(81 days)
Not Found
No
The summary describes a physical implant and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is described as an implant used for the treatment of degenerative arthritis and other clinical conditions in the foot, which are therapeutic medical purposes.
No
The device, MetaSurg cannulated titanium hemi implant, is an implant used for treatment (anatomical replacement), not for diagnosing conditions. Its intended use describes treating degenerative arthritis and other clinical conditions, not identifying them.
No
The device description clearly states it is a "cannulated titanium hemi implant," which is a physical hardware device.
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 MetaSurg cannulated titanium hemi implant is a physical implant designed to be surgically placed within the body to replace a joint. It is a surgical implant, not a device that analyzes biological samples.
- Intended Use: The intended use is to treat degenerative arthritis and other conditions in the foot by replacing a joint component. This is a therapeutic intervention, not a diagnostic test.
The provided information clearly describes a surgical implant used for treatment, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The MetaSurg cannulated titanium hemi implant is indicated for use in the treatment of degenerative arthritis in the 1st metatarsal joint along with the following clinical conditions: Hallux Limitus or Hallux Rigidus, Hallux Valgus and pain or instability in the metatarsophalangeal joint.
The MetaSurg cannulated titanium hemi implant is intended for press fit, uncemented use.
The MetaSurg cannulated titanium hemi implant is intended for single use only.
Product codes (comma separated list FDA assigned to the subject device)
KWD
Device Description
The MetaSurg cannulated titanium hemi implant is designed to be an anatomical replacement for the base of the phalanax. The implant is offered in 5 sizes ranging from 15 - 23mm in diameter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
1st metatarsal joint; metatarsophalangeal joint
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
11. K083469
510(k) Summarv
Date Prepared:
Sponsor:
Company Contact:
Device Trade Name:
Classification Name:
Common Name:
Substantial Equivalence:
Device Description:
Intended Usage:
Material:
November 21, 2008
FEB 1 3 2009
MetaSurg 16350 Park Ten Place, Suite 101 Houston, TX 77084
Mark Myers Phone: (281) 398-5656 Fax: (281) 398-5660
MetaSurg Cannulated Titanium Hemi Implant
Toe joint phalangeal (hemi-toe) polymer prosthesis (21 CFR 888.3730, Product Code KWD, Class II)
Hemi Toe Implant
Documentation is provided to demonstrate the MetaSurg hemi implant to be substantially equivalent to the Vilex hemi implant (K023684) and the BioPro hemi implant (K041595). The methods used to establish equivalence are indications for use, material of construction, sizes, shape and implant type.
The MetaSurg cannulated titanium hemi implant is designed to be an anatomical replacement for the base of the phalanax. The implant is offered in 5 sizes ranging from 15 - 23mm in diameter.
The MetaSurg cannulated titanium hemi implant is indicated for use in the treatment of degenerative arthritis in the 1st metatarsal joint along with the following clinical conditions: Hallux Limitus or Hallux Rigidus, Hallux Valgus and pain or instability in the metatarsophalangeal joint.
The MetaSurg cannulated titanium implant is intended for press fit, uncemented use.
The MetaSurg cannulated titanium hemi implant is intended for single use only.
Titanium Alloy (Ti-6AL-4V ELI)
Section 5 - Page 1 of 1
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with its wings spread, symbolizing strength and protection. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 3 2009
MetaSurg % Mr. Mark Myers 16350 Park Ten Place. Suite 101 Houston, TX 77084
Re: K083469
Trade/Device Name: MetaSurg Cannulated Titanium Hemi Implant Regulation Number: 21 CFR 888.3730 Regulation Name: Toe joint phalangeal (hemi-toe) polymer prosthesis Regulatory Class: II . . . . . Product Code: KWD Dated: February 2, 2009 Received: February 3, 2009
Dear Mr. Myers:
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 such 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); 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.
2
Page 2 -- Mr. Mark Myers
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
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 (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Mark H. Mulkerson
Mark N. Melkerson Director Division of Surgical. Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number: K083469
Device Name: MetaSurg Cannulated Titanium Hemi Implant
Indications for Use:
The MetaSurg cannulated titanium hemi implant is indicated for use in the treatment of degenerative arthritis in the 1st metatarsal joint along with the following clinical conditions: Hallux Limitus or Hallux Rigidus, Hallux Valgus and pain or instability in the metatarsophalangeal joint.
The MetaSurg cannulated titanium hemi implant is intended for press fit, uncemented use.
The MetaSurg cannulated titanium hemi implant is intended for single use only.
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
K08346
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Millberg
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
Si0(k) Number