When used as a cervical intervertebral fusion device, the Matrixx™ System open devices are indicated for use at up to two contiguous levels in the cervical spine, from C2-T1, in skeletally mature patients who have had six weeks of non-operative treatment for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and with supplemental fixation.

When used as a lumbar intervertebral fusion device, the Matrixx® System open devices are indicated for use at one or two contiguous levels in the lumbar spine, from L2-S1, in skeletally mature patients who have had six months of non-operative the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radios. Additionally, the Matrixx™ System lumbar implants can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. The device is intended for use with autograft and or allograft comprised of cancellous and/or corticocancellous bone graft and with supplemental fixation.

When used as a vertebral body replacement device, the Matrixx™ System open and solid devices are indicated for use in the thoracolumbar spine (TI-L5) for partial replacement (i.e., partial vertebrectory) of a diseased vertebral body resected or excised for the treatment of tumors or trauma/fracture in order to achieve anterior decompression of the spinal tissues, and to restore the height of a collapsed vertebral body. The device is intended for use with autograft or allograft and with supplemental internal fixation.

Device Description

The Matrixx™ System is a collection of additively manufactured spacers for cervical, lumbar/lumbosacral and thoracolumbar implantation. The basic shape of these implants is a structural column to provide surgical stabilization of the spine. Each device comprises an external structural frame having a roughened surface (~7μm). The intervening geometric lattices have pores 300-700μm.
The inferior/superior aspects of the Matrixx™ open devices incorporate a large vertical cavity which can be packed with bone graft material. The inferior/superior aspects of the Matrixx™ solid devices are closed and do not permit the packing of bone graft within the implant. The solid devices are only to be used for partial vertebral body replacement. The open and solid devices are available in an assortment of height, length, width and lordotic angulation combinations to accommodate the individual anatomic and clinical circumstances of each patient.

AI/ML Overview

This document, K171140, is a 510(k) premarket notification for a medical device called the "Matrixx™ System," which is an implantable spinal fusion device. It is a submission to the FDA requesting clearance to market the device based on substantial equivalence to predicate devices.

The information provided does not describe a study involving an AI medical device or its performance with respect to acceptance criteria. Instead, it details the mechanical and material testing conducted for a physical implantable medical device (the Matrixx™ System) and its comparison to legally marketed predicate devices.

Therefore, I cannot extract the requested information about acceptance criteria and study data for an AI medical device from this document. The document primarily focuses on:

Device Description: Additively manufactured spacers made of Ti-6Al-4V ELI titanium alloy for cervical, lumbar/lumbosacral, and thoracolumbar implantation.
Intended Use: Spinal intervertebral fusion and vertebral body replacement.
Performance Data: Mechanical testing (static/dynamic compression, compression shear, torsion, subsidence, expulsion) according to ASTM standards (F2077, F2267, and a draft ASTM standard). The manufactured surface was evaluated according to ASTM F1978.
Conclusion: The device's mechanical test results demonstrate substantial equivalence to predicate devices.

None of the concepts you've asked about (AI, test sets, training sets, ground truth, expert adjudication, MRMC studies, human reader improvement) are relevant to the contents of this 510(k) submission for an implantable spinal device.

Summary

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

Nexxt Spine, LLC % Karen Warden, PhD President BackRoads Consulting PO Box 566 Chesterland, Ohio 44026-2141 August 22, 2017

Re: K171140

Trade/Device Name: Matrixx™ System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP, MAX, MQP Dated: July 21, 2017 Received: July 24, 2017

Dear Dr. Warden:

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

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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 (DICE) 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. 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 (DICE) 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.

Mark N. Melkerson -S

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

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K171140

Device Name MatrixxTM System

Indications for Use (Describe)

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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This section applies only to requirements of the Paperwork Reduction Act of 1995.

