The Inion Hexalon™ Biodegradable ACL/PCL Screw is intended for soft tissue (including ligament, tendon, and bone-tendon-bone graft) fixation to bone in surgeries of the knee, shoulder, elbow, ankle, foot, hand and wrist where the offered screw sizes are patient appropriate.

Device Description

Inion Hexalon™ Biodegradable ACL/PCL Screw is made of resorbable polylactic acid / trimethylenecarbonate copolymer. The Inion Hexalon™ Biodegradable Screws are coloured green for better visualization during surgical operation.

Inion Hexalon™ Biodegradable ACL/PCL Screws gradually lose their strength during 18-36 weeks. Bioresorption takes place within two to four years. Inion Hexalon™ Biodegradable ACL/PCL Screw is sterile and non-collagenous. The shelf life of the product is three years.

AI/ML Overview

This document is a 510(k) summary for the Inion Hexalon™ Biodegradable ACL/PCL Screw, a medical device for orthopedic fixation. It does not contain information about acceptance criteria or a study proving the device meets them in the way a diagnostic AI would.

This 510(k) summary focuses on demonstrating substantial equivalence to predicate devices already on the market, rather than proving the performance of a novel diagnostic algorithm against specific acceptance criteria. This process is common for medical devices.

Therefore, many of the requested categories for a diagnostic AI study on acceptance criteria and performance cannot be directly extracted from this document, as they are not applicable to the type of regulatory submission presented.

Here's a breakdown of what can be derived from the provided text, and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

Not applicable / Not provided in this format. This document does not present acceptance criteria or reported performance as it would for a diagnostic AI. The goal of a 510(k) is to show substantial equivalence to existing devices. The "performance" is implicitly deemed equivalent to the predicate devices.
The closest "performance" related information is that the device "gradually lose their strength during 18-36 weeks" and "Bioresorption takes place within two to four years." These are characteristics, not performance metrics against acceptance criteria.

2. Sample Size Used for the Test Set and Data Provenance:

Not applicable. This is a medical implant, not a diagnostic AI that uses a test set of data. The "study" mentioned here is the comparison to predicate devices and the characterization of the material properties described above.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable. Again, this is not a diagnostic AI performance study.

4. Adjudication Method for the Test Set:

Not applicable.

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:

Not applicable. This is not a diagnostic AI and therefore no MRMC study would be conducted in this context.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

Not applicable in the context of an AI ground truth. For this device, the "ground truth" for substantial equivalence relies on:
- Material composition: Polylactic acid / trimethylenecarbonate copolymer.
- Scientific technology: Biodegradable screw for fixation.
- Degradation profile: 18-36 weeks for strength loss, 2-4 years for bioresorption.
- Mechanical properties: Implied to be similar to predicate devices.
- Predicate devices: Arthrex Interference Screw, Arthrex Tenodesis Screw Family, Biomet Bio-Core Interference Screw, Biomet Resorbable Interference Screw. The "ground truth" for their safety and effectiveness is their prior FDA clearance and market history.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/ML device that requires a training set.

9. How the Ground Truth for the Training Set was Established:

Not applicable.

Summary of what can be extracted concerning "acceptance criteria" and "study" for this type of device:

The "study" presented in this 510(k) is primarily a comparative study for substantial equivalence to previously cleared predicate devices.

Acceptance Criteria for Substantial Equivalence (Implicit from the document):

The device is considered to have met "acceptance criteria" for marketing if it is demonstrated to be substantially equivalent to predicate devices, meaning:

Same intended use: Soft tissue (ligament, tendon, bone-tendon-bone graft) fixation to bone in surgeries of the knee, shoulder, elbow, ankle, foot, hand, and wrist.
Similar technological characteristics: Material composition (resorbable polylactic acid/trimethylenecarbonate copolymer), degradation profile, and mechanical properties are comparable to predicate devices.
No new questions of safety and effectiveness: The differences between the Inion Hexalon™ screw and the predicate devices do not raise new concerns.

