NEXTGEN ALTIUS OCT SYSTEM

K140734 · Ebi, LLC · KWP · Dec 15, 2014 · Orthopedic

Device Facts

• Record ID: K140734
• Device Name: NEXTGEN ALTIUS OCT SYSTEM
• Applicant: Ebi, LLC
• Product Code: KWP · Orthopedic
• Decision Date: Dec 15, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

When intended for stabilization as an adjunct to fusion of the cervical spine and occipito-cervico-thoracic junction (occiput -T3), the Nextgen Altius OCT System is intended for use with allograft or autograft and indicated for: DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies); spondylolisthesis; deformities or curvatures (i.e., scoliosis); pseudoarthrosis; spinal stenosis; trauma, (i.e., fracture or dislocation); atlanto/axial fracture with instability; occipitocervical dislocation; revision of previous cervical spine surgery; and tumors. The occipital bone screws are limited to occipital fixation only. The use of pedicle screws is limited to placement in T1-T3 in treating thoracic conditions only. They are not intended to be placed in or treat conditions involving the cervical spine. The Nextgen Altius OCT System can also be linked to the Biomet Polaris Systems via transitional rods or using Altius Rod Connectors or Polaris Dominoes. Please refer to the individual system's package insert for a list of indications for use for each system.

Device Story

Nextgen Altius OCT System is a spinal fixation system; provides stabilization as an adjunct to fusion of cervical spine and occipito-cervico-thoracic junction (occiput-T3). System components include multiaxial screws, rods, and connectors; allows linkage to Biomet Polaris Systems via transitional rods or connectors. Used by surgeons in clinical settings to treat degenerative disc disease, deformities, trauma, and tumors. Device provides mechanical support to the spine; facilitates fusion when used with autograft or allograft. Output is a rigid construct stabilizing the spinal segments; assists in patient recovery by correcting instability and deformity.

Clinical Evidence

Bench testing only. Mechanical testing conducted per FDA guidance for spinal systems and ASTM standards (F1717, F1798) including static interconnection, compression bending fatigue, and dissociation testing. Results demonstrate substantial equivalence to predicate systems.

Technological Characteristics

Spinal interlaminal fixation orthosis; multiaxial screw system. Components designed for occipito-cervico-thoracic fixation. Mechanical testing performed per ASTM F1717 (vertebrectomy model) and ASTM F1798 (interconnection mechanisms). System allows modular connectivity with Biomet Polaris Systems via transitional rods and connectors.

Indications for Use

Indicated for patients requiring stabilization as an adjunct to fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3) for conditions including DDD, spondylolisthesis, deformities (scoliosis), pseudoarthrosis, spinal stenosis, trauma (fracture/dislocation), atlanto/axial fracture with instability, occipitocervical dislocation, revision surgery, and tumors. Occipital screws limited to occipital fixation; pedicle screws limited to T1-T3 thoracic conditions only.

Regulatory Classification

Identification

A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.

Predicate Devices

• Nextgen Altius OCT System (K122378)
• Nextgen Altius OCT System (K113593)
• Nextgen Altius OCT System (K043229)
• Medtronic Vertex Reconstruction System (K110522)
• Lanx Posterior Cervicothoracic Spinal Fixation System (K113434)
• Lanx Posterior Cervicothoracic Spinal Fixation System (K071905)

Submission Summary (Full Text)

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

December 15, 2014

Biomet Spine (aka EBI, LLC) Mr. Ted Kuhn Regulatory Affairs Product Manager 399 Jefferson Road Parsippany, New Jersey 07054

Re: K140734

Trade/Device Name: Nextgen Altius OCT System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: KWP, MNI, MNH Dated: November 13, 2014 Received: November 14, 2014

Dear Mr. Kuhn:

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. 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.

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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/Resourcesfor You/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.

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,

# Lori A. Wiggins -S

for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K140734

Device Name Nextgen Altius OCT System

#### Indications for Use (Describe)

When intended for stabilization as an adjunct to fusion of the cervical spine and occipito-cervico-thoracic junction (occiput -T3), the Nextgen Altius OCT System is intended for use with allograft or autograft and indicated for: DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies); spondylolisthesis; deformities or curvatures (i.e., scoliosis); pseudoarthrosis; spinal stenosis; trauma, (i.e., fracture or dislocation); atlanto/axial fracture with instability; occipitocervical dislocation; revision of previous cervical spine surgery; and tumors.