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510(k) Summary

Date:	17 April 2017
Sponsor:	Nexxt Spine, LLC
	14425 Bergen Blvd, Suite B
	Noblesville, IN 46060
	Office: 317.436.7801
	Fax: 317.245.2518
Sponsor Contact:	Andy Elsbury, President
510(k) Contact:	Karen E. Warden, PhD
	BackRoads Consulting Inc.
	PO Box 566
	Chesterland, OH 44026
	Office: 440.729.8457
Proposed Trade Name:	Matrixx™ System
Common Name:	Spacer system
Device Classification:	Class II
Regulation Names,Regulation Numbers,Product Codes:	Spinal vertebral body replacement device, 888.3060, MQPIntervertebral fusion device with bone graft, 888.3080, lumbar/cervical,MAX/ODP
Device Description:	The Matrixx™ System is a collection of additively manufactured spacers forcervical, lumbar/lumbosacral and thoracolumbar implantation. The basicshape of these implants is a structural column to provide surgicalstabilization of the spine. Each device comprises an external structuralframe having a roughened surface (~7μm). The intervening geometriclattices have pores 300-700μm.The inferior/superior aspects of the Matrixx™ open devices incorporate alarge vertical cavity which can be packed with bone graft material. Theinferior/superior aspects of the Matrixx™ solid devices are closed and donot permit the packing of bone graft within the implant. The solid devicesare only to be used for partial vertebral body replacement. The open andsolid devices are available in an assortment of height, length, width andlordotic angulation combinations to accommodate the individual anatomicand clinical circumstances of each patient.
Indications for Use:	When used as a cervical intervertebral fusion device, the Matrixx™ Systemopen devices are indicated for use at up to two contiguous levels in thecervical spine, from C2-T1, in skeletally mature patients who have had sixweeks of non-operative treatment for the treatment of degenerative discdisease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined asneck pain of discogenic origin with degeneration of the disc confirmed byhistory and radiographic studies. The device is intended for use withautograft and/or allograft comprised of cancellous and/or corticocancellousbone graft and with supplemental fixation.When used as a lumbar intervertebral fusion device, the Matrixx™ Systemopen devices are indicated for use at one or two contiguous levels in thelumbar spine, from L2-S1, in skeletally mature patients who have had sixmonths of non-operative treatment for the treatment of degenerative discdisease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined asback pain of discogenic origin with degeneration of the disc confirmed byhistory and radiographic studies. Additionally, the Matrixx™ System lumbarimplants can be used as an adjunct to fusion in patients diagnosed withdegenerative scoliosis. The device is intended for use with autograft and/orallograft comprised of cancellous and/or corticocancellous bone graft and
	with supplemental fixation.When used as a vertebral body replacement device, the Matrixx™ Systemopen and solid devices are indicated for use in the thoracolumbar spine (T1-L5) for partial replacement (i.e., partial vertebrectomy) of a diseasedvertebral body resected or excised for the treatment of tumors ortrauma/fracture in order to achieve anterior decompression of the spinalcord and neural tissues, and to restore the height of a collapsed vertebralbody. The device is intended for use with autograft or allograft and withsupplemental internal fixation.
Materials:	Matrixx™ System implants are manufactured from Ti-6Al-4V ELI titaniumalloy (ASTM F3001).
Primary Predicate:	Primary: Cascadia Interbody System (K2M Inc. - K160125)
Additional Predicates:	Additional: Honour System (Nexxt Spine, LLC – K120345), Lumbar I/FCage (DePuy Spine – P960025)
Performance Data:	Mechanical testing of worst case Matrixx™ System devices included staticand dynamic compression, static and dynamic compression shear andstatic torsion according to ASTM F2077. In addition, the subsidenceproperties were evaluated according to ASTM F2267 and expulsionaccording to the ASTM draft standard. The manufactured surface wasevaluated according to ASTM F1978.The mechanical test results demonstrate that Matrixx™ Systemperformance is substantially equivalent to the predicate devices.
Technological Characteristics:	The Matrixx™ System possesses the same technological characteristics asone or more of the predicate devices. These include: intended use (as described above) basic design (additively manufactured structure) material (titanium alloy) sizes (dimensions are comparable to those offered by the predicate systems) and The Matrixx™ System is the same as previously cleared devices.
Conclusion:	The Matrixx™ System possesses the same intended use and technologicalcharacteristics as the predicate devices. Therefore Matrixx™ System issubstantially equivalent for its intended use.

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Regulation Number and Section

§ 888.3080 Intervertebral body fusion device.

(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.