The Inion OTPS Biodegradable Fixation System is generally intended for maintenance of reduction and fixation of cancellous bone fractures, osteotomies or arthrodeses of the upper extremity, ankle and foot in the presence of appropriate brace and/or immobilization.

Specific indications:

Fractures and osteotomies of the malleoli .
Ankle fractures

Device Description

The Inion OTPS™ Biodegradable Fixation System is made of resorbable polylactic acid / trimethylenecarbonate copolymers [Poly (L-lactide-co-D,L-lactide) and poly (L-lactide-cotrimethylenecarbonate)]. The Inion OTPS™ Biodegradable Fixation System implants gradually lose their strength during 18-36 weeks in vivo with complete strength loss and resorption within two to four years.

AI/ML Overview

The provided text describes a medical device, the Inion OTPS™ Biodegradable Fixation System, and its regulatory clearance. However, it does not include information about acceptance criteria or a study that specifically proves the device meets such criteria in terms of performance in a clinical or diagnostic setting.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices through mechanical testing and shared intended use, which is a common path for 510(k) clearances. This means that instead of new clinical performance studies, the clearance relies on the established safety and effectiveness of similar, already marketed devices.

Therefore, I cannot provide the requested information. The text does not contain:

A table of acceptance criteria and reported device performance.
Sample size, data provenance, number of experts, qualifications of experts, or adjudication method for a test set.
Information on a multi-reader multi-case (MRMC) comparative effectiveness study or related effect sizes.
Data on standalone device performance in a diagnostic context.
Details on the type of ground truth used for performance validation.
Sample size for a training set or how ground truth for a training set was established, as this would typically apply to AI/software performance studies, which is not the nature of this device's clearance.

The "study" mentioned is general "mechanical testing" to demonstrate substantial equivalence, not a clinical performance study with specific acceptance criteria and ground truth.

Summary

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Ko3o900 page 1 of 2

UNION
elligent Solution

510(k) SUMMARY for the Inion OTPS™ Biodegradable Fixation System

JUN 1 9 2003

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 OTPS™ Biodegradable Fixation System 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

(1) Bionx Inc .; SmartScrew (K012001, K003077) (2) Biomet Bone Screw (K964970)

Date:20.3.2003 Status: Final

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Page 2 of 2

DEVICE DESCRIPTION AND PRINCIPLES OF OPERATION

The Inion OTPS™ Biodegradable Fixation System is generally intended for maintenance of reduction and fixation of cancellous bone fractures, osteotomies or arthrodeses of the upper extremity, ankle and foot in the presence of appropriate brace and/or immobilization.

EQUIVALENCE TO MARKETED PRODUCTS

The Inion OTPS™ Biodegradable Fixation System is substantially equivalent to biodegradable implants, intended for similar indications, which have received 510(k) clearance. Inion OTPS™ Biodegradable Fixation System implants, Bionx Inc. SmartScrew (K012001, K003077) and Biomet Bone Screw (K964970) 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 ones. Differences between the Inion OTPS™ Biodegradable Fixation System and predicate devices do not raise any 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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract human profiles facing to the right, with lines suggesting movement or connection between them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 9 2003

Ms. Hanna Marttila Regulatory Affairs Manager Inion Ltd. Lääkärinkatu 2 Fin-33520 Tampere Finland

Re: K030900

Trade/Device Name: Inion OTPS™ Biodegradable Fixation System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: March 19, 2003 Received: March 24, 2003

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 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 (301) 594-4639. 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 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.

L. Mark N. Wilkerson

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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D STATEMENT OF INDICATIONS FOR USE

Applicant: Inion Ltd 510(k) Number: Device Name: Inion Biodegradable Fixation System

Indications:

Specific indications:

Fractures and osteotomies of the malleoli .
Ankle fractures

Contraindications:

The OTPS Biodegradable Fixation System is not intended for use in and is contraindicated for:

Active or potential infection
Patient conditions including limited blood supply, insufficient quantity or quality of bone; and where patient cooperation cannot be guaranteed. (e.g., alcoholism, drug abuse) 3. High load bearing applications

Prescription use __ Over the Counter use

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Per 21 CFR 801.109)

Mark A. Melkerson

(Division Sign-Off) Division of General, Restorative and Neurological Devices

K 030906 510(k) Number _

Date: 19.3.2003 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.