The occipital bone screws are limited to occipital fixation only.

The use of pedicle screws is limited to placement in T1-T3 in treating thoracic conditions only.

They are not intended to be placed in or treat conditions involving the cervical spine.

The Nextgen Altius OCT System can also be linked to the Biomet Polaris Systems via transitional rods or using Altius Rod Connectors or Polaris Dominoes. Please refer to the individual system's package insert for a list of indications for use for each system.

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------|-----------------------------------------------------------|
| <span></span> Prescription Use (Part 21 CFR 801 Subpart D) | <span></span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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Image /page/3/Picture/0 description: The image shows the logo for Biomet Spine. The logo is in black and white and features the word "BIOMET" in a stylized font. Below the word "BIOMET" is the word "SPINE" in a smaller, sans-serif font. The logo is simple and modern.

# 10(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR § 807.92.

| Preparation Date: | December 15, 2014 |
|----------------------------------------|-----------------------------------------------------------------------------------------------------|
| Applicant/Sponsor: | Biomet Spine<br>399 Jefferson Road<br>Parsippany, NJ 07054 |
| Contact Person: | Ted Kuhn<br>Phone: [phone]<br>Fax: [phone] |
| Trade name: | Nextgen Altius OCT System |
| Common Name: | Occipito-cervico-thoracic spinal fixation system |
| Product Code & Classification<br>Name: | KWP - Spinal interlaminal fixation orthosis<br>MNI & MNH – Noncervical, pedicle screw spinal system |
| Device Panel - Regulation No.: | Orthopedic - 21 CFR 888 3050 and 888 3070 |

## Device Description:

This submission is a line extension to Nextgen Altius OCT System to add an alternate style of multiaxial screws to the system.

### Indications for Use:

When intended for stabilization as an adjunct to fusion of the cervical spine and occipitocervico-thoracic junction (occiput -T3), the Nextgen Altius OCT System is intended for use with allograft or autograft and indicated for: DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies); spondylolisthesis; deformities or curvatures (i.e., scoliosis, kyphosis and/or lordosis); pseudoarthrosis; spinal stenosis; trauma, (i.e., fracture or dislocation); atlanto/axial fracture with instability; occipitocervical dislocation; revision of previous cervical spine surgery; and tumors.

The occipital bone screws are limited to occipital fixation only.

The use of pedicle screws is limited to placement in T1-T3 in treating thoracic conditions only. They are not intended to be placed in or treat conditions involving the cervical spine.

The Nextgen Altius OCT System can also be linked to the Biomet Polaris Systems via transitional rods or using Altius Rod Connectors or Polaris Dominoes. Please refer to the individual system's package insert for a list of indications for use for each system.

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#### Summary of Technologies:

The technological characteristics of the new components are the same as, or similar to, the predicate devices in regards to design, indications for use and operational principle.

#### Performance Data:

Mechanical testing was conducted in accordance with FDA's Guidance for Industry and FDA Staff - Spinal System 510(k)s dated May 3, 2004. Per the guidance document, the following testing was conducted: static interconnection testing and compression bending fatigue. Testing was conducted in accordance with ASTM F1717, Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model and ASTM F1798, Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants. Dissociation testing was also conducted. The mechanical testing verifies that the subject components are substantially equivalent to other spinal systems currently on the market and has met all mechanical test requirements based on the worst-case construct testing.

#### Substantial Equivalence:

The subject components being added to the Nextgen Altius OCT System are substantially equivalent to the current components in the primary predicate Nextgen Altius OCT System (K122378) and the following additional predicates: Nextgen Altius OCT System (K113593 and K043229), Medtronic Vertex Reconstruction System (K110522), and Lanx Posterior Cervicothoracic Spinal Fixation System (K113434 and K071905). The Nextgen Altius OCT System is substantially equivalent to these predicate systems with respect to intended use and indications, technological characteristics, and principles of operation and do not present any new issues of safety or effectiveness.

### Conclusion:

The Nextgen Altius OCT System is substantially equivalent to the predicate systems when used as an occipito-cervico-thoracic spinal fixation device. The intended use and fundamental technology of the system remain unchanged. Furthermore, mechanical testing and other supporting information sufficiently demonstrate the substantial equivalence of the subject components to the other components in the Nextgen Altius OCT System. Based on this information, the subject components do not raise any new issues regarding the safety or efficacy.