The "Study" that Proves the Device Meets these Criteria:

The "study" is a technical and scientific comparison to predicate devices, backed by information on the device's material properties and degradation profile.
The document states: "The evidence demonstrates that the intended use, material composition and scientific technology, degradation profile and mechanical properties of Inion Hexalon™ Biodegradable ACL/PCL Screw are substantially equivalent with the predicate devices."
Data Provenance: This would typically involve laboratory testing of the Inion Hexalon™ screw's material and mechanical properties (e.g., strength testing, degradation studies) and a review of the predicate devices' characteristics. The document does not specify where these tests were conducted or the specific experimental design, but it implies such data was submitted to the FDA to support the substantial equivalence claim.
No specific sample sizes for "test sets" or "training sets" are provided because this is not a diagnostic AI or a clinical trial in the conventional sense of proving efficacy or safety from scratch. Instead, it relies on the established safety and efficacy of the predicate devices.

Summary

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510(k) SUMMARY

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K071464 pg. 192

Inion Hexalon™ Biodegradable ACL/PCL Screw

AUG - 3 2007

Manufacturer and submitter Inion Oy, Lääkärinkatu 2, FIN-33520 Tampere, FINLAND

Contact Person

Kati Marttinen. Regulatory Affairs Specialist Phone: +358 10 830 6600 Fax: +358 10 830 6691 kati.marttinen@inion.com

Establishment registration number 9710629

Trade name of the device Inion Hexalon™ Biodegradable ACL/PCL Screw

Device classification and product code

Class II Classification Panel: Orthopedic Product Code: HWC Common name: Biodegradable Interference Screw Regulation number: 21 CFR 888.3040

Predicate devices

Arthrex Interference Screw (K062466) Arthrex Tenodesis Screw Family (K041356) Biomet Bio-Core Interference Screw (K042552) Biomet Resorbable Interference Screw (K041274)

Conformance with performance standards

No applicable mandatory performance standards exist for this device. Compliance to voluntary consensus standards is listed in the application.

Device description and principles of operation

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Inion Hexalon™ Biodegradable ACL/PCL Screw

Indications for use

The Inion Hexalon™M Biodegradable ACL/PCL Screw is intended for soft tissue (including ligament, tendon, and bone-tendon-bone graft) fixation to bone in surgeries of the knee, shoulder, elbow, ankle, foot, hand and wrist where the offered screw sizes are patient appropriate.

Substantial equivalence to marketed products

The evidence demonstrates that the intended use, material composition and scientific technology, degradation profile and mechanical properties of Inion Hexalon™ Biodegradable ACL/PCL Screw are substantially equivalent with the predicate devices.

Inion Hexalon™ Biodegradable ACL/PCL Screw is substantially equivalent to predicate Class II devices, when used for soft tissue (including ligament, tendon, and bone-tendonbone graft) fixation to bone in surgeries of the knee, shoulder, elbow, ankle, foot, hand and wrist where the offered screw sizes are patient appropriate, because the differences between Inion Hexalon™ Biodegradable ACL/PCL Screw and the predicate devices 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 & Human Services. The logo consists of a stylized image of an eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG = 3 2007

Inion Oy % Ms. Kati Marttinen Regulatory Affairs Specialist Lääkärinkatu 2, FIN-33520 Tampere, FINLAND

Re: K071464 Trade/Device Name: Inion Hexalon™ Biodegradable ACL/PCL Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC, JDR, MAI Dated: May 25, 2007

Received: May 29, 2007

Dear Ms. Marttinen:

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. Kati Marttinen

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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 yours,

Mark A. Miller

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:

K 071464

Device Name:

Inion Hexalon™ Biodegradable ACL/PCL Screw

Indications for use:

The Inion Hexalon™ Biodegradable ACL/PCL Screw is intended for soft tissue (including ligament, tendon, and bone-tendon-bone graft) fixation to bone in surgeries of the knee, shoulder, elbow, ankle, tendon, and other that offered screw sizes are patient appropriate.

Prescription Use X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Murk A. Milham

(Division Sign-Of eral Restorative. Division of Gen and Neurologi

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510(k) Number _

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.