K Number
K041287
Device Name
VILEX BONE PLATE SYSTEM
Manufacturer
Date Cleared
2004-08-05

(84 days)

Product Code
Regulation Number
888.3040
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Small-Bone Fracture and Osteotomy in Upper & Lower Extremities, primarily hand, foot, and digits.
Device Description
The material used to manufacture the bone plates is implant-quality 316L Stainless (ASTM Fric material used to manufacture (ASTM F-136). The plates are to be used with accompanying bone screws of the same material.
More Information

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Not Found

No
The summary describes a bone plate and screw system made of standard implant materials, with no mention of software, image processing, or AI/ML terms.

Yes
The device is a bone plate and screws, which are used to stabilize fractures and osteotomies, directly treating a medical condition.

No
The device description indicates it is a bone plate and accompanying screws for fracture and osteotomy treatment, which are therapeutic interventions rather than diagnostic tools.

No

The device description explicitly states it is made of implant-quality 316L Stainless and includes bone plates and screws, indicating it is a physical hardware device.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is for "Small-Bone Fracture and Osteotomy in Upper & Lower Extremities, primarily hand, foot, and digits." This describes a surgical implant used to stabilize bones, not a test performed on samples taken from the body to diagnose a condition.
  • Device Description: The device is described as bone plates and screws made of implant-quality materials. This is consistent with a surgical implant, not an IVD.
  • Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
    • Analyzing samples (blood, urine, tissue, etc.)
    • Detecting or measuring substances in samples
    • Providing information for diagnosis, monitoring, or screening

Therefore, this device falls under the category of a surgical implant or orthopedic device, not an In Vitro Diagnostic.

N/A

Intended Use / Indications for Use

Small-Bone Fracture and Osteotomy in Upper & Lower Extremities, primarily hand, foot, and digits.

Product codes

HWC

Device Description

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Mentions image processing

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Mentions AI, DNN, or ML

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Input Imaging Modality

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Anatomical Site

Upper & Lower Extremities, primarily hand, foot, and digits.

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.

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

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.

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Image /page/0/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 caduceus, a symbol often associated with medicine and healthcare, with three parallel lines forming the staff and a stylized bird-like figure at the top. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.

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: K041287

Trade/Device Name: Vilex Bone Plate Systems 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 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.

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) 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 (301) 594-4659. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours,

Mark H. Milliken

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

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Image /page/2/Picture/0 description: The image shows the word "VILEX" in a stylized, bold font, with the letters connected and slightly slanted. Below the word "VILEX" is the word "Inc.", which is an abbreviation for Incorporated. The text is black and is set against a white background.

Manufacturer of Vilex™ bone implants, Power equipment & surgical instruments. Phone: (412) 655-7550 FAX: (412) 655-7551 www.vilex.com

345 Old Curry Hollow Road Pittsburgh, PA 15236 USA E-mail: info@vilex.com

510 (K) NUMBER K 041687

DEVICE NAME: Vilex Bone Plate Systems

INDICATIONS FOR USE:

The Vilex Bone Plates have the following Indications for Use:

Small-Bone Fracture and Osteotomy in Upper & Lower Extremities, primarily hand, foot, and digits.

Contra Indications: Elbow, Shoulder, Knee, Hip, Spine, Neck, & Skull

The material used to manufacture the bone plates is implant-quality 316L Stainless (ASTM Fric material used to manufacture (ASTM F-136). The plates are to be used with accompanying bone screws of the same material.

Prescription Use _x (Per 21 CFR 801.109)

Concurrence of CDRH, Office of Device Evaluation (ODE

f Device Evaluation (ODE)

Mark N Mulkern

Page __ 1 __ of ______________________________________________________________________________________________________________________________________________________________ 1

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510(k) Number K041287