
| Applicant: | Solana Surgical, LLC |
| 6363 Poplar Ave, Suite 434 | |
| Memphis, TN 38119 |
Common Name: Device Trade Name: Device Classification Name:
Device Classification: Reviewing Panel: Regulation Number: Product Code: Predicate Device:
Toe joint, phalangeal (hemi-toe) prosthesis Metatarsal Decompression Implant Toe joint phalangeal (hemi-toe) polymer prosthesis Class II Orthopedic 21 CFR 888.3730 KWD K09127 Solana Surgical, K070052 Vilex K023770 Kinetikos Medical, and K073065 Osteomed
Device Description:
The Solana Surgical Implant is a one-piece device made of Cobalt Chromium (with titanium plasma spray coated stem) or Titanium, intended to replace the articulating surface of the metatarsal bone at the metatarsalphalangeal (MTP) joint. The implant is available in a range of sizes to match the geometry of the metatarsal phalangeal joint. Design features include an articulating surface and a stem which extends proximally in the intramedullary canal of the distal 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.
Indications for Use:
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 or press fit without bone cement.
1
Image /page/1/Picture/0 description: The image shows a handwritten string of characters and numbers. The string starts with the letter 'K', followed by the numbers '113752'. After the number, there is a fraction '2/2' written. The handwriting is clear and legible, with consistent spacing between the characters.
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/1 description: The image shows the address for the Food and Drug Administration. The address is 10903 New Hampshire Avenue, Document Mail Center - WO66-G609, Silver Spring, MD 20993-0002. The address is printed in a simple, sans-serif font.
Solana Surgical, LLC. % Ms. Louise Focht 6363 Poplar Avenue Suite 434 Memphis, Tennessee 38119
FEB - 6 2012
Re: K113752
Trade/Device Name: Solana Surgical 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: December 16, 2011 Received: December 21, 2011
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it your 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 1 touse of action and 1 Dr. Mar 1 Dr. device complies with other requirements of the Act than I Drinas Intacted and regulations administered by other Federal agencies. You must or uny I vatures and the Act's requirements, including, but not limited to: registration and listing (21
3
Page 2 - Ms. Louise Focht
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 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
yours,
For
Melkerson
Peter
N.P
CLIN D.R
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K |13752 Device Name: Metatarsal Decompression Implant Indications for Use:
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 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 Device Evaluation (ODE)
A 1980 (1988) 1998 - 1988) 1998 (1998) 1999 - 1997 (1998) 1987 - 1987 - 1987 - 1987 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999
signature
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number ________________________________________________________________________________________________________________________________________________________________