The INION OTPS™ BIODEGRADABLE DISTAL RADIUS PLATE implants are indicated for use in open reduction and internal fixation of fractures, and radiolunocarpal fusion of the distal radius in the presence of appropriate immobilization.

Device Description

Inion OTPS™ Biodegradable Distal Radius Plate implants are indicated for use in open reduction and internal fixation of fractures, osteotomies, and radiolunocarpal fusion of the distal radius in the presence of appropriate immobilization. Inion OTPS 100 Biodegradable Distal Radius Plate implants are made of is made of resorbable polylactic acid / trimethylenecarbonate copolymers and it is provided in sizes typical to this application.

Inion OTPS™ Biodegradable Distal Radius Plate implants gradually lose their strength during 18-36 weeks. Bioresorption takes place within two to four years.

Inion OTPS™ Biodegradable Distal Radius Plate implants are provided sterile to the user and is non-pyrogenic. The shelf life of the device is 3 years.

AI/ML Overview

The provided document is a 510(k) summary for the Inion OTPS™ Biodegradable Distal Radius Plate. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain any information about a study that establishes acceptance criteria for device performance or provides reported device performance data, especially in the context of AI/ML software.

The document discusses the mechanical properties and degradation profile of the Inion OTPS™ plate in relation to a predicate metallic device, but this is a comparison based on product specifications and potentially bench testing, not a clinical study involving specific acceptance criteria for performance metrics like accuracy, sensitivity, or specificity.

Therefore, I cannot fulfill your request for the detailed table and study information as it is not present in the provided text.

The 510(k) process for medical devices like this typically focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials to establish and meet specific performance acceptance criteria for a novel AI/ML application. The performance here refers to the physical properties and functional equivalence of the biodegradable plate to a metallic plate, not the diagnostic or predictive accuracy of a software.

Summary

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K05-2624

Image /page/0/Picture/2 description: The image shows a logo with the word "INION" in large, bold letters. Below the word "INION" is the phrase "Intelligent Solution" in a smaller font. The background is black, and the text is white, creating a high contrast. There is also a white circle at the bottom of the image.

NOV 1 6 2005

510(k) SUMMARY for Inion OTPS™ Biodegradable Distal Radius Plate

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 OTPSTM Biodegradable Distal Radius Plate

ESTABLISHMENT REGISTRATION NUMBER 9710629

DEVICE CLASSIFICATION AND PRODUCT CODE

Class : II Classification Panel: Orthopedic Product Code: HRS

Common name: Plate, fixation, bone Regulation number: 21 CFR 888.3030 Regulation name: Single/multiple component metallic bone fixation appliances and accessories.

PREDICATE DEVICE

Biomet Distal Radius Plating System K020819

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 the word "INION" in large, bold, white letters against a black background. Below "INION" are the words "Intelligent Solution" in a smaller, italicized font. The logo appears to be for a company or product named INION, emphasizing its focus on providing intelligent solutions.

DEVICE DESCRIPTION AND PRINCIPLES OF OPERATION

Inion OTPS™ Biodegradable Distal Radius Plate implants gradually lose their strength during 18-36 weeks. Bioresorption takes place within two to four years.

Inion OTPS™ Biodegradable Distal Radius Plate implants are provided sterile to the user and is non-pyrogenic. The shelf life of the device is 3 years.

SUBSTANTIAL 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 Inion OTPSTM Biodegradable Distal Radius Plate are substantially equivalent with the predicate device Biomet Distal Radius Plating System (K020819).

Inion OTPS™ Biodegradable Distal Radius Plate is substantially equivalent to predicate Class II devices used in open reduction and internal fixation of fractures, osteotomies, and radiolunocarpal fusion of the distal radius in the presence of appropriate immobilization, because the differences between Inion OTPSTM Biodegradable Distal Radius Plate 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 a circular design with the department's name encircling the perimeter. Inside the circle is a stylized representation of three human profiles facing right, symbolizing health and human services. The seal is in black and white.

NOV 1 6 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K052624

Trade/Device Name: Inion OTPS " Biodegradable Distal Radius Plate Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: September 21, 2005 Received: September 23, 2005

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. Ilsting 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- 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), 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/industry/support/index.html.

Sincerely yours,

.
Mark N. Melkerson

Car 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 (if known): Ko (- La 4- La 4-

Inion OTPSTM Biodegradable Distal Radius Plate Device Name:

INDICATIONS

CONTRAINDICATIONS

The INION OTPS™ BIODEGRADABLE DISTAL RADIUS PLATE 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.
· Severely comminuted fractures.

Prescription Use V (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (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)

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

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510(k) Number_ |(05 2624

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.