(26 days)
Not Found
No
The summary describes a biodegradable screw for ACL/PCL reconstruction and explicitly states that AI, DNN, or ML are not mentioned.
Yes
The device is used for interference fixation in ligament reconstruction, which is a therapeutic intervention aimed at restoring function and improving the patient's condition.
No
Explanation: The device is an implantable screw used for fixation during ligament reconstruction, not for diagnosing medical conditions.
No
The device description clearly states it is a "Biodegradable ACL/PCL SCREW," which is a physical implant, 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.
- Device Description: The INION HEXALON™ BIODEGRADABLE ACL/PCL SCREW is an implantable device used for surgical fixation of ligaments during reconstruction. It is physically placed within the body.
- Intended Use: The intended use is for surgical interference fixation, not for analyzing biological samples.
The information provided clearly describes a surgical implant, not a device used for testing biological specimens outside of the body.
N/A
Intended Use / Indications for Use
The INION HEXALON™ BIODEGRADABLE ACL/PCL SCREW is intended for interference fixation in anterior and posterior cruciate ligament reconstruction using bone-tendon-bone or soft tissuc grafts.
Product codes
HWC
Device Description
Inion Hexalon™ Biodegradable ACL/PCL screws are intended to be used for interference fixation in anterior and posterior cruciate ligament reconstruction using bone-tendon-bone or soft tissue grafts.
The new screws are identical with the other implants in the previously 510(k) cleared Inion Hexalon™ Biodegradable ACL/PCL Screw (K021280) in terms of copolymer composition, colour additive, intended use and indications for use as described in the device labelling. manufacturing method and sterilization method.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
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.
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Kobo193
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MAR 1 3 2006
Image /page/0/Picture/2 description: The image shows a close-up of a logo with the word "INION" in large, bold white letters against a black background. Below the main word, the phrase "Intelligent Solution" is written in a smaller, sans-serif font, also in white. The overall design is simple and high-contrast, emphasizing the brand name.
SPECIAL 510(k) SUMMARY for the line extension of INION Hexalon ™ Biodegradable ACL/PCL Screw (K021280)
MANUFACTURER
Inion Ltd., Lääkärinkatu 2, FIN-33520 Tampere, FINLAND
Contact Person
Hanna Marttila, Regulatory Affairs Director Lääkärinkatu 2, FIN-33520 Tampere Phone: +358 3 2306 600 Fax: +358 3 2306 691 hanna.marttila@inion.com
DEVICE NAME
Trade name: Inion Hexalon™ Biodegradable ACL/PCL Screw Common/Usual Name: Biodegradable Interference Screw Classification Name: Bone Fixation Screw
ESTABLISHMENT REGISTRATION NUMBER 9710629
DEVICE CLASSIFICATION AND PRODUCT CODE
Classification panel: Orthopedic Regulation number: 21 CFR 888.3040 Regulation name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC
PREDICATE DEVICE Inion Hexalon™ Biodegradable ACL/PCL Screw (K021280)
CONFORMANCE WITH PERFORMANCE STANDARDS
No applicable mandatory performance standards exist for this device. Compliance to voluntary consensus standards is listed in the application.
THE REASON FOR SCPECIAL 510(k)
New screws to be added to Inion Hexalon™ Biodegradable ACL/PCL Screw (K021280).
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Image /page/1/Picture/0 description: The image shows a logo with the word "INION" in large, bold white letters against a black background. Below "INION" is the phrase "Intelligent Solution" in a smaller, white sans-serif font. The overall design is simple and high-contrast, emphasizing the brand name.
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DEVICE DESCRIPTION AND PRINCIPLES OF OPERATION
Inion Hexalon™ Biodegradable ACL/PCL screws are intended to be used for interference fixation in anterior and posterior cruciate ligament reconstruction using bone-tendon-bone or soft tissue grafts.
The new screws are identical with the other implants in the previously 510(k) cleared Inion Hexalon™ Biodegradable ACL/PCL Screw (K021280) in terms of copolymer composition, colour additive, intended use and indications for use as described in the device labelling. manufacturing method and sterilization method.
EQUIVALENCE TO MARKETED PRODUCTS
Based on the performance data and specifications presented, it can be concluded that the intended use, material composition and scientific technology, dogradation profile and substantially equivalent with the predicate device Inion Hexalon™ Biodegradable ACL/PCT. screw (K021280).
The new Inion Hexalon™ Biodegradable ACL/PCL screws are substantially equivalent (1) predicate Class II devices used for interference fixation in anterior and posterior cruciate ligament reconstruction using bone-tendon-bone or soft tissue grafts, because the differences between the new Inion Hexalon™ Biodegradable ACL/PCL screws and the predicate device do not raise new questions of safety and effectiveness.
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Image /page/2/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 words "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure with three wavy lines extending from its head.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 3 2006
Inion Limited c/o Ms. Hanna Marttila Regulatory Affairs Director Laakarinkatu 2 Fin-33520 Tampere Finland
Re: K060393
Trade/Device Name: Inion Hexalon™ Biodegradable ACL/PCL Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: February 13, 2006 Received: February 15, 2006
Dear Ms. Marttila:
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
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Page 2 – Ms. Hanna Marttila
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. 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 _ prarketed 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Helut Zemer
Mark N. Melkerson Acting 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: K060393
Device Name: Inion Hexalon™ Biodegradable ACL/PCL Screw
Indications:
The INION HEXALON™ BIODEGRADABLE ACL/PCL SCREW is intended for interference fixation in anterior and posterior cruciate ligament reconstruction using bone-tendon-bone or soft tissuc grafts.
Contraindications:
The INION HEXALON™ BIODEGRADABLE ACL/PCL SCREW is contraindicated in casc of :
-
Insufficient quality or quantity of bone for interference screw attachment
-
Active or potential infections
-
Patient conditions including limited blood supply, chronic disease which causes insufficient quality of bone, and where patient cooperation cannot be guaranteed (e.g. alcoholism, drug abuse)
Prescription Use Yes (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use No (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hichard Lunn
Division of General, Restorative, and Neurological Devices
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510(k) Number K060393