(84 days)
Not Found
No
The summary describes a titanium implant for flat foot and pronated subtalar joint, with no mention of AI, ML, image processing, or data sets typically associated with AI/ML devices.
Yes
The device is described as an implant used for treating flat foot and pronated subtalar joint, indicating it performs a therapeutic function.
No
The provided information describes an implantable device made of titanium for flat foot and pronated subtalar joint, which is a treatment device, not a diagnostic one. There is no mention of it being used to detect, identify, or characterize a disease or condition.
No
The device description explicitly states the device is made of implant-quality titanium alloy and is intended to be implanted, indicating it is a physical hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is for treating flat foot and pronated subtalar joint, which are conditions related to the musculoskeletal system.
- Device Description: The device is an implant made of titanium intended to be surgically placed within the body.
- Anatomical Site: The device is implanted in the Talus, a bone in the foot.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a physiological state, health, or disease.
IVDs are used to perform tests on samples taken from the human body to diagnose, monitor, or screen for diseases or conditions. This device is a surgical implant used to correct a structural issue within the body.
N/A
Intended Use / Indications for Use
The Talus of Vilex, as designed, has the following Indications for Use: Flat foot, pronated subtalar joint.
The material used to manufacture this device is implant-quality titaniumTl6A4V alloy. The device is intended to remain implanted for a finite period of time. The implant is best device is ifitended to remain implanted for a minto for a minto for single use only.
Prescription Use (Per 21 CFR 801.109)
Product codes
HWC
Device Description
The Talus of Vilex, as designed, has the following Indications for Use: Flat foot, pronated subtalar joint. The material used to manufacture this device is implant-quality titaniumTl6A4V alloy. The device is intended to remain implanted for a finite period of time. The implant is best device is ifitended to remain implanted for a minto for a minto for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
subtalar joint, foot
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an emblem featuring a stylized eagle with its wings spread, symbolizing the department's mission to protect and promote the health and well-being of the nation.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 5 2004
Abraham Lavi, Ph.D., MBA President Vilex, Inc. 345 Old Curry Hollow Road Pittsburgh, Pennsylvania 15236
Re: K041289
Korr20>
Trade/Device Name: Talus of Vilex (TOV) Implant
Regulation Number: 21 CFR 888.3040
Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: May 10, 2004 Received: May 24, 2004
Dear Dr. Lavi:
We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your becaon 3 rQury premier is substantially equivalent (for the indications felerenced above and nave determined by marketed predicate devices marketed in interstate for use stated in the encrosuly to regars manetter for the Medical Device Amendments, or to commerce prior to May 26, 1976, the encordance with the provisions of the Federal Food. Drug. devices that have been reclassified in accee approval of a premarket approval application (PMA). and Cosmelle Act (Act) that do not require approvisions of the general controls provisions of the Act. The You may, merciole, market the de recurements for annual registration, listing of general controls provisions of the rest labeling, and prohibitions against misbrandirg and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it II your device is classified (300 above) into existing major regulations affecting your device can
may be subject to such additional controls. Existing major and division FD Inay be subject to sublications, Title 21, Parts 800 to 898. In addition, FDA may be found in the Ood of I sacra concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I Dri 3 issualse of our device complies with other requirements of the Act that I DA has made a acternment administered by other Federal agencies. You must or any Federal statutes and regulations daminding, but not limited to: registration and listing (21 comply with an the Act 31equirements) (1); good manufacturing practice requirements as set CFK Fatt 807), labeling (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
Page 2 – Abraham Lavi, Ph.D., MBA
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin maneting your antial equivalence of your device to a legally premarket notification. The PDA miding of basification 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 ac now on our case. Also, please note the regulation entitled, Colliact the Office of Complanes at (Sot notification" (21CFR Part 807.97) You may obtain Misoranding of reference to premientonibilities under the Act from the Division of Small other general international and Consumer 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 Milligan
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 bold, stylized font. The letters are connected and have a sharp, angular 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) 655-7551 FAX: www.vilex.com
345 Old Curry Hollow Road Pittsburgh, PA 15236 USA E-mail: info@vilex.com
510 (K) NUMBER K041124
DEVICE NAME: TALUS OF VILEX (TOV) IMPLANT
INDICATIONS FOR USE:
The Talus of Vilex, as designed, has the following Indications for Use:
Flat foot, pronated subtalar joint.
The material used to manufacture this device is implant-quality titaniumTl6A4V alloy. The device is intended to remain implanted for a finite period of time. The implant is best device is ifitended to remain implanted for a minto for a minto for single use only.
Prescription Use
(Per 21 CFR 801.109)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark N Mikkelsen
Division of General. Restorative. and Neurological Devices
6.1 510(k) K041384
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