(83 days)
Not Found
No
The device description focuses on the material, design, and mechanical function of a metal implant for joint resurfacing. There is no mention of software, algorithms, image processing, AI, or ML. The predicate devices are also mechanical implants.
No
The device is a non-therapeutic implant designed to fixate or resurface a joint, not to treat or cure a disease or condition.
No
The device description indicates that it is an implant designed for fixation and resurfacing of a joint. Its intended use is for Hallux Limitus or Rigidus, which are conditions that it is meant to treat, not diagnose. There is no mention of diagnostic functionalities such as imaging, signal analysis, or disease detection.
No
The device description clearly states it is a "fixation metal device" and describes its physical characteristics and components, indicating it is a hardware medical device.
Based on the provided information, 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, or tissue) to provide information about a person's health.
- Device Description: The description clearly states this device is a "fixation metal device" designed to be implanted in the body to resurface an arthritic joint. It's a surgical implant, not a device used to test samples outside the body.
- Intended Use: The intended use is for "Hallux Limitus or Rigidus" and "Resurfacing of Arthritic /Metatarsal joint," which are surgical procedures.
- Anatomical Site: The anatomical site is the "Metatarsal/Phalangeal (MTP) Joint," an internal part of the body.
The description of the device and its intended use are consistent with a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Vilex "The Met-head", as designed, has the following Indications for Use:
Hallux Limitus or Rigidus
Halux Valgus
Metatarsal/Phalangeal (MTP) Joint
To fixate, use cement or press fit without cement
Product codes (comma separated list FDA assigned to the subject device)
KUD, KWD
Device Description
The implant is a fixation metal device, machined from implant quality cobalt-chrome alloy. The implant is cannulated to allow proper positioning. The stem is threaded and functions as a selfreaming and self-tapping screw for easy insertion. The shaft design is a duplicate of Vilex Cannulated Hemi Implant, K023684. The head is spherical and mirror-polished. The outside appearance resembles the STD Great Toe Resurfacing Hemi-Arthroplasty Implant, K031859. Use Only with Approved Bone Cement
Auxiliary instruments for implanting, aligning, countersinking come with "The Met-head."
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Metatarsal/Phalangeal (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): 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
Image /page/0/Picture/0 description: The image shows a logo for VILEX. The logo is in black and white and features a stylized font. The letters are bold and angular, with the "X" having a unique design where the right side extends beyond the left.
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|--------|--------------|
| Manufacturer of Vilex™ bone implants,
Power equipment & surgical instruments | Phone:
Fax:
www.vilex.com | (931) 474-7550
(931) 474-7551 | 111 Moffitt Street
McMinnville, TN 37110 USA
E-mail: info@vilex.com |
| --------------------------------------------------------------------------------- | --------------------------------- | ---------------------------------- | --------------------------------------------------------------------------- |
|---|
SUMMARY
V Pc
Met-Head™, Resurfacing Hemi-Arthroplasty Implant
The implant is a fixation metal device, machined from implant quality cobalt-chrome alloy. The implant is cannulated to allow proper positioning. The stem is threaded and functions as a selfreaming and self-tapping screw for easy insertion. The shaft design is a duplicate of Vilex Cannulated Hemi Implant, K023684. The head is spherical and mirror-polished. The outside appearance resembles the STD Great Toe Resurfacing Hemi-Arthroplasty Implant, K031859. Use Only with Approved Bone Cement
Auxiliary instruments for implanting, aligning, countersinking come with "The Met-head."
| Date of submission | December 26, 2006, rev4: March 13, 2007 |
|---|---|
| Type of submission | 510(k); K070052 |
| Reason for submissi | New Device |
| Product Code | KUD |
| Device Class | II |
| Classification Panel | Orthopedics |
| Predicate Devices: | |
| K023684 | Vilex |
| K031859 | STD Manufacturing |
| Common/Generic | Phalangeal (Hemi Toe) Prosthesis |
| Device Trade Name | Met-HeadTM |
| Establishment Reg. | 2529556 |
| Owner Operator No. | 9004058 |
| Establishment | Manufacturer |
| Operations | |
| Indication for Use | Hallux Limitus or Rigidus |
| Resurfacing of Arthritic /Metatarsal joint | |
| To fixate, use cement or press fit without cement |
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Vilex, Inc % Ms. Sylvia Southard President 111 Moffitt Street McMinnville, Tennessee 37110
MAR 2 8 2007
Re: K070052
Trade/Device Name: Met-Head™ Regulation Number: 21 CFR 888.3730 Regulation Name: Toe joint phalangeal (hemi-toe) polymer prosthesis Regulatory Class: Class II Product Code: KWD Dated: December 26, 2006 Received: January 10, 2007
Dear Ms. Southard:
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 - Ms. Sylvia Southard
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 Office of Compliance at (240) 276-0120 Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 vours.
Rarbaro Bueto
Mark N. elkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Image /page/3/Picture/0 description: The image shows the logo for VILEX Inc. The logo is in a bold, sans-serif font and is enclosed in a rectangular box. The word "Inc." is located to the right of the box.
| Manufacturer of Vilex™ bone implants,
| Power equipment & surgical instruments | |
|---|---|
| Phone: | (931) 474-7550 |
| Fax: | (931) 474-7551 |
| 111 Moffitt Street | |
| McMinnville, TN 37110 USA | |
| www.vilex.com | E-mail: info@vilex.com |
510 (K) NUMBER K070052
DEVICE NAME: Toe Joint, Phalangeal (Hemi Toe) Prosthesis, Trade Name "Met-Head™»
INDICATIONS FOR USE:
The Vilex "The Met-head", as designed, has the following Indications for Use:
Hallux Limitus or Rigidus Halux Valgus Metatarsal/Phalangeal (MTP) Joint To fixate, use cement or press fit without cement
Mark N Milkeuson
Prescription Use × (Per 21 CFR 801 Subpart D) Division of General, Restorative, and Neurological Devices
510(K) Number K076052
Concurrence of CDRH, Office of Device Evaluation (ODE)
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