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.

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.

AI/ML Overview

This document is a marketing approval for a medical device (510(k) clearance) rather than a study report with detailed performance data or acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and a study proving performance cannot be extracted directly from the provided text.

Specifically, the document states: "No applicable mandatory performance standards exist for this device. Compliance to voluntary consensus standards is listed in the application." This indicates that there are no specific, quantitative acceptance criteria for device performance laid out in this clearance document. Instead, the clearance relies on demonstrating substantial equivalence to a predicate device.

Here's what can be extracted from the provided text, and what cannot:

1. A table of acceptance criteria and the reported device performance

Cannot be provided. The document does not specify quantitative acceptance criteria or detailed reported device performance in terms of metrics like accuracy, sensitivity, or specificity. It focuses on demonstrating substantial equivalence.

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

Cannot be provided. The document describes a "510(k) summary for the line extension" and states "Based on the performance data and specifications presented, it can be concluded that the intended use, material composition and scientific technology, degradation profile and substantially equivalent with the predicate device". This implies performance data was presented elsewhere in the full 510(k) application, but it is not detailed in this summary. There is no mention of a "test set" in the context of a study demonstrating performance.

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)

Cannot be provided. Not applicable as no specific test set and ground truth establishment process is described.

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

Cannot be provided. Not applicable as no specific test set and ground truth establishment process is described.

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

Cannot be provided. This device is a biodegradable orthopedic screw, not an AI-powered diagnostic device. Therefore, an MRMC study or AI assistance is not relevant or applicable.

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

Cannot be provided. This device is a physical medical implant, not an algorithm. Standalone performance as typically described for software or AI devices is not relevant.

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

Cannot be provided. The concept of "ground truth" as used in algorithm performance evaluation does not directly apply to the approval of an orthopedic implant based on substantial equivalence. The "truth" in this context relates to the safety and effectiveness of the device compared to a legally marketed predicate.

8. The sample size for the training set

Cannot be provided. This device is a physical implant, not an AI model requiring a training set.

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

Cannot be provided. Not applicable to this type of device.

Summary of what the document implies about "meeting criteria":

The device meets the acceptance criteria by demonstrating substantial equivalence to an already approved predicate device (Inion Hexalon™ Biodegradable ACL/PCL Screw, K021280).

The study that proves the device meets the criteria (i.e., is substantially equivalent) is inferred from the statement: "Based on the performance data and specifications presented, it can be concluded that the intended use, material composition and scientific technology, degradation profile and substantially equivalent with the predicate device Inion Hexalon™ Biodegradable ACL/PCT. screw (K021280)."

The "performance data and specifications presented" would have been part of the full 510(k) submission, but are not detailed in this summary. They would typically involve:

Material composition analysis: Ensuring the new screws use the same copolymer and color additive.
Mechanical testing: Demonstrating that the new screws have comparable mechanical strength, fatigue resistance, and interference fixation properties to the predicate.
Degradation profile studies: Showing that the degradation rate and byproducts are similar to the predicate device.
Biocompatibility testing: As required for implants, although often covered by the predicate if materials are identical.
Manufacturing and sterilization method consistency: Confirmation that these are identical to the predicate.

The acceptance criterion for approval in this context is the FDA's determination that the new devices do "not raise new questions of safety and effectiveness" compared to the predicate device, thereby confirming substantial equivalence under 21 CFR 807.92(a)(3). The "study" is the entirety of the data and analysis provided in the 510(k) submission to support this claim of substantial equivalence.

Summary

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Kobo193

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MAR 1 3 2006

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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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DEVICE DESCRIPTION AND PRINCIPLES OF OPERATION

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

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.