INION OTPS BIODEGRADABLE FIXATON SYSTEM

K030900 · Inion , Ltd. · HWC · Jun 19, 2003 · Orthopedic

Device Facts

• Record ID: K030900
• Device Name: INION OTPS BIODEGRADABLE FIXATON SYSTEM
• Applicant: Inion , Ltd.
• Product Code: HWC · Orthopedic
• Decision Date: Jun 19, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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.

Device Story

Inion OTPS Biodegradable Fixation System consists of resorbable bone fixation screws. Implants are manufactured from polylactic acid / trimethylenecarbonate copolymers. Device provides temporary fixation for cancellous bone fractures, osteotomies, or arthrodeses in upper extremities, ankles, and feet. Implants maintain reduction while gradually losing strength over 18-36 weeks in vivo, with complete resorption occurring within two to four years. Used by surgeons in clinical settings; requires concurrent use of braces or immobilization. Benefit includes elimination of need for secondary removal surgery due to biodegradable nature of materials.

Clinical Evidence

Bench testing only.

Technological Characteristics

Resorbable polylactic acid / trimethylenecarbonate copolymers [Poly (L-lactide-co-D,L-lactide) and poly (L-lactide-cotrimethylenecarbonate)]. Mechanical fixation via threaded screw design. Biodegradable material properties allow for gradual strength loss over 18-36 weeks and full resorption in 2-4 years.

Indications for Use

Indicated for maintenance of reduction and fixation of cancellous bone fractures, osteotomies, or arthrodeses of the upper extremity, ankle, and foot, including malleoli and ankle fractures. Contraindicated in patients with active/potential infection, limited blood supply, insufficient bone quality/quantity, lack of patient cooperation (e.g., alcoholism, drug abuse), or for high load-bearing applications.

Regulatory Classification

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.

Predicate Devices

• Bionx Inc. SmartScrew (K012001, K003077)
• Biomet Bone Screw (K964970)

Submission Summary (Full Text)

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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: [phone] Fax: [phone] [e-mail]

## 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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## 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.

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.

## 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 [phone]. 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 [phone] or [phone] 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:

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

#### Contraindications:

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

1. Active or potential infection

2. 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