INION CPS/OTPS FREEDOMPLATE

K063410 · Inion , Ltd. · HRS · Jan 23, 2007 · Orthopedic

Device Facts

• Record ID: K063410
• Device Name: INION CPS/OTPS FREEDOMPLATE
• Applicant: Inion , Ltd.
• Product Code: HRS · Orthopedic
• Decision Date: Jan 23, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

A. General indications: In the presence of appropriate additional immobilization or fixation, indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodeses or bone grafts, and maintenance of relative position of weak bony tissue (e.g., bone grafts, bone graft substitutes, or bone fragments from comminuted fractures), in trauma and reconstructive procedures, and cement restriction in total joint arthroplasty procedures. B. Specific indications: 1. Craniofacial skeleton, cranium, mid-face, maxilla, and mandible 2. Metacarpus, proximal and middle phalangeal bones 3. Long bones, flat bones, short bones, irregular bones, appendicular skeleton, and thorax

Device Story

Inion CPS/OTPS FreedomPlate™ is a bioabsorbable bone fixation system; composed of polylactic acid/trimethylenecarbonate copolymers. Used by surgeons in clinical settings for maintenance of alignment/fixation of bone fractures, osteotomies, arthrodeses, bone grafts, and cement restriction in joint arthroplasty. Implants provide temporary mechanical support; strength loss occurs over 18-36 weeks; complete bioresorption within 2-4 years. Provided sterile; intended for use with additional immobilization/fixation.

Clinical Evidence

No clinical data provided; substantial equivalence based on performance data and specifications.

Technological Characteristics

Resorbable polylactic acid / trimethylenecarbonate copolymers. Sterile, bioabsorbable fixation plates. Strength retention 18-36 weeks; resorption 2-4 years. No mandatory performance standards; conforms to voluntary consensus standards.

Indications for Use

Indicated for patients requiring bone fixation or alignment maintenance in trauma and reconstructive procedures, including craniofacial, metacarpal, phalangeal, and appendicular skeletal sites. Requires additional immobilization or fixation.

Regulatory Classification

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.

Predicate Devices

• Inion® CPS™ 1.5/2.0/2.5 Bioabsorbable Fixation System (K010352)
• Inion® OTPS™ Biodegradable Mini Plating System (K023887)
• Inion® OTPS™ Biodegradable Mesh Plating System (K031961)

Submission Summary (Full Text)

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K063410 pg 42

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## Inion® CPS/OTPS FreedomPlate™

JAN 2 3 2007

#### Indications for use

A. General indications: In the presence o appropriate additional immobilization or fixation, indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodeses or bone grafts, and maintenance of relative position of weak bony tissue (e.g., bone grafts, bone graft substitutes, or bone fragments from comminuted fractures), in trauma and reconstructive procedures, and cement restriction in total joint arthroplasty procedures.

- B. Specific indications:
- 1. Craniofacial skeleton, cranium, mid-face, maxilla, and mandible
- 2. Metacarpus, proximal and middle phalangeal bones
- 3. Long bones, flat bones, short bones, irregular bones, appendicular skeleton, and thorax

#### 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 CPS/OTPS FreedomPlate™ are substantially equivalent with the predicate devices Inion® CPS™ 1.5/2.0/2.5 Bioabsorbable Fixation System (K010352), Inion® OTPS™ Biodegradable "Mini Plating System (K023887) and Inion® OTPS™ Biodegradable Mesh Plating System (K031961).

Inion CPS/OTPS FreedomPlate™ is sulvstantially equivalent to predicate Class II devices, when used, in the presence of appropriate additional immobilization or fixation. for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodeses or bone grafts, and maintenance of relative position of weak bony tissue (e.g., bone grafts, bone graft substitutes, or bone fragments from comminuted fractures), in trauma and reconstructive procedures, and cement restriction in total joint arthroplasty procedures, because the differences between Inion CPS/OTPS FreedomPlate™ and the predicate devices do not raise new questions of safety and effectiveness.

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## 510(k) SUMMARY

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Inion® CPS/OTPS FreedomPlate™

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Manufacturer and submitter Inion Oy, Lääkärinkatu 2, FIN-33520 Tampere, FINLAND

### Contact Person

Kati Marttinen, Regulatory Affairs Specialist Phone: [phone] Fax: [phone] [e-mail]

Establishment registration number 9710629

Trade name of the device Inion® CPS/OTPS FreedomPlate™

## Device classification and product code

Class II Classification Panel: Orthopedic Product Code: HRS Common name: Plate, fixation, bone Regulation number: 21 CFR 888.3030

### Predicate devices

Inion® CPS™ 1.5/2.0/2.5 Bioabsorbable Fixation System (K010352) Inion® OTPS™ Biodegradable Mini Plating System (K023887) Inion® OTPS™ Biodegradable Mesh Plating System (K031961)

### Conformance with performance standards

No applicable mandatory performance standards exist for this device. Compliance to voluntary consensus standards is listed in the application.

## Device description and principles of operation

Inion CPS/OTPS FreedomPlate™ implants are made of resorbable polylactic acid / trimethylenecarbonate copolymers and they are provided in sizes typical to this application. Inion CPS/OTPS FreedomPlate 1.5 implants gradually lose their strength during 18-36 weeks in vivo. Bioresorption takes place within two to four years.

Inion CPS/OTPS FreedomPlate™ implants are provided sterile to the user. The shelf life of the device is 3 years.

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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 stylized eagle with three bars representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The text is in all capital letters and is in a sans-serif font.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Inion Oy % Ms. Kati Marttinen Regulatory Affairs Specialist Lija akiarinkatu 2 33520 Tampere, FINLAND

JAN 2 3 2007

Re: K063410 Trade/Device Name: Inion® CPS/OTPS Freedom Plate™ Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS Dated: November 10, 2006 Received: November 13, 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" (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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson
Director

1/22/07

Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Statement of Indications for Use

510(k) Number:

Ko63410

Device Name:

Inion® CPS/OTPS Freedor::Plate™

## INDICATIONS

A. General indications: In the presence of appropriate additional immobilization or fixation, indicated for maintenance of alignment and fixation of bone fractures, arthrodeses or bone grafts, and maintenance of relative position of weak bony tissue (e.g., bone graft substitutes, or bone fragments from comminuted fractures), in trauma and reconstructive procedures, and cement restriction in total joint arthroplasty procedures.

B. Specific indications:

- 1. Craniofacial skeleton, cranium, mid-face, maxilla, and mandible
- 2. Metacarpus, proximal and middle phalangeal bones
- 3. Long bones, flat bones, short bones, irregular bones, appendicular skeleton, and thorax

| Prescription Use<br>(Part 21 CFR 801 Subpart D) | <b>X</b> |
|-------------------------------------------------|----------|
|-------------------------------------------------|----------|

AND/OR

| Over-The-Counter Use<br>(21 CFR 801 Subpart C) | |
|------------------------------------------------|--|
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

(Division Sign-Off)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of General, Restorative,
and Neurological Devices

| 510(k) Number | LC63410 |
|---------------|---------|
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