SOLSTICE CROSS CONNECTOR

K120998 · Life Spine · KWP · Oct 1, 2012 · Orthopedic

Device Facts

• Record ID: K120998
• Device Name: SOLSTICE CROSS CONNECTOR
• Applicant: Life Spine
• Product Code: KWP · Orthopedic
• Decision Date: Oct 1, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput - T3), the SOLSTICE OCT System, when properly used, is intended for: Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; spinal stenosis; fracture/dislocation; Atlanto/axial fracture with instability; occipitocervical dislocation; revision of previous cervical spine surgery; and tumors. When used with the occipital plate, the bone screws are limited to occipital fixation only. The bone screws are not intended to be used in the cervical spine. The use of polyaxial screws is limited to placement in T1-T3 in treating thoracic conditions only. They are not intended to be placed in the cervical spine. The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

Device Story

SOLSTICE OCT System is a temporary, non-sterile, single-use spinal fixation system. Components include occipital plates, occipital bone screws, polyaxial screws, hooks, rods, cross connectors, and locking breakaways. System provides rigid stabilization to promote spinal fusion in the cervical and upper thoracic spine (Occiput-T3). Implanted by surgeons in clinical settings. Titanium alloy (6AL-4V-ELI) construction. Provides mechanical support to stabilize the spine following trauma, degenerative conditions, or revision surgery.

Clinical Evidence

Bench testing only. Dynamic mechanical testing performed in accordance with ASTM F1717 to demonstrate substantial equivalence.

Technological Characteristics

Constructed from medical grade titanium alloy (Ti 6Al-4V-ELI) per ASTM F136. System components include occipital plates, bone screws, polyaxial screws, hooks, rods, cross connectors, and locking breakaways. Mechanical stabilization principle. Non-sterile, single-use.

Indications for Use

Indicated for patients requiring spinal fusion in the cervical spine and occipito-cervico-thoracic junction (Occiput-T3) due to degenerative disc disease, spondylolisthesis, spinal stenosis, fracture/dislocation, atlanto/axial fracture with instability, occipitocervical dislocation, revision surgery, or tumors. Bone screws restricted to occipital fixation; polyaxial screws restricted to T1-T3 thoracic conditions. Not for cervical spine use with bone or polyaxial screws.

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

• The Sentinel Spinal System (K093043)
• Theken Atoll System (K083073)
• Biomet Altius System (K113593)
• Blackstone Ascent System (K073654)

Submission Summary (Full Text)

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K120998

Page 1 of 2

### 510(k) Summary

## SOLSTICE OCT System

Submitted By: Life Spine 2401 W. Hassell Road, Suite 1535 Hoffman Estates, IL 60169 Telephone: [phone] Fax: [phone](k) Contact: Randy Lewis RA/QA Manager Life Spine 2401 W. Hassell Road, Suite 1535 . Hoffman Estates. IL 60169 Telephone: [phone] Fax: [phone] March 13th, 2012 Date Prepared: Trade Name: Solstice OCT System Classification: K.WP, 21 CFR 888.3050, Class II, Spinal Interlaminal Fixation Orthosis. Predicate Devices: · The Sentinel Spinal System (K093043), Theken Atoll System (K083073), Biomet Altius System (K113593), Blackstone Ascent System (K073654)

### Device Description:

The SOLSTICE OCT System is a temporary, titanium alloy (6AL-4V-ELI per ASTM F 136), " multiple component system comprised of a variety of non-sterile, single use implantable components. When assembled, the components create a rigid structure providing stabilization and promote spinal fusion. The system consists of an assortment of occipital plates, occipital bone screws, polyaxial screws, hooks, rods, cross connectors and locking breakaways.

### Intended Use of the Device:

When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput - T3), the SOLSTICE OCT System, when properly used, is intended for: Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; spinal stenosis; fracture/dislocation; Atlanto/axial fracture with instability; occipitocervical dislocation; revision of previous cervical spine surgery; and tumors.

When used with the occipital plate, the bone screws are limited to occipital fixation only. The · bone screws are not intended to be used in the cervical spine.

1 2012

ОСТ

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### K120998 Page 2 of 2

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

The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

#### Technological Characteristics:

The Solstice OCT System is substantially equivalent to the predicate system in terms of design, materials, and indications for use.

### Material:

The SOLSTICE OCT System is manufactured from medical grade titanium alloy described by ASTM F136 (Ti 6Al-4V-ELI) implant grade titanium alloy.

### Performance Data:

Dynamic testing in accordance with ASTM F1717 was presented to demonstrate the substantial equivalency of the SOLSTICE OCT System.

#### Conclusion:

The indication/intended use of the modified device as described in its labeling has not changed. Furthermore, the fundamental scientific technology of the modified device has not changed. The SOLSTICE OCT System was shown to be substantially equivalent to the previously cleared devices in indications for use, design, function, and materials used.

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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 and Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The logo is simple and recognizable, representing the department's mission to protect the health of all Americans.

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

OCT 1 2012

Life Spine % Mr. Randy Lewis Regulatory Affairs, Quality Assurance Manager 2401 West Hassell Road, Suite 1535 Hoffman Estates, Illinois 60169

Re: K120998

Trade/Device Name: Solstice OCT System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: II Product Code: KWP Dated: August 29, 2012 Received: September 04, 2012

Dear Mr. Lewis:

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

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#### Page 2 - Mr. Randy Lewis

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson

Director ( ( . . Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

#### K120998 510(k) number (if known):

#### Device Name: Solstice OCT System

When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput - T3), the SOLSTICE OCT System, when properly used, is intended for: Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; spinal stenosis; fracture/dislocation; Atlanto/axial fracture with instability; occipitocervical dislocation; revision of previous cervical spine surgery; and tumors.

When used with occipital plate, the bone screws are limited to occipital fixation only. The bone screws are not intended to be used in the cervical spine.

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

The hooks, rods, and cross connectors are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

Prescription Use _ x (Part 21 CFR 801 Subpart D) And/Or

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

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(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

K120998 510(k) Number_