(73 days)
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No
The summary describes a bone plate for internal fixation and contains no mention of AI, ML, image processing, or performance studies related to algorithmic analysis.
No
The device is an internal fixation plate used in surgery, which is a structural implant and not a therapeutic device designed for treating or healing a condition through non-surgical means.
No
Explanation: The device, the VariAx™ Distal Lateral Fibula Plate, is intended for internal fixation of the distal fibula. This is a therapeutic function (fixing a bone), not a diagnostic one (identifying a condition or disease).
No
The device description clearly states it is a "VariAx™ Distal Lateral Fibula Plate," which is a physical implant used for internal fixation. This is a hardware device, not software.
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. This testing is done outside of the body (in vitro).
- Device Description: The VariAx™ Distal Lateral Fibula Plate is described as a device for internal fixation of the distal fibula. This means it is surgically implanted inside the body to stabilize a bone fracture.
- Intended Use: The intended use is for internal fixation, which is a surgical procedure, not a diagnostic test performed on a specimen.
The information provided clearly indicates this is a surgical implant, not a device used for laboratory testing of biological samples.
N/A
Intended Use / Indications for Use
The VariAx™ Distal Lateral Fibula Plate is intended for use in internal fixation of the distal fibula.
Product codes
KTT
Device Description
This submission is a line extension to the Stryker® Plating System. The components of the VariAx™ Distal Fibula Plate are intended to add a different type of plate to the Stryker® Plating System portfolio.
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
distal fibula
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
Not Found
Key Metrics
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Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
510(k) Summary of Safety and Effectiveness VariAx™ Distal Fibula Plate
| Proprietary Name: | VariAx ™ Distal Fibula Plate
JUL 18 2008 |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Bone plates and screws |
| Classification Name/Reference: | Single/multiple component metallic bone fixation
appliances and accessories, 21 CFR §888.3030 |
| Device Product Code: | 87 KTT |
| Proposed Regulatory Class: | Class II |
| For Information contact: | Andrea Dwyer, Regulatory Affairs Associate
Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah, NJ 07430
Phone: (201) 831-6250 Fax: (201) 831-6038 |
| Date Summary Prepared: | May 5, 2008 |
Description:
This submission is a line extension to the Stryker® Plating System. The components of the VariAx™ Distal Fibula Plate are intended to add a different type of plate to the Stryker® Plating System portfolio.
Indications:
The VariAx™ Distal Lateral Fibula Plate is intended for use in internal fixation of the distal fibula.
Substantial Equivalence:
The VariAx™ Distal Fibula Plate is substantially equivalent to the Stryker® Foot, Profyle®, Universal Distal Radius System, and the Synthes® Small Fragment Locking Compression Plate (LCP) System in regards to intended use, design, materials, and operational principles as a fracture plating system.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Howmedica Osteonics Corp. % Ms. Andrea Dwyer Regulatory Affairs Associate 325 Corporate Drive Mahwah, NJ 07430
JUL 1 8 2008
Re: K081284 Trade/Device Name: VariAx™M Distal Fibula Plate Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation Appliances and accessories Regulatory Class: Class II Product Code: KTT Dated: May 5, 2008 Received: May 6, 2008
Dear Ms. Dwyer:
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 promotions 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Ms. Andrea Dwyer
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 M. Milliman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): YD81284
Device Name: VariAx™ Distal Fibula Plate
Indications for Use:
The VariAx™ Distal Lateral Fibula Plate is intended for use in internal fixation of the distal fibula.
Over-The-Counter Use Prescription Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Seubone Buchanan Jr. npxu
Division Sign-Off
Division of General, Restorative, and Neurological Devices
510(k) Number K081284