INION OTPS BIODEGRADABLE MINI PLATING SYSTEM

K023887 · Inion , Ltd. · HWC · May 30, 2003 · Orthopedic

Device Facts

• Record ID: K023887
• Device Name: INION OTPS BIODEGRADABLE MINI PLATING SYSTEM
• Applicant: Inion , Ltd.
• Product Code: HWC · Orthopedic
• Decision Date: May 30, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Inion OTPS™ Biodegradable Mini Plating System is intended for use in fixation of noncomminuted diaphyseal fractures of the metacarpal, proximal phalangeal, middle phalangeal and osteotomies in the presence of appropriate immobilization.

Device Story

Inion OTPS™ Biodegradable Mini Plating System consists of resorbable plates and screws for fixation of metacarpal and phalangeal fractures. Implants are composed of polylactic acid/trimethylenecarbonate copolymers. Device provides temporary fixation during healing; implants gradually lose strength over 18-36 weeks, with complete resorption within 2-4 years. Used by surgeons in clinical settings; requires appropriate immobilization. Benefits include elimination of secondary surgery for implant removal due to biodegradable nature. Mechanical performance is comparable to metallic and other biodegradable fixation systems.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Biodegradable bone plating system. Materials: Poly(L-lactide-co-D,L-lactide) and poly(L-lactide-co-trimethylenecarbonate) copolymers. Resorbable. Strength retention 18-36 weeks; complete resorption 2-4 years. Form factor: Plates and screws for hand/phalangeal fixation.

Indications for Use

Indicated for fixation of noncomminuted diaphyseal fractures of the metacarpal, proximal phalangeal, and middle phalangeal bones and osteotomies. Contraindicated in patients with active/potential infection, limited blood supply, insufficient bone quality/quantity, lack of patient cooperation (e.g., alcoholism, drug abuse), and load-bearing procedures.

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

• ReUnite Bone Screw (K992301)
• LactoSorb Hand System (K991763)
• Synthes Compact Hand 1.0/1.3 (pre-amendment device)

Submission Summary (Full Text)

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MAY 3 0 2003

Ko13887

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510(k) SUMMARY Inion OTPS™ Biodegradable Mini Plating System

MANUFACTURER Inion Ltd. Lääkärinkatu 2 FIN-33520 Tampere

Contact Person: Hanna Marttila Regulatory Affairs Manager Phone: [phone] Fax: [phone] [e-mail]

#### DEVICE NAME

Trade name: Inion OTPS™ Biodegradable Mini Plating System Common/Usual Name: Bone Plating System Classification Name: Bone Plate, 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 (screw) 21 CFR 888.3030 - Single multiple component metallic bone fixation appliances and accessories, 87 HRS (plate)

## PREDICATE DEVICES

(1) Biomet Inc .; ReUnite Bone Screw (K992301) (2) Biomet Inc .; LactoSorb Hand System (K991763) (3) Syntehes(USA); Synthes Compact Hand 1.0/1.3 (pre-amendment device)

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#### DEVICE DESCRIPTION AND PRINCIPLES OF OPERATION

The Inion OTPS™ Biodegradable Mini Plating System is intended for use in fixation of non-comminuted diaphyseal fractures of the metacarpal, proximal phalangeal, middle phalangeal and osteotomies in the presence of appropriate immobilization.

The Inion OTPS™ Biodegradable Mini Plating System is consisted of biodegradable screws and plates intended to be used in fractures of phalanges and metacarpal. Implants will be utilized by using common surgical techniques. The Inion OTPS™ Biodegradable Mini Plating System is made of resorbable polylactic acid / trimethylenecarbonate copolymers [Poly (L-lactide-co-D,L-lactide) and poly (L-lactide-co-trimethylenecarbonate)). The Inion OTPS™ Biodegradable Mini Plating 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 Mini Plating System is substantially equivalent to biodegradable implants, intended for metacarpal and phalangeal fracture fixation procedures, which have received 510(k) clearance. Inion OTPS™ Biodegradable Mini Plating System LactoSorb Hand System (K991763) and ReUnite Screw (K992301) 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. The differences between the Inion OTPS™ Biodegradable Mini Plating System and predicate devices do not raise 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" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with three stylized lines representing its wings or body.

Public Health Service

MAY 3 0 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: K023887

Trade/Device Name: Inion OTPS™ Biodegradable Mini Plating System Regulation Number: 21 CFR 888.3040 and 888.3030 Regulation Name: Smooth or threaded metallic bone fixation fastener, and Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HWC and HRS Dated: March 4, 2003 Received: March 6, 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.

sincerely yours,

L. Mark A. Mellekerson

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 OTPS™ Biodegradable Mini Plating System

#### Indications:

The Inion OTPS™ Biodegradable Mini Plating System is intended for use in fixation of noncomminuted diaphyseal fractures of the metacarpal, proximal phalangeal, middle phalangeal and osteotomies in the presence of appropriate immobilization.

#### Contraindications:

Inion OTPS™ Biodegradable Mini Plating 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. Load bearing procedures.

ﺴﻴﺴﺎ

| Prescription use | <i>Yes</i> |
|----------------------|------------|
| Over the Counter use | <i>No</i> |

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Per 21 CFR 801.109)

(Division Sign-Off)

Division of General, Restorative
and Neurological Devices

| Date: | 15 |
|---------|----|
| Status: | F |

KO 2388

510(k) Number_

5.11.2002 Status: Final