The Altus Spine Pedicle Screw System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.

The Altus Spine Pedicle Screw System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origins with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor, pseudoarthrosis; and failed previous fusion in skeletally mature patients.

When used in a posterior percutaneous approach with MIS instrumentation, the Altus Spine Pedicle Screw System is intended for noncervical pedicle fixation for the following indications: degenerative dise disease (defined as back pain of discogenic origins with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor, pseudoarthrosis; and failed previous fusion in skeletally mature patients.

Device Description

The Altus Spine MIS Pedicle Screw System consists of a system of implantable screws to be used with implantable rods for the purpose of aiding in spinal fusion. The Altus Spine MIS Pedicle Screw System attaches to the vertebral body by means of screws to the non-cervical spinal and allows a surgeon to build a spinal implant construct with the intent to stabilize the spinal operative site during the fusion process of bone graft in the disc space. Implantable components are composed of titanium alloy meeting the requirements of ASTM F136. The device is supplied non-sterile and is intended for sterilization by hospital personnel.

AI/ML Overview

This document is a 510(k) Premarket Notification from the FDA regarding the Altus Spine Pedicle Screw System. It is a regulatory approval document for a medical device and therefore does not contain information about acceptance criteria or a study proving device performance as typically understood for AI/software devices.

The document concerns a physical medical device (pedicle screw system), not an AI/software device. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to engineering and biomechanical testing standards for physical implants, which are not detailed in this regulatory summary beyond a statement that "no new mechanical testing is warranted" because there are no new worst-case components.

Therefore, I cannot provide the requested information for acceptance criteria, device performance, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, or ground truth establishment. This type of information is typically found in submissions for AI/ML-based medical devices or diagnostic software.

Summary

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June 11, 2018

Altus Partners, LLC Mr. Mark Melton QA/RA Manager 1340 Enterprise Drive West Chester, Pennsylvania 19380

Re: K181281

Trade/Device Name: Altus Spine Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: NKB, KWP, KWO Dated: May 1, 2018 Received: May 15, 2018

Dear Mr. Melton:

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 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);

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Page 2 - Mr. Mark Melton

and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Ronald P. Jean -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) K181281

Device Name Altus Spine Pedicle Screw System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
AALIHULLI ALL LAND LB LEW BLAN IN LINEA WA

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8. 510(k) Summary

SUBMITTER:	Altus Partners, LLC
	1340 Enterprise Dr
	West Chester, PA 19380
	Phone: 610-356-6148
	Fax: 610-300-3049
CONTACT PERSON:	Mark Melton
	QA/RA Manager
	mmelton@altus-spine.com
DATE PREPARED:	June 11, 2018
COMMON NAME:	Pedicle Screw Spinal System
PROPRIETARY NAME:	Altus Spine Pedicle Screw System
PREDICATE DEVICES:	The Primary predicate device is the Altus Spine Pedicle Screw System(K151648).
CLASSIFICATION NAME:	21 CFR §888.3070 Thoracolumbosacral Pedicle Screw System
	21 CFR §888.3060 Spinal Intervertebral Body Fixation Orthosis
	21 CFR §888.3050 Spinal Interlaminal Fixation Orthosis
PRODUCT CODES:	NKB, KWQ, KWP
DEVICE CLASS:	Class II
MATERIAL:	The material used is Titanium Alloy material that conforms to ASTM
	F136.

DEVICE DESCRIPTION:

INDICATIONS FOR USE:

The Altus Spine MIS Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.

The Altus Spine MIS Pedicle Screw System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origins with deneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor, pseudoarthrosis; and failed previous fusion in skeletally mature patients.

When used in a posterior percutaneous approach with MIS instrumentation, the Altus Spine MIS Pedicle Screw System is intended for noncervical pedicle fixation and nonpedicle fixation for the

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following indications: degenerative disc disease (defined as back pain of discogenic origins with deneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor, pseudoarthrosis; and failed previous fusion in skeletally mature patients.

SUMMARY OF TECHNOLOGICAL CHARACTERISTICS:

The revised Altus Spine MIS Pedicle Screw System is the same as the primary predicate in regards to implant materials and surgical technique. Components have been added that are substantially equivalent to the additional predicate device.

SUMMARY OF NON-CLINAL TESTS SUBMITTED:

There are no new worst case components to this system; therefore no new mechanical testing is warranted.

SUBSTANTIAL EQUIVALENCE CONCLUSION:

The revised Altus Spine MIS Pedicle Screw System is the primary predicate in regards to implant materials and surgical technique. Components have been added that are substantially equivalent to the additional predicate device.

Altus Partners has determined that the modifications to the Altus Spine MIS Pedicle Screw System do not alter the system function, strength and stability or materials. Therefore, the revised Altus Spine MIS Pedicle Screw System is substantially equivalent to the predicate devices, and raises no new questions of safety or effectiveness.

Regulation Number and Section

N/A