Inion Spinal Graft Containment System

K151360 · Inion OY · OJB · Oct 6, 2015 · Orthopedic

Device Facts

• Record ID: K151360
• Device Name: Inion Spinal Graft Containment System
• Applicant: Inion OY
• Product Code: OJB · Orthopedic
• Decision Date: Oct 6, 2015
• Decision: SESU
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Inion spinal graft containment plate 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. This device is not intended for load bearing indications.

Device Story

Bioresorbable graft containment plate system; used as adjunct to rigid spinal fixation; maintains position of bone graft (allograft/autograft) during fusion. Device consists of poly(L-lactide-co-D,L-lactide 80:20) plates; fixed with screws. Not designed for load-bearing; requires supplemental rigid fixation. Used by surgeons in spinal fusion procedures. Implants are sterile, single-use; degrade over 2-4 years. Line extension adds smaller plate dimensions (15mm width; 31-40mm height) with 2-screw fixation. Benefits patient by containing graft material to facilitate fusion; does not replace healthy tissue.

Clinical Evidence

Bench testing only. Mechanical testing (graft push-off, torsion, axial tensile, axial compression, cyclic compressive bending) and simulated clinical use testing performed to verify strength, fixation, and handling. No clinical data provided.

Technological Characteristics

Material: poly(L-lactide-co-D,L-lactide 80:20). Bioresorbable; non-collagenous. Dimensions: 15mm width, 31-40mm height, 3.2mm thickness. Fixation: 2-screw configuration. Sterile, single-use. Accessory instruments: stainless steel/titanium, reusable, steam-sterilized by user.

Indications for Use

Indicated for use in spinal fusion procedures as an adjunct to traditional rigid fixation to maintain the relative position of weak bony tissue (allografts or autografts). 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

• Inion Spinal Graft Containment System (K071810)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/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" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, layered on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 6, 2015

Inion Oy % Ms. Kati Marttinen Quality and Regulatory Director Lääkärinkatu 2 Tampere, 33520 FINLAND

Re: K151360

Trade/Device Name: Inion Spinal Graft Containment System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: OJB Dated: August 20, 2015 Received: September 2, 2015

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 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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/Contraindications section of the device's labeling:

{1}------------------------------------------------

"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 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.

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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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 advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

{2}------------------------------------------------

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# William H. Maisel - S

William H. Maisel, MD, MPH Director (Acting) Office of Device Evaluation Deputy Center Director for Science Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known)

K151360

Device Name

Inion Spinal Graft Containment System

Type of Use (Select one or both, as applicable)

Indications for Use (Describe)

The Inion spinal graft containment plate 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. This device is not intended for load bearing indications.

| 区 Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
| This section applies only to requirements of the Paperwork Reduction Act of 1995. | |
| *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* | |
| The burden time for this collection of information is estimated to average 79 hours per response, including the<br>iima ta rayiayinana, anarak ayakina dala nauyena, acibar and maintain ina data naadaa ana aamalata, | |

time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{4}------------------------------------------------

510(k) SUMMARY Inion Spinal Graft Containment System

| Manufacturer and submitter: | Inion Oy,<br>Lääkärinkatu 2,<br>FIN-33520 Tampere, FINLAND |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Date | August 20, 2015 |
| Contact person | Kati Marttinen, Quality and Regulatory Director<br>Phone: [phone]<br>Fax: [phone]<br>[e-mail] |
| Establishment registration number | 9710629 |
| Trade name of the device | Inion Spinal Graft Containment System |
| Device classification | Class II |
| Product code | OJB |
| Review panel | Orthopedic |
| Common name | Graft containment plate |
| Classification name | Spinal intervertebral body fixation orthosis |
| Regulation number | 888.3060 |
| Predicate device | Inion Spinal Graft Containment System (K071810) |
| Conformance with performance standards | Compliance to voluntary consensus standards is listed in the application. |

#### Device description and principles of operation

INION S-2™ Biodegradable Anterior Thoraco-Lumbar Fusion System plates are bioresorbable anterior thoraco-lumbar fusion devices for graft containment (screws and plates). The plates are made of degradable poly(L-lactide-co-D,L-lactide 80:20). 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 implants are provided sterile to the user and are non-collagenous. The shelf life of the device is 3 years.

INION S-2™ Biodegradable Anterior Thoraco-Lumbar Fusion System devices provide fixation and are not intended to replace healthy tissues or withstand the stress of full load bearing.

The purpose of this submission is a line extension for new sizes.

{5}------------------------------------------------

# 510(k) SUMMARY Inion Spinal Graft Containment System

### Indications for use

The Inion Spinal Graft Containment plate 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. This device is not intended for load bearing indications.

### Similarities to predicate device

In comparison to predicate device, the new plates have the same indications for use, material composition, manufacturing steps, sterilization method, packaging, shelf life and degradation profile. The new plates are inserted using the predicate device Inion S-2™ system screws unmodified, and same accessory instrumentation.

### Differences to predicate device

In comparison to predicate device, the new plates have different dimensions. Width is 15 mm (predicate device 28 - 120 mm). Height range is 31-40 mm (predicate device 37 - 80 mm). Thickness is 3.2 mm which is within the range of predicate device (0.75 - 4.5 mm). The new plates have also less screw holes, one at each end, and are therefore fixed with 2 screws. The predicate device plates have 4-6 screw holes, 2-3 at each end respectively. The new plates do not contain radiographic tantalum markers, while majority of the predicate device plates contain 2 tantalum markers.

#### Accessory instruments

Surgical instruments include plate templates, plate holders, drill bits and bone taps, screwdrivers, temporary fixation screw, awl and alike. The instruments are made of surgical grade stainless steel or titanium. The instruments are provided nonsterile and reusable, intended to be steam sterilized by the user prior to use. Instructions for cleaning and steam sterilization are provided with the instruments.

#### Performance testing for substantial equivalence determination

Mechanical testing was conducted to verify the strength and fixation properties of the new Inion S-2™ plates and to compare them to the predicate device. Testing included Graft push-off test, torsion test, axial tensile test, axial compression test, and cyclic compressive bending test. The results of each mechanical test show that the new plates perform within the performance range of the predicate device.

Functional and handling test and simulated clinical use test were performed to verify that the new plates, fixed with predicate device unmodified screws, using accessory instruments, packaging and Instructions for Use are functioning together as intended, and conform to the defined user needs and intended uses.

{6}------------------------------------------------

# 510(k) SUMMARY Inion Spinal Graft Containment System

The data demonstrates that the intended use, material composition and scientific technology, degradation profile and mechanical properties of new Inion S-2™ line extension plates are substantially equivalent with the predicate device Inion Spinal Graft Containment System (K071810).