(486 days)
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Not Found
No
The summary describes a metallic implant and its intended use, material, and anatomical site. There is no mention of AI, ML, image processing, or any data-driven analytical capabilities typically associated with AI/ML medical devices.
Yes
The device is a metallic toe implant intended for conditions like Hallux Limitus/Rigidus and joint arthroplasty, indicating its purpose in treating or alleviating a medical condition.
No
Explanation: The document describes a toe implant intended for treatment of various foot conditions, not for diagnosing them. It is a prosthetic device.
No
The device description explicitly states it is a "Cannulated Metallic Toe Implant" made of "implant-quality cobalt-chrome alloy ASTM F75," which is a physical hardware component.
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, or tissue) to provide information about a person's health.
- Device Description: The description clearly states this is a "Cannulated Metallic Toe Implant" made of cobalt-chrome alloy. It's a physical implant designed to be surgically placed in the toe joint.
- Intended Use: The intended uses are related to treating conditions of the toe joint (Hallux Limitus/Rigidus, Hallux Valgus, Joint Arthroplasty, Resurfacing). These are surgical procedures, not diagnostic tests performed on specimens.
This device is a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
The Cannulated Metallic Toe Implant, as designed, has the following Indications for Use:
Hallux Limitus or Hallux Rigidus, Hallux Valgus, Joint Arthroplasty, Resurfacing of Arthritic M-P Joints.
Product codes (comma separated list FDA assigned to the subject device)
KWD
Device Description
The material used to manufacture this prosthesis is implant-quality cobalt-chrome alloy ASTM F75. The implant may be cemented to the phalanx or press-fit without cement.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Toe (specifically M-P Joints, Hallux)
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.
Not Found
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and 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 image of an eagle with three stripes representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 1 2004
Abrahim Lavi, Ph.D., MBA President Vilex, Inc. 345 Old Curry Hollow Road Pittsburg, Pennsylvania 15236
Rc: K023684
. 1802500 For Name: Cannulated Metallic Hemi Toe Implant Regulation Number: 21 CFR 888.3730 Regulation Name: Toe joint phalangeal (hemi-toe) polymer prosthesis Regulatory Class: Il Product Code: KWD Dated: December 29, 2003 Received: January 8, 2004
Dear Dr. Lavi:
We have reviewed your Section 510(k) premarket notification of intent to market the device indicati we nave reviewed your becamed the device is substantially equivalent (for the indications ferenced above and nave determined the marketed predicate devices marketed in interstate for use stated in the encrosary w regars and the Medical Device Amendments, or to commerce province way 20, 1978, the exactions 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 I ou may, merciolo, manel the Act include requirements for annual registration, listing of general controls provisions of ractice, 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 If your device is elassince (600 wor of ols. Existing major regulations affecting your device can may be subject to sublications, Title 21, Parts 800 to 898. In addition, FDA may oublish further announcements concerning your device in the Federal Register.
Please be advised that FDA`s issuance of a substantial equivalence determination does not mean Flease be advised that I DA 3 issuance or our device complies with other requirements of the Act that I DX has made a acteriminations administered by other Federal agencies. You must or any it caefar statuted and registements, including, but not limited to: registration and listing (21 Compry with an the Her STOC STORES, 10, good manufacturing practice requirements as set CI K I all 607), navelling (21 CFR Part 820); and if applicable, the electronic forth in the quality bystems (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
Page 2 - Abrahim Lavi, Ph.D., MBA
This letter will allow you to begin marketing your device as described in your Section 5 10(k) I his letter will anow you to begin maneting your aviate of your dever to a legally premaince nothleadon: The FDA maing of easification 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 If you desire specific advice for your act (301) 594-4659. Also, please note the regulation entitled, Comaci the Office of Comphance at (3st notification" (21CFR Part 807.97). You may obtain "Misoranuming by reference to premainters inculties under the Act from the Division of Small other general information on your response Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark N Milken
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Image /page/2/Picture/0 description: The image shows the logo for VILEX Inc. The logo is in black and white and features the word "VILEX" in a stylized font. The letters are bold and angular, and the "X" has a unique design. To the right of the logo is the word "Inc."
Manufacturer of Vilex™ bone implants, Power equipment & surgical instruments. Phone: (412) 655-7550 (412) 655-755) FAX: www.vilex.com
345 Old Curry Hollow Road Pittsburgh, PA 15236 USA E-mail: info@vilex.com
510 (K) NUMBER K023684
DEVICE NAME: CANNULATED METALLIC HEMI TOE IMPLANT
INDICATIONS FOR USE:
The Cannulated Metallic Toe Implant, as designed, has the following Indications for Use:
Hallux Limitus or Hallux Rigidus, Hallux Valgus, Joint Arthroplasty, Resurfacing of Arthritic M-P Joints.
The material used to manufacture this prosthesis is implant-quality cobalt-chrome alloy ASTM F75. The implant may be cemented to the phalanx or press-fit without cernent.
Prescription Use
(Per 21 CFR 801.109) X
Concurrence of CDRH, Office of Device Evaluation (ODE)
page 1 of 1, Revised 12/29/03
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number K023684