MODIFICATION TO INION OTPS BIODEGRADABLE FIXATION SYSTEM

K062617 · Inion , Ltd. · HWC · Oct 4, 2006 · Orthopedic

Device Facts

• Record ID: K062617
• Device Name: MODIFICATION TO INION OTPS BIODEGRADABLE FIXATION SYSTEM
• Applicant: Inion , Ltd.
• Product Code: HWC · Orthopedic
• Decision Date: Oct 4, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

These INION OTPS™ BIODEGRADABLE FIXATION SYSTEM implants 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. Specific indications: - Fractures and osteotomies of the malleoli - Ankle fractures

Device Story

Inion OTPS™ Biodegradable Fixation System consists of resorbable bone screws made of polylactic acid/trimethylenecarbonate copolymers. Used by surgeons for internal fixation of cancellous bone fractures, osteotomies, or arthrodeses in the upper extremity, ankle, and foot. Implants provide temporary mechanical stability for bone healing; strength gradually decreases over 18-36 weeks in vivo, with complete resorption occurring within two to four years. Device requires concurrent use of external bracing or immobilization. Benefits include elimination of secondary surgery for hardware removal due to biodegradable nature.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by performance data and specifications demonstrating that the modified device maintains the same mechanical properties and degradation profile as the predicate.

Technological Characteristics

Resorbable bone screws composed of polylactic acid/trimethylenecarbonate copolymers. Mechanical strength loss occurs over 18-36 weeks; complete resorption within 2-4 years. Class II device (21 CFR 888.3040).

Indications for Use

Indicated for maintenance of reduction of cancellous bone fractures, osteotomies, or arthrodeses of the upper extremity, ankle, and foot, specifically malleoli fractures/osteotomies and ankle fractures. Contraindicated in patients with active/potential infection, limited blood supply, insufficient bone quality/quantity, inability to cooperate (e.g., drug/alcohol 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

• Inion OTPS™ Biodegradable Fixation System (K030900)

Submission Summary (Full Text)

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

### 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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## 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.

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.

#### 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 [phone]. 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:

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

#### 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