INION OTPS BIODEGRADABLE PIN

K031712 · Inion , Ltd. · HTY · Aug 28, 2003 · Orthopedic

Device Facts

• Record ID: K031712
• Device Name: INION OTPS BIODEGRADABLE PIN
• Applicant: Inion , Ltd.
• Product Code: HTY · Orthopedic
• Decision Date: Aug 28, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Inion OTPS™ Biodegradable Pin is indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodeses or bone grafts in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast, brace).

Device Story

Inion OTPS™ Biodegradable Pin is a resorbable bone fixation fastener. Device fabricated from polylactic acid/trimethylenecarbonate copolymers; available in various dimensions and lengths; includes undyed and colored versions for surgical visualization. Used by surgeons in clinical settings to maintain alignment of bone fractures, osteotomies, arthrodeses, or bone grafts. Requires concurrent use of additional immobilization (e.g., rigid fixation, cast, brace). Device provides temporary fixation; gradually loses strength over 18-36 weeks in vivo; undergoes complete resorption within two to four years. Benefits patient by providing necessary stabilization during healing without requiring secondary removal surgery.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Resorbable polylactic acid / trimethylenecarbonate copolymers [Poly (L-lactide-co-D,L-lactide) and poly (L-lactide-cotrimethylenecarbonate)]. Mechanical fixation device. Available in multiple dimensions/lengths. Undyed or colored for visualization. Sterilized for surgical use.

Indications for Use

Indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodeses, or bone grafts requiring additional immobilization. Contraindicated for diaphyseal bone fractures/osteotomies, insufficient bone quality/quantity, active/potential infections, limited blood supply, or patients lacking cooperation (e.g., alcoholism, drug abuse).

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 Implants, Inc.; PLLA Pin (K010983)
• DePuy ACE; OrthoSorb Absorbable Pin (K901456)
• Synthes; Polypin (K961608)

Submission Summary (Full Text)

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AUG 2 8 2003

(03/7/2

Image /page/0/Picture/1 description: The image shows a logo for INION Intelligent Solution. The logo is white text on a black background. The word "INION" is in large, bold letters, and the words "Intelligent Solution" are in smaller letters below it. There is a white line on the left side of the image.

# 510(k) SUMMARY for the Inion OTPS™ Biodegradable Pin

MANUFACTURER Inion Ltd. Lääkärinkatu 2 FIN-33520 Tampere

Contact Person: Har.na Marttila Regulatory Affairs Manager Lääkärinkatu 2 FIN-33520 Tampere Phone: [phone] Fax: [phone] [e-mail]

# DEVICE NAME

Trade name: Inion OTPS™ Biodegradable Pin Common/Usual Name: Pin, Fixation

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

Bionx Implants, Inc .; PLLA Pin (K010983) DePuy ACE; OrthoSorb Absorbable Pin (K901456) Synthes; Polypin (K961608)

> Date: 20.5.2003 Status: Final

Pin

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# DEVICE DESCRIPTION AND PRINCIPLES OF OPERATION

The Inion OTPS™ Biodegradable Pin is indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodeses or bone grafts in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast, brace). Pins are offered in several dimensions and lengths typical for this application.

The Inion OTPS™ Biodegradable Pin is made of resorbable polylactic acid / trimethylenecarbonate copolymers [Poly (L-lactide-co-D,L-lactide) and poly (L-lactide-cotrimethylenecarbonate)]. Pins are offered both undyed and coloured for better visualization during surgical operation. The Inion OTPS™ Biodegradable Pin gradually loses its 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 Pin is substantially equivalent to those of the previously accepted and clinically successfully used biodegradable pins intended for similar indications.

Inion OTPS™ Biodegradable Pin, SmartPin (K010983), OrthoSorb Absorbable Pin (K901456) and Polypin (K961608) have the same 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 Pin and predicate devices do not raise any new questions of safety and effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge of the circle. In the center of the circle is an abstract symbol that resembles an eagle or other bird.

Public Health Service

AUG 2 8 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K031712

Trade/Device Name: Inion OTPS™ Biodegradable Pin Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HTY Dated: May 20, 2003 Received: June 10, 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 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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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,

Sincerely yours,

Mark M. Milken

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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INION LTD.

510(k)

K 03/7/2

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# D STATEMENT OF INDICATIONS FOR USE

Applicant: Inion Ltd. 510(k) Number: Device Name: Inion OTPS™ Biodegradable Pin

Indications:

The Inion OTPSTM Biodegradable Pin is indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodeses or bone grafts in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast, brace).

#### Contraindications:

The Inion OTPS™ Biodegradable Pin should not be used in fractures and osteotomies of diaphyseal bone or in cases with insufficient quality or quantity of bone. Other contraindications are active or potential infections, patient conditions including limited blood supply, and where patient cooperation cannot be guaranteed (e.g. alcoholism, drug abuse).

| Prescription use | |
|----------------------|----|
| Over the Counter use | No |

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Per 21 CFR 801.109)

*for*

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

| 510(k) Number | K031712 |
|---------------|---------|
| Pin | |
| Date: 20.5.20 | |

te: 20.5.2003 Status: Final