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.

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.

AI/ML Overview

The provided text describes a 510(k) summary for a medical device, the Inion Hexalon™ Biodegradable ACL/PCL Screw. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a dedicated study.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and MRMC studies are not present in this document because they are typically required for performance studies, not for 510(k) substantial equivalence submissions.

Here's a breakdown of the available information:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Not explicitly defined in terms of quantitative performance metrics for the device itself.	Mechanical testing demonstrated substantial equivalence to predicate devices. The device gradually loses strength over 18-36 weeks and bioresorbs within two to four years.
Substantial equivalence to predicate devices (Linvatec BioScrew®, Arthrex Bio-Interference Screw, Arthrotek Interference Screw, Sysorb Interference Screw) in terms of intended use, principles of operation, and similar design characteristics. (Implied Acceptance Criteria)	The Inion Hexalon™ Biodegradable ACL/PCL Screw was found substantially equivalent to the listed predicate devices.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample size for test set: Not specified. The document states "Mechanical testing demonstrates that the device is substantially equivalent to the predicate," but does not provide details on the number of samples tested.
Data provenance: Not specified. The manufacturer is Inion Ltd., based in Tampere, Finland.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable/Not specified. Ground truth establishment with experts is usually relevant for diagnostic devices or those requiring subjective assessment. For a mechanical device demonstrating equivalence, expert consensus on performance metrics is not typically the primary method.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Not specified. Adjudication methods are typically used in studies involving subjective interpretation of data (e.g., medical images). Mechanical testing typically relies on objective measurements.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. This type of study (MRMC, AI assistance) is not applicable to an orthopedic fixation screw primarily evaluated for mechanical equivalence.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No. This is not an algorithm-based device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The implicit "ground truth" used for demonstrating substantial equivalence was the established performance and safety profile of the predicate devices, as assessed through mechanical testing. The document states, "Mechanical testing demonstrates that the device is substantially equivalent to the predicate," implying direct comparison of measured mechanical properties against those of the predicate devices or accepted standards for such devices.

8. The sample size for the training set

Not applicable/Not specified. This is not a machine learning or AI device that requires a "training set."

9. How the ground truth for the training set was established

Not applicable. This is not a machine learning or AI device.

Summary

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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

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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)

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.

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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.

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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

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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

Contraindications:

Insufficient quality or quantity of bone for interference screw attachment

1. 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

Regulation Number and Section

§ 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.