(86 days)
Not Found
No
The device description and intended use focus on a biodegradable screw for ligament reconstruction, with no mention of AI or ML capabilities.
No
A therapeutic device is one that treats or cures a disease or condition. This device is used for interference fixation in ligament reconstruction, which is a structural support rather than a direct treatment or cure.
No.
The device is an implant for interference fixation in ligament reconstruction, not for diagnosis.
No
The device description clearly states it is a physical screw made of resorbable copolymers, indicating it is a hardware medical device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "interference fixation in anterior and posterior cruciate ligament reconstruction using bone-tendon-bone or soft tissue grafts." This describes a surgical procedure performed in vivo (within the living body).
- Device Description: The description details a physical implantable device (a screw) made of biodegradable materials. This is a medical device used directly on the patient during surgery.
- Lack of IVD Characteristics: An IVD is used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information about a person's health. This device does not perform any such analysis.
The information provided describes a surgical implant, which falls under the category of a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Inion Hexalon™ Biodegradable ACL/PCL Screw is intended to be used for interference fixation in anterior and posterior cruciate ligament reconstruction using bone-tendon-bone or soft tissue grafts.
The Inion Hexalon™ Biodegradable ACL/PCL Screw is intended for use The in anterior/posterior cruciate ligament (ACL/PCL) reconstruction procedures. The Inion Hexalon™ Biodegradable ACL/PCL Screw is indicated for fixation of bone-patellar tendonbone graft to the femoral/tibial bone drill hole in the anterior cruciate ligament reconstruction, fixation of the soft tissue graft to the femoral/tibial bone drill hole in the anterior cruciate ligament (ACL) reconstruction and reconstruction of posterior cruciate ligament (PCL)
Product codes
HWC
Device Description
The Inion Hexalon™ Biodegradable ACL/PCL Screw is made of resorbable polylactic acid / trimethylenecarbonate copolymers and it is provided in the various lengths and diameters typical of the other marketed devices. The Inion Hexalon™ Biodegradable ACL/PCL Screw is offered both undyed and coloured for better visualization during surgical operation. Colour additive used for dying the device is FDA approved colourant: D&C Green No.6, in accordance with the Title 21 CFR 74.3206. The Inion Hexalon™ Biodegradable ACL/PCL Screws gradually lose their strength during 18-36 weeks. Bioresorption takes place within two to four years.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral/tibial bone drill hole in the anterior cruciate ligament, posterior cruciate ligament
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)
Mechanical testing demonstrates that the device is substantially equivalent to the predicate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K973758, K971358, K982497, K983592
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
JUL 1 7 2002
K021280 page 12
Image /page/0/Picture/2 description: The image shows a logo for a company called INION. The logo is in white text on a black background. Below the company name is the tagline "Intelligent Solution" in a smaller font size. The logo has a simple, modern design.
510(k) SUMMARY for the Inion Hexalon™ Biodegradable ACL/PCL Screw
MANUFACTURER
Inion Ltd. Lääkärinkatu 2 FIN-33520 Tampere
Contact Person: Hanna Marttila Regulatory Affairs Manager Lääkärinkatu 2 FIN-33520 Tampere Phone: +358 3 2306 600 Fax: +358 3 2306 601 hanna.marttila@inion.fi
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 Regulatory Class: Class II 21 CFR 888.3040 - Smooth or threaded metallic bone fixation fastener, 87-HWC
PREDICATE DEVICES
Linvatec Corporation; BioScrew® Absorbable Interference Screw (K973758) Arthrex, Inc .; The Arthrex Bio-Interference Screw (K971358) Biomet Inc .; Arthrotek Interference Screw (K982497) Sulzer Orthopedics Inc .; Sysorb Interference Screw (K983592)
Date:19.4.2002 Status: Final
1
DEVICE DESCRIPTION AND PRINCIPLES OF OPERATION
Inion Hexalon™ Biodegradable ACL/PCL Screw is intended for use The in anterior/posterior cruciate ligament (ACL/PCL) reconstruction procedures. The Inion Hexalon™ Biodegradable ACL/PCL Screw is indicated for fixation of bone-patellar tendonbone graft to the femoral/tibial bone drill hole in the anterior cruciate ligament reconstruction, fixation of the soft tissue graft to the femoral/tibial bone drill hole in the anterior cruciate ligament (ACL) reconstruction and reconstruction of posterior cruciate ligament (PCL)
The Inion Hexalon™ Biodegradable ACL/PCL Screw is made of resorbable polylactic acid / trimethylenecarbonate copolymers and it is provided in the various lengths and diameters typical of the other marketed devices. The Inion Hexalon™ Biodegradable ACL/PCL Screw is offered both undyed and coloured for better visualization during surgical operation. Colour additive used for dying the device is FDA approved colourant: D&C Green No.6, in accordance with the Title 21 CFR 74.3206. The Inion Hexalon™ Biodegradable ACL/PCL Screws gradually lose their strength during 18-36 weeks. Bioresorption takes place within two to four years.
EQUIVALENCE TO MARKETED PRODUCTS
The Inion Hexalon™ Biodegradable ACL/PCL Screw is substantially equivalent to the biodegradable screws, intended for ACL and PCL reconstruction procedures, which have received 510(k) clearance. The Inion Hexalon™ Biodegradable ACL/PCL Screw and BioScrew® Absorbable Interference Screw (K973758), The Arthrex Bio-Interference Screw (K971358), Arthrotek Interference Screw (K982497) and Sysorb Interference screw (K983592) have the same intended use and principles of operation and very similar design characteristics. Mechanical testing demonstrates that the device is substantially equivalent to the predicate. The differences between the Inion Hexalon™ Biodegradable ACL/PCL Screw and these predicate devices do not raise new questions of safety and effectiveness.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake entwined around it, overlaid on three human profiles. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 7 2002
Ms. Hanna Marttila Regulatory Affairs Manager Inion Ltd. Lääkärinkatu 2 FIN-33520 Tampere Finland
Re: K021280
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: April 19. 2002 Received: April 22, 2002
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 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.
3
Page 2 - Ms. Hanna Marttila ·
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
Mark N. Melkerson
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
4
Page 1 of 1
STATEMENT OF INDICATIONS FOR USE
Applicant: Inion Ltd. Applicant. Imon Ltd.
510(k) Number: KOL(ノピ Device Name: Inion Hexalon™ Biodegradable ACL/PCL Screw
Indications:
ﺎ ﻓﻲ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ
The Inion Hexalon™ Biodegradable ACL/PCL Screw is intended to be used for interference fixation in anterior and posterior cruciate ligament reconstruction using bone-tendon-bone or soft tissue grafts.
Contraindications:
- Insufficient quality or quantity of bone for interference screw attachment
-
- Active or potential infection
- 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)
Over the Counter use _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ Prescription use
Concurrence of CDRH, Office of Device Evaluation (ODE) (Per 21 CFR 801.109)
Mark N Mellzer
Division Sign-()ff) Division of General, Restorative and Neurological Devices
510(k) Number -
Date:17.4.2002 Status: Final