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); 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 thoracic screws is limited to placement in T1-T3 for anchoring the construct only. They are not intended to be placed in the cervical spine.

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

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. The system consists of an assortment of occipital plates, occipital bone screws, polyaxial screws, hooks, rods, locking caps and breakaways.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the SOLSTICE OCT System. It is an FDA submission for substantial equivalence to legally marketed predicate devices, not a study describing acceptance criteria and device performance in the context of an AI/software as a medical device.

Therefore, the requested information regarding acceptance criteria, reported device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set information is not available within this document. The document focuses on regulatory compliance for a physical spinal implant system.

The "Performance Data" section mentions "Mechanical Testing consisting of static and dynamic compression and torsion in accordance with ASTM 2706 as well interconnection testing was presented to show the substantial equivalence of the SOLSTICE OCT System." This refers to physical engineering tests, not clinical or algorithmic performance.

Summary

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

April 23, 2015

Life Spine, Incorporated Mr. Randy Lewis General Manager 13951 South Quality Drive Huntley, Illinois 60142

Re: K142253

Trade/Device Name: SOLSTICE OCT System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: KWP Dated: March 23, 2015 Received: March 24, 2015

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 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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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) K142253

Device Name Solstice OCT System

Indications for Use (Describe)

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 thoracic screws is limited to placement in T1-T3 for anchoring the construct only. They are not intended to be placed in the cervical spine.

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

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

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510(k) Summary SOLSTICE® OCT System

Submitted By:	Life Spine, Inc.13951 S Quality DriveHuntley, IL 60142Telephone: 847-884-6117Fax: 847-884-6118
510(k) Contact:	Randy LewisLife Spine13951 S Quality DriveHuntley, IL 60142Telephone: 847-884-6117Fax: 847-884-6118
Date Prepared:	March 18th, 2015
Trade Name:	SOLSTICE OCT System
Common Name:	Spinal interlaminal fixation orthosis
Classification:	KWP, CFR 888.3050, Class II
Primary Predicate:	Sentinel Spinal System (K090343)
Additional Predicate:	Theken Atoll OCT System (K083863)

Device Description:

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

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The use of thoracic screws is limited to placement in T1-T3 for anchoring the construct 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, indications for use and sizing.

Material:

The SOLSTICE OCT System is 6AL-4V-ELI titanium manufactured according to ASTM F136. The device is comprised of a variety of non-sterile titanium, single use components.

Performance Data:

Mechanical Testing consisting of static and dynamic compression and torsion in accordance with ASTM 2706 as well interconnection testing was presented to show the substantial equivalence of the SOLSTICE OCT System.

Conclusion:

The information presented demonstrates the substantial equivalency of The SOLSTICE OCT System.

Regulation Number and Section

§ 888.3050 Spinal interlaminal fixation orthosis.

(a)
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.(b)
Classification. Class II.