INION SPINAL GRAFT CONTAINMENT SYSTEM

K071810 · Inion , Ltd. · OJB · Jul 11, 2008 · Orthopedic

Device Facts

• Record ID: K071810
• Device Name: INION SPINAL GRAFT CONTAINMENT SYSTEM
• Applicant: Inion , Ltd.
• Product Code: OJB · Orthopedic
• Decision Date: Jul 11, 2008
• Decision: SESU
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Inion Spinal Graft Containment System, in conjunction with traditional rigid fixation, is intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts or autografts. The device is not intended for load bearing indications.

Device Story

Inion Spinal Graft Containment System consists of plates, meshes, and screws composed of degradable polylactic acid copolymers (P(L/DL)LA). Implants include tantalum spheres for postoperative radiographic imaging. Device used by surgeons in spinal fusion procedures to contain bone graft material; must be used as an adjunct to traditional rigid fixation. Implants retain strength for 16 weeks; bioresorption occurs over 2-4 years. Provides containment of weak bony tissue; prevents graft migration. Not designed for load-bearing; requires supplemental rigid fixation to maintain spinal stability.

Clinical Evidence

Bench testing only. In vitro data demonstrates implant strength retention for 16 weeks and bioresorption within two to four years.

Technological Characteristics

Materials: degradable polylactic acid copolymers (P(L/DL)LA). Components: plates, meshes, screws. Radiographic markers: tantalum spheres. Sterilization: provided sterile. Shelf life: 3 years. Non-collagenous.

Indications for Use

Indicated for use in spinal fusion procedures in patients requiring maintenance of relative position of weak bony tissue (allografts or autografts). Must be used with traditional rigid fixation. Not for load-bearing indications.

Regulatory Classification

Identification

A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.

Predicate Devices

• Macropore OS SpineTM System (K010911)
• MacroPore HydrosorbTM Spine System (K041105)
• Inion S-1 1M Biodegradable Anterior Cervical Fusion System (K051821)
• Biomet Tantalum Beads - Radiographic Marker (K010348)

Submission Summary (Full Text)

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# 510(k) SUMMARY

Image /page/0/Picture/1 description: The image shows the word "INION" in large, bold, white letters against a green background. Below the word "INION" is the phrase "Intelligent Solution" in a smaller, sans-serif font, also in white. The overall design is simple and clean, with a focus on the company name and its tagline.

Inion Spinal Graft Containment System

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 Spinal Graft Containment System

## Device classification and product code

Class II Classification Panel: Orthopedic Product Code: KWQ Common name: Appliance, fixation, spinal intervertebral body Regulation number: 21 CFR 888.3060

#### Predicate devices

Macropore OS SpineTM System (K010911) MacroPore HydrosorbTM Spine System (K041105) Inion S-1 1M Biodegradable Anterior Cervical Fusion System (K051821) Biomet Tantalum Beads - Radiographic Marker (K010348)

#### Device description and principles of operation

Inion Spinal Graft Containment System includes plates, meshes and screws which are made of degradable polylactic acid copolymers, P(L/DL)LA. Based on in vitro data: the implants retain most of their initial strength 16 weeks and gradually lose their strength thereafter. Bioresorption takes place within two to four years. The plates and screws include tantalum spheres for postoperative radiographic imaging.

The implants are offered in different shapes and sizes suitable for this application. Inion Spinal Graft Containment System implants are provided sterile to the user and are noncollagenous. The shelf life of the device is 3 years.

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# 510(k) SUMMARY

Inion Spinal Graft Containment System

Image /page/1/Picture/2 description: The image shows the word "INION" in large, white, sans-serif font against a green background. Below the word "INION" is the phrase "Intelligent Solution" in a smaller, white, sans-serif font. The background is a textured green pattern.

## Indications for use

Inion Spinal Graft Containment System, in conjunction with traditional rigid fixation, is intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts or autografts. The device is not intended for load bearing indications.

## 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 Spinal Graft Containment System are substantially equivalent with the predicate devices Macropore OS Spine™ System (K010911), MacroPore Hydrosorb™ Spine System (K041105) and Inion S-17M Biodegradable Anterior Cervical Fusion System (K051821), and additionally in regard to radiographic marker, with Biomet Tantalum Beads - Radiographic Marker (K010348).

Inion Spinal Graft Containment System is substantially equivalent to predicate Class II devices when used, in conjunction with traditional rigid fixation, in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts or autografts, because the differences between Inion Spinal Graft Containment System and the predicate devices do not raise new questions of safety and effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The eagle is depicted in black, and the text is also in black.

JUL 1 1 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Inion Oy % Ms. Kati Marttinen Regulatory Affairs Specialist Laakarinkatu 2 Tampere Finland 33520

> K071810 Trade/Device Name: Inion Spinal Graft Containment System Regulation Number: 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: OJB Dated: April 21, 2008 Received: April 24, 2008

Dear Ms. Marttinen:

Re:

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). You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. 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.

The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Precautions/Warnings section of the device's labeling:

"The safety and effectiveness of this device, as an adjunct to fusion, when used without rigid supplemental internal fixation has not been established. This device is not designed to withstand physiologic loads when used by itself."

Furthermore, the indication for graft containment use must be prominently displayed in all labeling, including pouch box, and carton labels, instructions for use, and other promotional materials, in close proximity to the trade name, of a similar point size, and in bold print.

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# Page 2 - Ms. Kati Marttinen

Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.

The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification if the limitation statement described above is added to your labeling.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

If you desire specific information about the application of other labeling requirements to your device (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 at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

DaGrell

Donna-Bea Tillman, Ph.D., M.P.A. Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): K071810

Device Name:

Inion Spinal Graft Containment System

Indications For Use:

Inion Spinal Graft Containment System, in conjunction with traditional rigid fixation, is intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts or autografts. The device is not intended for load bearing indications.

Prescription Use V (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

V. Garten

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