A. General indications: These INION OTPS™ BIODEGRADABLE FIXATION SYSTEM issuplants are generally intended for maintenance of reduction of cancellous bone fractures, osteotomies or arthrodeses of the upper extremity, ankle and foot in the presence of appropriate brace and/or immobilization.

B. Specific indications:

Fractures and osteotomies of the malleoli
Ankle fractures

Device Description

The modified Inion OTPS™ Biodegradable Fixation system implants are identical to the currently cleared devices except for the modifications which have been detailed in section 3 of this submission.

Inion OTPS™ Biodegradable Fixation System implants are made of resorbable polylactic acid / trimethylenecarbonate copolymers. Inion O'EPS™ 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

This document is a 510(k) summary for a modification to an existing biodegradable fixation system. It confirms the device's substantial equivalence to a predicate device and does not involve AI or a clinical study to establish acceptance criteria or device performance in the way described in your request. Therefore, I cannot provide the detailed information about acceptance criteria, study design, and AI performance from this document.

The document indicates:

The device is a modified Inion OTPS™ Biodegradable Fixation System.
The modification makes the implants identical to currently cleared devices except for the modifications detailed in section 3 (which is not provided in the extracted text).
The manufacturer is asserting substantial equivalence to their predicate device (K030900) based on performance data and specifications.
No applicable mandatory performance standards exist, but compliance to voluntary consensus standards is listed in the application (details not provided).
The FDA has reviewed the submission and found the device substantially equivalent.

No information regarding AI, acceptance criteria, or clinical study data is present in these sections of the 510(k) summary.

Summary

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Image /page/0/Picture/0 description: The image shows a logo with the word "MOON" in large, bold, white letters. Below the word "MOON" is the phrase "Intelligent Solution" in a smaller, italicized font. The background is split vertically, with the left side appearing lighter and textured, while the right side is darker and more solid.

K062617

SPECIAL 510(k) SUMMARY for the modification to Inion OTPS™ Biodegradable Fixation Systern (K030900)

OCT = 4 2006

MANUFACTURER

Inion Oy, Lääkärinkatu 2, FIN-33520 Tampere, FINLAND

Contact Person

Kati Marttinen, Regulatory Affairs Specialist Lääkärinkatu 2, FIN-33520 Tampere Phone: +358 3 2306 600 Fax: +358 3 2306 691 kati.marttinen@inion.com

DEVICE NAME

Trade name: Inion OTPS™ Biodegradable Fixation System Common/Usual Name: Biodegradable bone 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 'sone fixation fastener Regulatory Class: Class II Product Code: HWC

PREDICATE DEVICE

Inion OTPS™ Biodegradable Fixation System (K030900)

CONFORMANCE WITH PERFORMANCE STANDARDS

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

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Image /page/1/Picture/1 description: The image shows a logo with the letters "ON" in a bold, sans-serif font. Below the letters, there is the text "Intelligent Solution" in a smaller, lighter font. The background is a mix of black and white, with a grainy texture that gives the image a slightly distressed look. The logo and text are white, contrasting with the darker background.

DEVICE DESCRIPTION AND PRINCIPLES OF OPERATION

The modified Inion OTPS™ Biodegradable Fixation system implants are identical to the currently cleared devices except for the modifications which have been detailed in section 3 of this submission.

Indications

Inion OTPS™ Biodegradable Fixation system screws are 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 ເ
Ankle fractures

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, degradation profile and mechanical properties of the modified Inion OTPS™ Biodegradable Fixation system screws are substantially equivalent with the predicate device Inion OTPSTM Biodegradable Fixation system (K030900).

The modified Inion OTPS™ Biodegradable Fixation system screws are substantially equivalent to predicate Class II devices used 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, because the differences between the modified Inion OTPSTM Biodegradable Fixation system 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 seal of the Department of Health and Human Services (HHS) of the United States. The seal features the department's name in a circular arrangement around a stylized emblem. The emblem consists of a stylized caduceus, a symbol often associated with healthcare, with three parallel lines forming the wings and a snake winding around a staff.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT = 4 2006

Inion Ltd c/o Ms. Kati Marttinen Regulatory Affairs Specialist Lääkärinkatu 2. FIN-33520 Tampere, Finland

Re: K062617

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: Class II Product Code: HWC Dated: August 31, 2006 Received: September 5, 2006

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). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance artits toll=free™ator (2007-638-2011 cr 240-276-3150 or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html.

Sincerely yours.

Sincerely, yours,

Jubara mucttr

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: K062617

Device Name: Inion OTPS™ Biodegradable Fixation System

Indications:

B. Specific indications:

Fractures and osteotomies of the malleoli ●
. Ankle fractures

Contraindications:

These INION OTPS™ BIODEGRADABLE FIXATION SYSTEM implants are not intended for use in and are 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).

· High-load bearing applications.

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 NEEDEL)

Concurrence of CDRH, Office of Device Evaluation (ODE)

chabara buchn

(Division Sign-Of Division of General, Restorative, and is curological Devices

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510(k) Number K062617

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.